Cardiac ArrestPediAppRRESTNCT04619498
Effectiveness of an Interactive Cognitive Support Tablet App to Improve the Management of Pediatric Cardiac Arrest
A study testing PediAppRREST and AHA-PALS pocket reference card in people with Cardiac Arrest, run by University of Padova at 4 sites in Italy.
Trial summary
Pediatric cardiac arrest (PCA) has a high mortality and morbidity. Its management is complex and often deviates from guideline recommendations leading to patients' worse clinical outcomes. A new tablet app, named PediAppRREST has been developed by our research group to support the management of PCA. Read more about this study
- Who is it for?
- Ages 24 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- PediAppRREST and AHA-PALS pocket reference card
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 4 sitesItaly
- Study dates
- 21 Sep 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- to be attending a medical residency training program in Pediatrics, Anesthesiology-Intensive Care or Emergency Medicine
- to be BLS (Basic Life Support) or P-BLS (Pediatric-Basic Life Support) or PALS (Pediatric Advanced Life Suport) or ALS (Advanced Life Support) or ACLS (Advanced Cardiac Life Support) certified, following the American Heart Association (AHA) or the European Resuscitation Council (ERC) courses
- to give consent to participate to the study and to be video-recorded.
- Additionally, to be eligible for the role of team leader, residents must be PALS-certified according to AHA or ERC guidelines
Who cannot join
- to be unable to attend the simulation sessions because of personal leave, maternity/paternity leave, sick leave or training abroad
- participation in previous studies using the PediAppRREST app
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
Azienda Ospedaliera Universitaria Meyer, University of Firenze
Florence
Azienda Ospedaliera Universitaria Maggiore della Carità, Università del Piemonte Orientale
Novara
Azienda Ospedale Università di Padova, University of Padova
Padova
Policlinico Universitario Agostino Gemelli, Università Cattolica del Sacro Cuore
Roma
About this study
Official title: PediAppRREST - Effectiveness of an Interactive Cognitive Support Tablet App in Reducing Deviations From Guidelines in the Management of Pediatric Cardiac Arrest: a Simulation-based Randomized Controlled Trial
Pediatric cardiac arrest (PCA) has a high mortality and morbidity. Its management is complex and often deviates from guideline recommendations leading to patients' worse clinical outcomes. A new tablet app, named PediAppRREST has been developed by our research group to support the management of PCA. The aim of the study is to evaluate the impact of the PediAppRREST app on the management of a PCA simulated scenario. The investigators have planned to conduct a multicenter, simulation-based, randomized control trial assessing the number of deviations (errors and delays) from international recommendations in PCA management. The hypothesis is that teams who use the PediAppRREST app as a cognitive aid will show fewer deviations from guidelines than teams who use a static paper-based cognitive aid (American Heart Association Pediatric Advanced Life Support pocket reference card) or no cognitive aid, during the management of a simulated PCA scenario.
Read the detailed description
AIMS
The primary aim of the study is to evaluate the effectiveness of a new tablet app, named PediAppRREST, in reducing deviations from guideline recommendations during pediatric cardiac arrest management.
The secondary aim is to assess the impact of the use of the app on performance and time to accomplish critical interventions for resuscitation, team leader's workload, cardiopulmonary resuscitation quality metrics and overall resuscitation team performance. Furthermore, the study will have the purpose to evaluate the usability of the app.
METHODS
PARTICIPANTS
Participants will be residents in Pediatrics, Emergency Medicine, and Anesthesiology-Intensive Care programs at four Italian University Hospitals (Padova, Firenze, Novara, and Roma). In order to be included in the study, residents must be BLS (Basic Life Support) or P-BLS (Pediatric-Basic Life Support) or PALS (Pediatric Advanced Life Support) or ALS (Advanced Life Support) or ACLS (Advanced Cardiac Life Support) certified, following the American Heart Association (AHA) or the European Resuscitation Council (ERC) recommendations. Additionally, to be eligible for the role of team leader residents must be PALS-certified according to AHA or ERC guidelines. Those residents who are unable to attend the simulation sessions because of maternity/paternity leave, personal/sick leave or training abroad, or who have participated in previous studies using the PediAppRREST app will not be eligible to participate in the trial.
STUDY DESIGN
This will be a multicenter, randomized controlled, three-parallel arm study, conducted in the setting of simulation. All teams, each consisting of three participants, will manage the same scenario of non-shockable pediatric cardiac arrest with the help of one confederate nurse who will act according to a script. Participants will be randomized to teams, and teams to interventions, using a 1:1:1 ratio. According to the allocation into one of three study arms, teams will use, or not use, a different PALS-related cognitive aid during the management of the scenario: 1) an intervention group using the tablet app PediAppRREST; or 2) a control group (CtrlPALS+) using the AHA-PALS pocket reference card; or 3) a control group (CtrlPALS-) not allowed to use any cognitive aid.
All the simulation scenarios will be video recorded, and two independent, previously trained reviewers will report actions performed by the teams and time to accomplish them. Outcomes will be subsequently assessed by two independent outcome assessors using data extracted by video reviewers.
OUTCOMES
The primary outcome of the study will be the number of deviations from AHA PALS guidelines recommendations during the management of pediatric cardiac arrest, defined as delays and errors according to a novel checklist, named c-DEV15plus, based on previously published guidelines, checklists and scoring systems/evaluation tools.
