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Cardiopulmonary ArrestInterFACENCT04464603

Impact of a mHealth Supportive Tool on Cardiopulmonary Resuscitation' Situational Awareness

A study testing InterFACE (mHealth tool) and Conventional methods in people with Cardiopulmonary Arrest and Pediatric ALL, run by Pediatric Clinical Research Platform at 1 site in Switzerland.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study will be a prospective, single-center, randomized controlled trial in a tertiary pediatric emergency department with two parallel groups of voluntary pediatric physicians and nurses. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
InterFACE (mHealth tool) and Conventional methods
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteSwitzerland
Study dates
1 Nov 2025to 31 Jan 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Any physician performing a fellowship in the pediatric emergency department.
  • Any postgraduate residents pursuing a <5 years residency in pediatrics.
  • To be registered nurses from the PED.
  • To have previously completed a standardized 15-min introductory course on the use of the InterFACE tool dispensed by the study investigators.
  • Participation agreement

Who cannot join

  • To have not undergone the standardized 15-min introductory course on the use of the InterFACE tool dispensed by the study investigators.
  • Participation to a simulation in the past month is an exclusion criterion to avoid a recent training effect.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Johan N Siebert, MD contact

+41 79 553 40 72

Johan.Siebert@hcuge.ch

Frederic Ehrler, PhD contact

Frederic.Ehrler@hcuge.ch

Switzerland1 site
  • Geneva Children's Hospital, Geneva University Hospitals

    Geneva, Canton of Geneva, 1205

    Johan N Siebert, MD, +41 (0)22 372 45 55, Johan.Siebert@hcuge.ch

    Frederic Ehrler, PhD, +41 (0)22 372 86 97, Frederic.Ehrler@hcuge.ch

Other trials in Switzerland

About this study

Official title: Impact of a Shared Decision-making mHealth Tool on Caregivers' Team Situational Awareness, Communication Effectiveness, and Performance During Pediatric Cardiopulmonary Resuscitation: a Randomized Controlled Trial

This study will be a prospective, single-center, randomized controlled trial in a tertiary pediatric emergency department with two parallel groups of voluntary pediatric physicians and nurses. The impact of a mHealth supportive tool will be compared with conventional communication methods on situational awareness, leadership, team communication effectiveness and performance during standardized, simulation-based, pediatric in-hospital cardiac arrest scenario using a high-fidelity manikin. Thirty-six participants will be randomized (1:1). The primary endpoint is the situational awareness score measured with the situation awareness global assessment technique (SAGAT) instrument.

Read the detailed description

Effective team communication, coordination, and situational awareness by cardiac arrest team members are critical components to deliver optimal cardiopulmonary arrest resuscitation care. But the complexity of care during cardiopulmonary resuscitation (CPR), numerous providers involved, miscommunication, and exogenous factors can all contribute to wresting patients care, thus jeopardizing their survival. The aim of this trial is to investigate whether a mHealth supportive tool (the interconnected and focused mobile apps on patient care environment [InterFACE]) developed as a collaborative platform to support CPR providers in real-time and share patient-centered information would increase situational awareness during pediatric CPR and improve team communication and performance.

This clinical trial will be a prospective, single-center, randomized controlled trial in a tertiary pediatric emergency department (>33,000 consultations/year) with two parallel groups of voluntary pediatric emergency fellows, residents and nurses.

Situational Awareness (SA), leadership, communication skills and team performance will be compared using a shared mHealth supportive tool ("InterFACE", group A) or conventional team interactions (group B) during standardized simulation-based pediatric in-hospital cardiac arrest scenario (p-IHCA) and life-threatening trauma scenarios using a high-fidelity manikin. InterFACE consists of a dual, interconnected mHealth tool composed primarily of a mobile device app, namely "Guiding Pad" (PMID: 32292179), interfaced to a remote large liquid crystal display (LCD) screen installed in the shock room and situated above the patient's head.

Thirty-six participants will be randomized 1:1 (each team will comprise six participants, i.e. a total of 6 teams). The teams will be asked to perform consecutively two 20-min highly realistic, scripted CPR scenarios on a high-fidelity WiFi manikin (Laerdal SimBaby, Laerdal Medical, Stavanger, Norway) using either the mHealth tool or conventional methods. The scenarios will be standardized to strictly follow the 2018 AHA algorithms and the 2018 ATLS guidelines.

In this simulation-based study, each team member will answer the SAGAT queries specific to their roles. Leadership will be measured with the resuscitation team leader evaluation (RTLE) instrument. Effective teamwork and communication will be measured with the team emergency assessment measure (TEAM) instrument. The SUS instruments will be used to measure the usability of the mHealth tool. For the trauma scenario, the modified non-technical skills scale for trauma (T-NOTECHS) will not be used due to the serious risk of assessment bias with this instrument, as emphasized by the consensus-based standards for the selection of health measurement instruments (COSMIN).

Data collection will be carried out by the responsive simulator detectors (Laerdal SimBaby) and the two GoPro video cameras. The set-up of both cameras will be standardized. The recorded videos will be safely stored in duplicate on secured hard-disk drives in a locked room. As all scenarios will be fully video-recorded, all actions, communications and interactions will be recorded and later scored by two raters to allow outcomes analysis and for the calculation of interrater reliability. All actions performed with the app will be automatically saved locally in log files for further analysis. This study offers the major advantage to observe a unique 60-min period per resuscitation team. Therefore, neither follow-up nor retention plans will be necessary. The resuscitation algorithm is highly standardized and deviation from the algorithm is a parameter of interest in this study. Data collection will be carried out using the REDCap database (REDCap, Vanderbilt University, Nashville, TN, USA).