The secondary outcomes will be the performance of critical actions for resuscitation and the time to perform them, the usability of the app (measured by open-ended questions and one validated questionnaire: the System Usability Scale), the team leaders' workload (measured by the validated NASA-Task Load Index), the quality metrics of cardiopulmonary resuscitation (extracted by the manikin's software SkillReporter, Laerdal™) according to AHA guidelines, and the overall team resuscitation performance (measured by the validated Clinical Performance Tool).
SAMPLE SIZE CALCULATION
The investigators calculated the sample size on the basis of the results obtained during two previous studies: one observational simulation-based study and one pilot study conducted to test the app usability. Based on the preliminary results from these studies, using a single factor ANOVA model, 29 scenarios per each of the three groups (PediAppRREST, CtrlPALS+, CtrlPALS-) are necessary to detect a difference of at least 3.00 points on the c-DEV15plus scale using the Tukey-Kramer (Pairwise) multiple comparison procedure at a 5% significance level and 80% power. In consideration that some possible technical problems with video-recording or other study procedures could occur, the investigators aim to increase the recruitment of participating teams by 20% per arm, to compensate for loss of statistical power due to a potential insufficient sample size. Hence, the investigators plan to have 35 scenarios per arm, for a total of 105 scenarios, which will include overall 315 residents who will be divided in teams of three.
STATISTICAL ANALYSIS
The c-DEV15plus scale, the performance and time to accomplish specific resuscitation interventions, workload, overall team performance and cardiopulmonary resuscitation metrics will be compared between groups with one-way ANOVA model, followed by the Tukey-Kramer multiple comparisons adjustment procedure in case of statistical significance. The outcomes will also be analyzed with a linear mixed model considering the team as a cluster to evaluate the influence of participants' characteristics on the outcome. To take into account the correlation of the observations within a team, the investigators will specify an undetermined correlation matrix. In case of a not normal distribution of the model residuals, the investigators will proceed with a transformation in order to normalize the distribution.
CONFIDENTIALITY AND PRIVACY PROTECTION
A written informed consent to take part into the study will be obtained from each participant. To ensure that the data collected remains confidential, all data and videos will be stored on password protected and secured hard-disk drives, that will be stored in locked filing cabinets located at the Department of Women's and Children's health, University of Padova, Italy.
- Conditions
- Cardiac Arrest
- Being tested
- PediAppRREST, AHA-PALS pocket reference card
- Keywords
- cardiac arrest, resuscitation, cognitive aid, mobile app, emergency medicine, simulation, pediatrics
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PediAppRRESTDevice
PediAppRREST is a new audiovisual interactive app for tablets developed to support the management of pediatric cardiac arrest. It sequentially displays directions on recommended management interventions. It was specifically designed to guide the team leader to perform resuscitation interventions in the sequence/timing and modality reported by the American Heart Association Pediatric Advanced Life Support (AHA-PALS) guidelines.
AHA-PALS pocket reference cardOther
It is a 10 cm x 16.5 cm, full-color, 2-sided, 6-panel card that shows the American Heart Association Pediatric Advanced Life Support (AHA-PALS) treatment algorithms. By providing a quick reference tool, it serves as a cognitive aid for healthcare providers who either direct or participate in the management of pediatric respiratory and/or cardiovascular emergencies, including cardiac arrest.
| Study group | Role | What they receive |
|---|---|---|
| PediAppRREST app | Experimental | The teams assigned to the PediAppRREST arm will manage the simulated scenario of pediatric cardiac arrest using the new PediAppRREST tablet app as a cognitive aid. Receives: Device: PediAppRREST |
| CtrlPALS+ | Active comparator | The teams assigned to the CtrlPALS+ arm will manage the simulated scenario of pediatric cardiac arrest using the American Heart Association Pediatric Advanced Life Support (AHA-PALS) pocket reference card. Receives: Other: AHA-PALS pocket reference card |
| CtrlPALS- | No intervention | The teams assigned to the CtrlPALS- arm will manage the simulated scenario of pediatric cardiac arrest using no PALS-related cognitive aids. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deviations from American Heart Association Pediatric Advanced Life Support (AHA-PALS) guidelines
Deviations from AHA-PALS guidelines recommendations are defined as delays and errors according to a novel checklist we derived from a previously published checklist, denominated c-DEV (circulation-deviations), published by Wolfe et al. (2020), by integrating it with evidence-based guidelines, previously reported scoring tools and checklists. We named our new modified checklist c-DEV15plus (circulation-deviations 15 plus). It includes 15 items, which represent correct critical actions for pediatric resuscitation. Each item of the c-DEV15plus is scored either as 0, when the action is performed correctly and timely, as described in the item, or as 1, when the action is not undertaken, undertaken incorrectly, or with wrong timing. The sum of the points attributed to the items represents the c-DEV15plus total score, hence ranging from a minimum of 0 to a maximum of 15, with higher scores corresponding to a higher number of deviations from the guidelines and a worse performance.
Measured: Scenario will be video recorded and evaluated by two independent video reviewers. Outcome assessors will score teams' performance by means of the c-DEV15plus score using data extracted by video reviewers through study completion, an average of 15 months.
Secondary outcomes (34)
Recognition of cardiac arrest (pulsenessness)
The percentage of teams that recognize cardiac arrest (pulselessness).
Measured: Scenario will be video recorded and successively two independent video reviewers will assess the pulsessness recognition, through study completion, an average of 15 months.
Time to cardiac arrest (pulsenessness) recognition
Time from the beginning of the scenario to the recognition of cardiac arrest (pulselessness), in seconds.
Measured: Scenario will be video recorded and successively two independent video reviewers will assess the time to pulselessness recognition, through study completion, an average of 15 months.
Performance of chest compressions
Percentage of teams that start chest compressions.
Measured: Scenario will be video recorded and successively two independent video reviewers will assess the performance of chest compressions, through study completion, an average of 15 months.
Time to start chest compressions from arrest recognition
Time from the recognition of cardiac arrest to the start of chest compressions, in seconds.
Measured: Scenario will be video recorded and successively two independent video reviewers will assess the time to start chest compressions, through study completion, an average of 15 months.
Time to start chest compressions from the beginning of the scenario
Time from the beginning of the scenario to the start of chest compressions, in seconds.
Measured: Scenario will be video recorded and successively two independent video reviewers will assess the time to start chest compressions, through study completion, an average of 15 months.
Performance of ventilation
Percentage of teams that start ventilation.
Measured: Scenario will be video recorded and successively two independent video reviewers will assess the start of ventilation, through study completion, an average of 15 months.
Time to start of ventilation from arrest recognition
Time from the recognition of cardiac arrest to the start ventilation, in seconds.
Measured: Scenario will be video recorded and successively two independent video reviewers will assess the time to start ventilation, through study completion, an average of 15 months.
Time to start of ventilation from the beginning of the scenario
Time from the beginning of the scenario to the start ventilation, in seconds.
Measured: Scenario will be video recorded and successively two independent video reviewers will assess the time to start ventilation, through study completion, an average of 15 months.
Use a cardiopulmonary resuscitation board or a rigid surface underneath the manikin
Percentage of teams that use a cardiopulmonary resuscitation board or a rigid surface underneath the manikin.
Measured: Scenario will be video recorded and successively two independent video reviewers will assess the use of a cardiopulmonary resuscitation board or a rigid surface underneath the manikin, through study completion, an average of 15 months.
Time to use a cardiopulmonary resuscitation board or a rigid surface underneath the manikin from arrest recognition
Time from the recognition of cardiac arrest to the use of a cardiopulmonary resuscitation board or a rigid surface underneath the manikin, in seconds.
Measured: Scenario will be video recorded and successively two independent video reviewers will assess the time to use a cardiopulmonary resuscitation board or a rigid surface underneath the manikin, through study completion, an average of 15 months.
Time to use a cardiopulmonary resuscitation board or a rigid surface underneath the manikin from the beginning of the scenario
Time from the beginning of the scenario to the use of a cardiopulmonary resuscitation board or a rigid surface underneath the manikin, in seconds.
Measured: Scenario will be video recorded and successively two independent video reviewers will assess the time to use a cardiopulmonary resuscitation board or a rigid surface underneath the manikin, through study completion, an average of 15 months.
Call for emergency team help
Percentage of teams that call for emergency team help.
Measured: Scenario will be video recorded and successively two independent video reviewers will assess the call for emergency team help, through study completion, an average of 15 months.
Time to call for emergency team help from arrest recognition
Time from the recognition of cardiac arrest to call for emergency team help, in seconds.
Measured: Scenario will be video recorded and successively two independent video reviewers will assess the time to call for emergency team help, through study completion, an average of 15 months.
Time to call for emergency team help from the beginning of the scenario
Time from the beginning of the scenario to call for emergency team help, in seconds.
Measured: Scenario will be video recorded and successively two independent video reviewers will assess the time to call for emergency team help, through study completion, an average of 15 months.
Use of electrocardiogram monitoring
Percentage of teams that use of electrocardiogram monitoring.
Measured: Scenario will be video recorded and successively two independent video reviewers will assess the use of electrocardiogram monitoring, through study completion, an average of 15 months.
Time to start electrocardiogram monitoring from arrest recognition
Time from cardiac arrest recognition to start of electrocardiogram monitoring, in seconds.
Measured: Scenario will be video recorded and successively two independent video reviewers will assess the time to start electrocardiogram monitoring, through study completion, an average of 15 months.
Time to start electrocardiogram monitoring from the beginning of scenario
Time from the beginning of the scenario to start of electrocardiogram monitoring, in seconds.
Measured: Scenario will be video recorded and successively two independent video reviewers will assess the time to start electrocardiogram monitoring, through study completion, an average of 15 months.
Administration of a correct first epinephrine
Percentage of teams that perform a correct first epinephrine administration (correct dose, dilution, route, followed by a normal saline flush).
Measured: Scenario will be video recorded and successively two independent video reviewers will assess the correct administration of the first epinephrine, through study completion, an average of 15 months.
Time to first epinephrine administration from arrest recognition
Time from the recognition of cardiac arrest to the first epinephrine administration, in seconds.
Measured: Scenario will be video recorded and successively two independent video reviewers will assess the time to the first epinephrine administration, through study completion, an average of 15 months.
Time to first epinephrine administration from the beginning of the scenario
Time from the beginning of the scenario to the first epinephrine administration, in seconds.
Measured: Scenario will be video recorded and successively two independent video reviewers will assess the time to the first epinephrine administration, through study completion, an average of 15 months.
Administration of a correct second epinephrine
Percentage of teams that perform a correct second epinephrine administration (correct dose, dilution, route, followed by a normal saline flush).
Measured: Scenario will be video recorded and successively two independent video reviewers will assess the correct administration of the second epinephrine dose, through study completion, an average of 15 months.
Time to second epinephrine administration from arrest recognition
Time from the recognition of cardiac arrest to the second epinephrine administration, in seconds.
Measured: Scenario will be video recorded and successively two independent video reviewers will assess the time to second epinephrine administration, through study completion, an average of 15 months.
Time to second epinephrine administration from the beginning of the scenario
Time from the beginning of the scenario to the second epinephrine administration, in seconds.
Measured: Scenario will be video recorded and successively two independent video reviewers will assess the time to second epinephrine administration, through study completion, an average of 15 months.
Treatment of reversible causes
Percentage of teams that correctly treat at least one reversible cause (hypovolemia or hypoglycemia).
Measured: Scenario will be video recorded and successively two independent video reviewers will assess the correct treatment of reversible causes, through study completion, an average of 15 months.
Time to treatment of reversible causes from arrest recognition
Time from the recognition of cardiac arrest to the treatment of reversible causes, in seconds.
Measured: Scenario will be video recorded and successively two independent video reviewers will assess the time to treatment of reversible causes, through study completion, an average of 15 months.
Time to treatment of reversible causes from the beginning of the scenario
Time from the beginning of the scenario to the treatment of reversible causes, in seconds.
Measured: Scenario will be video recorded and successively two independent video reviewers will assess the time to treatment of reversible causes, through study completion, an average of 15 months.
Usability of the app - System Usability Scale
To assess the PediAppRREST app usability, the team leaders of the intervention group will complete one validated questionnaire, the System Usability Scale (SUS). It consists of a 10-item questionnaire with five response options. Its scores ranges from a minimum of 0 to a maximum of 100. Higher scores corresponde to a better usability.
Measured: Questionnaires will be completed after each simulated scenario through study completion, an average of 15 months.
Usability of the app - Open-ended questions
To further assess the PediAppRREST app usability, the team leaders of the intervention group will answer open-ended questions about app usability in a questionnaire.
Measured: Questionnaires will be completed after each simulated scenario through study completion, an average of 15 months.
Team leaders' workload
Team leaders' workload measured by the validated, multidimensional NASA-Task Load Index (NASA-TLX) questionnaire. The values of this score range from a minimum of 0 to a maximum of 100. A higher value means a higher perceived workload.
Measured: Questionnaires will be completed by team leaders after each simulated scenario through study completion, an average of 15 months.
Cardiopulmonary resuscitation (CPR) quality - Mean chest compression rate
CPR quality will be measured by the Skill Reporter (Laerdal™), the software associated to the manikin (Resusci Junior, Laerdal™). Mean chest compression rate is expressed in number of compressions/minute.
Measured: CPR quality data will be extracted by the manikin's software after each simulated scenario, through study completion, an average of 15 months.
Cardiopulmonary resuscitation (CPR) quality metrics - Mean chest compression depth
CPR quality will be measured by the Skill Reporter (Laerdal™), the software associated to the manikin (Resusci Junior, Laerdal™). The mean chest compression depth is reported in millimeters.
Measured: CPR quality data will be extracted by the manikin's software after each simulated scenario, through study completion, an average of 15 months.
Cardiopulmonary resuscitation (CPR) quality metrics - Compression depth correctness
CPR quality will be measured by the Skill Reporter (Laerdal™), the software associated to the manikin (Resusci Junior, Laerdal™). Compression depth correctness is defined as the proportion of chest compressions with a correct depth of 50-60 mm, according to AHA standards.
Measured: CPR quality data will be extracted by the manikin's software after each simulated scenario, through study completion, an average of 15 months.
Cardiopulmonary resuscitation (CPR) quality metrics - Chest compressions fraction
CPR quality will be measured by the Skill Reporter (Laerdal™), the software associated to the manikin (Resusci Junior, Laerdal™). The chest compression fraction is defined as the proportion of resuscitation time during which chest compressions are administered.
Measured: CPR quality data will be extracted by the manikin's software after each simulated scenario, through study completion, an average of 15 months.
Team resuscitation performance
Team resuscitation performance will be evaluated using the Clinical Performance Tool (CPT). The CPT is a validated scoring system designed based on AHA PALS algorithms, through which sequence, timing, and quality of specific actions, during different simulated scenarios, can be assessed. Outcome assessors will use the CPT section for the asystole scenario to evaluate teams' performance. The values of this score range from a minimum of 0 to a maximum of 13. Higher scores correspond to a better team performance.
Measured: Scenario will be video recorded and successively evaluated by two independent video reviewers. Outcome assessors will score teams' performance by means of CPT using data extracted by video reviewers, through study completion, an average of 15 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start21 Sep 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, three-parallel arm study
- Masking
- None (open label)
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florence, Catholic University of the Sacred Heart, Università degli Studi del Piemonte Orientale Amedeo Avogadro
- Responsible party
- Principal investigator, Silvia Bressan, University of Padova
- Investigators
- Silvia Bressan, MD, PhD, Principal investigator, University of PadovaFrancesco Corazza, MD, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619498
- Sponsor's protocol ID
- BIRD191291
- Acronym
- PediAppRREST
- Status last verified
- May 2022
- First submitted
- 14 Oct 2020
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Corazza F, Snijders D, Arpone M, Stritoni V, Martinolli F, Daverio M, Losi MG, Soldi L, Tesauri F, Da Dalt L, Bressan S. Development and Usability of a Novel Interactive Tablet App (PediAppRREST) to Support the Management of Pediatric Cardiac Arrest: Pilot High-Fidelity Simulation-Based Study. JMIR Mhealth Uhealth. 2020 Oct 1;8(10):e19070. doi: 10.2196/19070.
PubMed 32788142Wolfe HA, Morgan RW, Zhang B, Topjian AA, Fink EL, Berg RA, Nadkarni VM, Nishisaki A, Mensinger J, Sutton RM; American Heart Association's Get With the Guidelines-Resuscitation Investigator. Deviations from AHA guidelines during pediatric cardiopulmonary resuscitation are associated with decreased event survival. Resuscitation. 2020 Apr;149:89-99. doi: 10.1016/j.resuscitation.2020.01.035. Epub 2020 Feb 11.
PubMed 32057946Corazza F, Arpone M, Tardini G, Stritoni V, Mormando G, Graziano A, Navalesi P, Fiorese E, Portalone S, De Luca M, Binotti M, Tortorolo L, Salvadei S, Nucci A, Monzani A, Genoni G, Bazo M, Cheng A, Frigo AC, Da Dalt L, Bressan S. Effectiveness of a Novel Tablet Application in Reducing Guideline Deviations During Pediatric Cardiac Arrest: A Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2327272. doi: 10.1001/jamanetworkopen.2023.27272.
PubMed 37535352Corazza F, Arpone M, Snijders D, Cheng A, Stritoni V, Ingrassia PL, De Luca M, Tortorolo L, Frigo AC, Da Dalt L, Bressan S. PediAppRREST: effectiveness of an interactive cognitive support tablet app in reducing deviations from guidelines in the management of paediatric cardiac arrest: protocol for a simulation-based randomised controlled trial. BMJ Open. 2021 Jul 28;11(7):e047208. doi: 10.1136/bmjopen-2020-047208.
PubMed 34321297
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PediAppRREST - Effectiveness of an Interactive Cognitive Support Tablet App in Reducing Deviations From Guidelines in the Management of Pediatric Cardiac Arrest: a Simulation-based Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04619498
- Acronym / sponsor ID
- PediAppRREST / BIRD191291
- Conditions
- Cardiac Arrest
- Keywords
- cardiac arrest, resuscitation, cognitive aid, mobile app, emergency medicine, simulation, pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Collaborators
- University of Florence, Catholic University of the Sacred Heart, Università degli Studi del Piemonte Orientale Amedeo Avogadro
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pediatric cardiac arrest (PCA) has a high mortality and morbidity. Its management is complex and often deviates from guideline recommendations leading to patients' worse clinical outcomes. A new tablet app, named PediAppRREST has been developed by our research group to support the management of PCA. The aim of the study is to evaluate the impact of the PediAppRREST app on the management of a PCA simulated scenario. The investigators have planned to conduct a multicenter, simulation-based, randomized control trial assessing the number of deviations (errors and delays) from international recommendations in PCA management. The hypothesis is that teams who use the PediAppRREST app as a cognitive aid will show fewer deviations from guidelines than teams who use a static paper-based cognitive aid (American Heart Association Pediatric Advanced Life Support pocket reference card) or no cognitive aid, during the management of a simulated PCA scenario.
Detailed description
AIMS
The primary aim of the study is to evaluate the effectiveness of a new tablet app, named PediAppRREST, in reducing deviations from guideline recommendations during pediatric cardiac arrest management.
The secondary aim is to assess the impact of the use of the app on performance and time to accomplish critical interventions for resuscitation, team leader's workload, cardiopulmonary resuscitation quality metrics and overall resuscitation team performance. Furthermore, the study will have the purpose to evaluate the usability of the app.
METHODS
PARTICIPANTS
Participants will be residents in Pediatrics, Emergency Medicine, and Anesthesiology-Intensive Care programs at four Italian University Hospitals (Padova, Firenze, Novara, and Roma). In order to be included in the study, residents must be BLS (Basic Life Support) or P-BLS (Pediatric-Basic Life Support) or PALS (Pediatric Advanced Life Support) or ALS (Advanced Life Support) or ACLS (Advanced Cardiac Life Support) certified, following the American Heart Association (AHA) or the European Resuscitation Council (ERC) recommendations. Additionally, to be eligible for the role of team leader residents must be PALS-certified according to AHA or ERC guidelines. Those residents who are unable to attend the simulation sessions because of maternity/paternity leave, personal/sick leave or training abroad, or who have participated in previous studies using the PediAppRREST app will not be eligible to participate in the trial.
STUDY DESIGN
This will be a multicenter, randomized controlled, three-parallel arm study, conducted in the setting of simulation. All teams, each consisting of three participants, will manage the same scenario of non-shockable pediatric cardiac arrest with the help of one confederate nurse who will act according to a script. Participants will be randomized to teams, and teams to interventions, using a 1:1:1 ratio. According to the allocation into one of three study arms, teams will use, or not use, a different PALS-related cognitive aid during the management of the scenario: 1) an intervention group using the tablet app PediAppRREST; or 2) a control group (CtrlPALS+) using the AHA-PALS pocket reference card; or 3) a control group (CtrlPALS-) not allowed to use any cognitive aid.
All the simulation scenarios will be video recorded, and two independent, previously trained reviewers will report actions performed by the teams and time to accomplish them. Outcomes will be subsequently assessed by two independent outcome assessors using data extracted by video reviewers.
OUTCOMES
The primary outcome of the study will be the number of deviations from AHA PALS guidelines recommendations during the management of pediatric cardiac arrest, defined as delays and errors according to a novel checklist, named c-DEV15plus, based on previously published guidelines, checklists and scoring systems/evaluation tools.
The secondary outcomes will be the performance of critical actions for resuscitation and the time to perform them, the usability of the app (measured by open-ended questions and one validated questionnaire: the System Usability Scale), the team leaders' workload (measured by the validated NASA-Task Load Index), the quality metrics of cardiopulmonary resuscitation (extracted by the manikin's software SkillReporter, Laerdal™) according to AHA guidelines, and the overall team resuscitation performance (measured by the validated Clinical Performance Tool).
SAMPLE SIZE CALCULATION
The investigators calculated the sample size on the basis of the results obtained during two previous studies: one observational simulation-based study and one pilot study conducted to test the app usability. Based on the preliminary results from these studies, using a single factor ANOVA model, 29 scenarios per each of the three groups (PediAppRREST, CtrlPALS+, CtrlPALS-) are necessary to detect a difference of at least 3.00 points on the c-DEV15plus scale using the Tukey-Kramer (Pairwise) multiple comparison procedure at a 5% significance level and 80% power. In consideration that some possible technical problems with video-recording or other study procedures could occur, the investigators aim to increase the recruitment of participating teams by 20% per arm, to compensate for loss of statistical power due to a potential insufficient sample size. Hence, the investigators plan to have 35 scenarios per arm, for a total of 105 scenarios, which will include overall 315 residents who will be divided in teams of three.
STATISTICAL ANALYSIS
The c-DEV15plus scale, the performance and time to accomplish specific resuscitation interventions, workload, overall team performance and cardiopulmonary resuscitation metrics will be compared between groups with one-way ANOVA model, followed by the Tukey-Kramer multiple comparisons adjustment procedure in case of statistical significance. The outcomes will also be analyzed with a linear mixed model considering the team as a cluster to evaluate the influence of participants' characteristics on the outcome. To take into account the correlation of the observations within a team, the investigators will specify an undetermined correlation matrix. In case of a not normal distribution of the model residuals, the investigators will proceed with a transformation in order to normalize the distribution.
CONFIDENTIALITY AND PRIVACY PROTECTION
A written informed consent to take part into the study will be obtained from each participant. To ensure that the data collected remains confidential, all data and videos will be stored on password protected and secured hard-disk drives, that will be stored in locked filing cabinets located at the Department of Women's and Children's health, University of Padova, Italy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized, controlled, three-parallel arm study
| Arm | Type | Receives |
|---|---|---|
| PediAppRREST app | Experimental | Device: PediAppRRESTThe teams assigned to the PediAppRREST arm will manage the simulated scenario of pediatric cardiac arrest using the new PediAppRREST tablet app as a cognitive aid. |
| CtrlPALS+ | Active comparator | Other: AHA-PALS pocket reference cardThe teams assigned to the CtrlPALS+ arm will manage the simulated scenario of pediatric cardiac arrest using the American Heart Association Pediatric Advanced Life Support (AHA-PALS) pocket reference card. |
| CtrlPALS- | No intervention | –The teams assigned to the CtrlPALS- arm will manage the simulated scenario of pediatric cardiac arrest using no PALS-related cognitive aids. |
Who may qualify
- Ages
- 24 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- to be attending a medical residency training program in Pediatrics, Anesthesiology-Intensive Care or Emergency Medicine
- to be BLS (Basic Life Support) or P-BLS (Pediatric-Basic Life Support) or PALS (Pediatric Advanced Life Suport) or ALS (Advanced Life Support) or ACLS (Advanced Cardiac Life Support) certified, following the American Heart Association (AHA) or the European Resuscitation Council (ERC) courses
- to give consent to participate to the study and to be video-recorded.
- Additionally, to be eligible for the role of team leader, residents must be PALS-certified according to AHA or ERC guidelines
Key exclusion criteria (2 listed)
- to be unable to attend the simulation sessions because of personal leave, maternity/paternity leave, sick leave or training abroad
- participation in previous studies using the PediAppRREST app
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PediAppRRESTPediAppRREST is a new audiovisual interactive app for tablets developed to support the management of pediatric cardiac arrest. It sequentially displays directions on recommended management interventions. It was specifically designed to guide the team leader to perform resuscitation interventions in the sequence/timing and modality reported by the American Heart Association Pediatric Advanced Life Support (AHA-PALS) guidelines. | Device | PediAppRREST app |
| AHA-PALS pocket reference cardIt is a 10 cm x 16.5 cm, full-color, 2-sided, 6-panel card that shows the American Heart Association Pediatric Advanced Life Support (AHA-PALS) treatment algorithms. By providing a quick reference tool, it serves as a cognitive aid for healthcare providers who either direct or participate in the management of pediatric respiratory and/or cardiovascular emergencies, including cardiac arrest. | Other | CtrlPALS+ |
Primary outcome
Deviations from American Heart Association Pediatric Advanced Life Support (AHA-PALS) guidelines
Time frame: Scenario will be video recorded and evaluated by two independent video reviewers. Outcome assessors will score teams' performance by means of the c-DEV15plus score using data extracted by video reviewers through study completion, an average of 15 months.
Deviations from AHA-PALS guidelines recommendations are defined as delays and errors according to a novel checklist we derived from a previously published checklist, denominated c-DEV (circulation-deviations), published by Wolfe et al. (2020), by integrating it with evidence-based guidelines, previously reported scoring tools and checklists. We named our new modified checklist c-DEV15plus (circulation-deviations 15 plus). It includes 15 items, which represent correct critical actions for pediatric resuscitation. Each item of the c-DEV15plus is scored either as 0, when the action is performed correctly and timely, as described in the item, or as 1, when the action is not undertaken, undertaken incorrectly, or with wrong timing. The sum of the points attributed to the items represents the c-DEV15plus total score, hence ranging from a minimum of 0 to a maximum of 15, with higher scores corresponding to a higher number of deviations from the guidelines and a worse performance.
34 secondary outcomes
Recognition of cardiac arrest (pulsenessness)
Time frame: Scenario will be video recorded and successively two independent video reviewers will assess the pulsessness recognition, through study completion, an average of 15 months.
Time to cardiac arrest (pulsenessness) recognition
Time frame: Scenario will be video recorded and successively two independent video reviewers will assess the time to pulselessness recognition, through study completion, an average of 15 months.
Performance of chest compressions
Time frame: Scenario will be video recorded and successively two independent video reviewers will assess the performance of chest compressions, through study completion, an average of 15 months.
Time to start chest compressions from arrest recognition
Time frame: Scenario will be video recorded and successively two independent video reviewers will assess the time to start chest compressions, through study completion, an average of 15 months.
Time to start chest compressions from the beginning of the scenario
Time frame: Scenario will be video recorded and successively two independent video reviewers will assess the time to start chest compressions, through study completion, an average of 15 months.
Performance of ventilation
Time frame: Scenario will be video recorded and successively two independent video reviewers will assess the start of ventilation, through study completion, an average of 15 months.
Time to start of ventilation from arrest recognition
Time frame: Scenario will be video recorded and successively two independent video reviewers will assess the time to start ventilation, through study completion, an average of 15 months.
Time to start of ventilation from the beginning of the scenario
Time frame: Scenario will be video recorded and successively two independent video reviewers will assess the time to start ventilation, through study completion, an average of 15 months.
Use a cardiopulmonary resuscitation board or a rigid surface underneath the manikin
Time frame: Scenario will be video recorded and successively two independent video reviewers will assess the use of a cardiopulmonary resuscitation board or a rigid surface underneath the manikin, through study completion, an average of 15 months.
Time to use a cardiopulmonary resuscitation board or a rigid surface underneath the manikin from arrest recognition
Time frame: Scenario will be video recorded and successively two independent video reviewers will assess the time to use a cardiopulmonary resuscitation board or a rigid surface underneath the manikin, through study completion, an average of 15 months.
Time to use a cardiopulmonary resuscitation board or a rigid surface underneath the manikin from the beginning of the scenario
Time frame: Scenario will be video recorded and successively two independent video reviewers will assess the time to use a cardiopulmonary resuscitation board or a rigid surface underneath the manikin, through study completion, an average of 15 months.
Call for emergency team help
Time frame: Scenario will be video recorded and successively two independent video reviewers will assess the call for emergency team help, through study completion, an average of 15 months.
Time to call for emergency team help from arrest recognition
Time frame: Scenario will be video recorded and successively two independent video reviewers will assess the time to call for emergency team help, through study completion, an average of 15 months.
Time to call for emergency team help from the beginning of the scenario
Time frame: Scenario will be video recorded and successively two independent video reviewers will assess the time to call for emergency team help, through study completion, an average of 15 months.
Use of electrocardiogram monitoring
Time frame: Scenario will be video recorded and successively two independent video reviewers will assess the use of electrocardiogram monitoring, through study completion, an average of 15 months.
Time to start electrocardiogram monitoring from arrest recognition
Time frame: Scenario will be video recorded and successively two independent video reviewers will assess the time to start electrocardiogram monitoring, through study completion, an average of 15 months.
Time to start electrocardiogram monitoring from the beginning of scenario
Time frame: Scenario will be video recorded and successively two independent video reviewers will assess the time to start electrocardiogram monitoring, through study completion, an average of 15 months.
Administration of a correct first epinephrine
Time frame: Scenario will be video recorded and successively two independent video reviewers will assess the correct administration of the first epinephrine, through study completion, an average of 15 months.
Time to first epinephrine administration from arrest recognition
Time frame: Scenario will be video recorded and successively two independent video reviewers will assess the time to the first epinephrine administration, through study completion, an average of 15 months.
Time to first epinephrine administration from the beginning of the scenario
Time frame: Scenario will be video recorded and successively two independent video reviewers will assess the time to the first epinephrine administration, through study completion, an average of 15 months.
Administration of a correct second epinephrine
Time frame: Scenario will be video recorded and successively two independent video reviewers will assess the correct administration of the second epinephrine dose, through study completion, an average of 15 months.
Time to second epinephrine administration from arrest recognition
Time frame: Scenario will be video recorded and successively two independent video reviewers will assess the time to second epinephrine administration, through study completion, an average of 15 months.
Time to second epinephrine administration from the beginning of the scenario
Time frame: Scenario will be video recorded and successively two independent video reviewers will assess the time to second epinephrine administration, through study completion, an average of 15 months.
Treatment of reversible causes
Time frame: Scenario will be video recorded and successively two independent video reviewers will assess the correct treatment of reversible causes, through study completion, an average of 15 months.
Time to treatment of reversible causes from arrest recognition
Time frame: Scenario will be video recorded and successively two independent video reviewers will assess the time to treatment of reversible causes, through study completion, an average of 15 months.
Time to treatment of reversible causes from the beginning of the scenario
Time frame: Scenario will be video recorded and successively two independent video reviewers will assess the time to treatment of reversible causes, through study completion, an average of 15 months.
Usability of the app - System Usability Scale
Time frame: Questionnaires will be completed after each simulated scenario through study completion, an average of 15 months.
Usability of the app - Open-ended questions
Time frame: Questionnaires will be completed after each simulated scenario through study completion, an average of 15 months.
Team leaders' workload
Time frame: Questionnaires will be completed by team leaders after each simulated scenario through study completion, an average of 15 months.
Cardiopulmonary resuscitation (CPR) quality - Mean chest compression rate
Time frame: CPR quality data will be extracted by the manikin's software after each simulated scenario, through study completion, an average of 15 months.
Cardiopulmonary resuscitation (CPR) quality metrics - Mean chest compression depth
Time frame: CPR quality data will be extracted by the manikin's software after each simulated scenario, through study completion, an average of 15 months.
Cardiopulmonary resuscitation (CPR) quality metrics - Compression depth correctness
Time frame: CPR quality data will be extracted by the manikin's software after each simulated scenario, through study completion, an average of 15 months.
Cardiopulmonary resuscitation (CPR) quality metrics - Chest compressions fraction
Time frame: CPR quality data will be extracted by the manikin's software after each simulated scenario, through study completion, an average of 15 months.
Team resuscitation performance
Time frame: Scenario will be video recorded and successively evaluated by two independent video reviewers. Outcome assessors will score teams' performance by means of CPT using data extracted by video reviewers, through study completion, an average of 15 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Background: PubMed 32788142Corazza F, Snijders D, Arpone M, Stritoni V, Martinolli F, Daverio M, Losi MG, Soldi L, Tesauri F, Da Dalt L, Bressan S. Development and Usability of a Novel Interactive Tablet App (PediAppRREST) to Support the Management of Pediatric Cardiac Arrest: Pilot High-Fidelity Simulation-Based Study. JMIR Mhealth Uhealth. 2020 Oct 1;8(10):e19070. doi: 10.2196/19070.
- Background: PubMed 32057946Wolfe HA, Morgan RW, Zhang B, Topjian AA, Fink EL, Berg RA, Nadkarni VM, Nishisaki A, Mensinger J, Sutton RM; American Heart Association's Get With the Guidelines-Resuscitation Investigator. Deviations from AHA guidelines during pediatric cardiopulmonary resuscitation are associated with decreased event survival. Resuscitation. 2020 Apr;149:89-99. doi: 10.1016/j.resuscitation.2020.01.035. Epub 2020 Feb 11.
- Derived from this study: PubMed 37535352Corazza F, Arpone M, Tardini G, Stritoni V, Mormando G, Graziano A, Navalesi P, Fiorese E, Portalone S, De Luca M, Binotti M, Tortorolo L, Salvadei S, Nucci A, Monzani A, Genoni G, Bazo M, Cheng A, Frigo AC, Da Dalt L, Bressan S. Effectiveness of a Novel Tablet Application in Reducing Guideline Deviations During Pediatric Cardiac Arrest: A Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2327272. doi: 10.1001/jamanetworkopen.2023.27272.
- Derived from this study: PubMed 34321297Corazza F, Arpone M, Snijders D, Cheng A, Stritoni V, Ingrassia PL, De Luca M, Tortorolo L, Frigo AC, Da Dalt L, Bressan S. PediAppRREST: effectiveness of an interactive cognitive support tablet app in reducing deviations from guidelines in the management of paediatric cardiac arrest: protocol for a simulation-based randomised controlled trial. BMJ Open. 2021 Jul 28;11(7):e047208. doi: 10.1136/bmjopen-2020-047208.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Bressan, MD, PhD principal investigator
University of Padova
Francesco Corazza, MD principal investigator
University of Padova
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PediAppRREST and AHA-PALS pocket reference card in people with Cardiac Arrest, run by University of Padova at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deviations from American Heart Association Pediatric Advanced Life Support (AHA-PALS) guidelines (time frame: Scenario will be video recorded and evaluated by two independent video reviewers. Outcome assessors will score teams' performance by means of the c-DEV15plus score using data extracted by video reviewers through study completion, an average of 15 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04619498, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.