This clinical trial will assess the impact of a collaborative mHealth tool to increase situational awareness and effective team communication during in-hospital pediatric resuscitation. As research in this area is scarce, the results generated from this study will be of great importance and may be sufficient to change and improve in-hospital pediatric emergency care practice in an era of communication technologies.

Being tested
InterFACE (mHealth tool), Conventional methods
Keywords
Information technologies, Situation Awareness, Teamwork, Leadership, Mobile applications, Biomedical Technology
Medical subject headings
Heart Arrest, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InterFACE (mHealth tool)Device

    Participants will be asked to perform consecutively two 20-min highly realistic, scripted CPR scenarios (first: PALS-based scenario, second: ATLS-based scenario) on a high-fidelity WiFi manikin.

    Within each scenario, 3 separate "freeze" periods will occur at random points in time to assess the shared and complementary Situation Awareness of each team member individually regarding the CPR in progress at that exact moment in time. The scenarios will be standardized to strictly follow the 2018 AHA algorithms and the 2018 ATLS guidelines.

    Both scenarios will be completed in the same order and the procedure will be standardized across all teams to follow the same chronological progression and range of difficulty in order to ensure that each participant is exposed to exactly the same case, with similar challenges in technical and non-technical skills.

    Participants allocated to Arm A will not be allowed to use any other cognitive support.

  • Conventional methodsOther

    Participants will be asked to perform consecutively two 20-min scripted CPR scenarios (PALS and ATLS-based scenario) on a high-fidelity WiFi manikin.

    Within each scenario, 3 separate "freeze" periods will occur at random points in time to assess the shared and complementary Situation Awareness of each team member individually regarding the CPR in progress at that exact moment in time. The scenarios will be standardized to strictly follow the 2018 AHA algorithms and 2018 ATLS guidelines.

    Both scenarios will be completed in the same order and the procedure will be standardized across all teams to follow the same chronological progression and range of difficulty in order to ensure that each participant is exposed to exactly the same case, with similar challenges in technical and non-technical skills.

    Participants allocated to group B will be allowed to use the PALS pocket reference cards and a conventional calculator, but not any other cognitive support or mHealth tool.

Study groups in NCT04464603
Study groupRoleWhat they receive
Arm A (InterFACE)ExperimentalParticipants that will use the mHeath InterFACE tool during the simulation-based pediatric scenario. Each participant will have to do 2 consecutive scenarios (PALS, ATLS).
Receives: Device: InterFACE (mHealth tool)
Arm B (Conventional methods)Active comparatorParticipants that will use conventional methods during the simulation-based pediatric scenario. Each participant will have to do 2 consecutive scenarios (PALS, ATLS).
Receives: Other: Conventional methods

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Situational awareness

    Situational awareness (SA) will be measured using retrospective video review by the SA global assessment technique (SAGAT) instrument for each scenario, both as the score of each SAGAT at an individual level and at the team level (given as the sum of individual SAGAT scores for each team; TSAGAT). The SAGAT responses for categorical variables will be scored as either correct (1) or incorrect (0) by two of the investigators, irrespective of whether they agreed completely with the true answer. For numerical responses, answers will be considered correct based upon a 10% pre-defined tolerance range settled by the research investigators around the true value. The scores will be expressed as percentages in conjunction with absolute n/N values. Higher SA scores will denote higher SA.

    Measured: 40 minutes

Secondary outcomes (7)
  1. Resuscitation team leader evaluation

    Leadership will be measured using the 12-item RTLE instrument developed by Grant et al. that encompasses four leadership concepts: (1) the physical and verbal leader's position; (2) communication and delegating skills; (3) ability to assess, adapt and anticipate; and (4) ability to ask for internal and external help. This instrument comprises 12 items rated on a 4-point Likert scale from 0 (not performed) to 3 (performed well) to score leadership and communication skills. A not applicable (N/A) category is also available for those items not relevant to the scenario. For the purpose of this trial, items 1 and 12 will be removed as the leader will be clearly identified from the beginning of the scenario and teams will not be advised to ask for external help. Therefore, the total item score will range from 0 to 30.

    Measured: 40 minutes

  2. Team Emergency Assessment Measure

    Teamwork performance will be measured using the 11-item Team Emergency Assessment Measure (TEAM) tool that stands out as the most valid and reliable instrument to use in emergency departments. TEAM comprises 11 items rated on a 5-point Likert scale from 0 (never/hardly) to 4 (always/nearly always), which are summed up into a total item score ranging from 0 to 44. The final score obtained allows to assess the performance of the emergency medical team based on three categories: leadership (items 1 and 2); teamwork (items 3 to 9); and task management (items 10 and 11). Items 8 and 9 relate to SA perception and projection, respectively. Furthermore, the team's overall performance is rated through a twelfth item on a global rating scale of 1 to 10 (higher score denotes better performance).

    Measured: 40 minutes

  3. Medication dosage errors

    Errors in drug dose administration (in milligrams) will be measured in each allocation group as a deviation from the 2018 AHA PALS cardiac arrest algorithm. An emergency medication dose administration error is defined as a deviation from the correct weight dose of more than 10%. Errors will be also measured both as the percentage deviation from the amount of delivered drug compared with the correct weight dose as prescribed by the physician and the absolute deviations from that dose.

    Moreover, defibrillations (in Joules) and the number of shocks will be also measured during the first scenario. For the second scenario, errors in fluid resuscitation volumes (in milliliters) will be measured as a deviation from the 2018 ATLS guidelines.

    Measured: 40 minutes

  4. Time to critical life-saving maneuvers

    The elapsed time in seconds between the end of the clinical statement by the study investigator to: (1) cardiac arrest or hypotensive shock recognition; (2) initiation of chest compression; (3) time to each defibrillation attempt; (4) time to administration of intravenous drugs, volume expansion with 0.9% sodium chloride or blood transfusion; and (5) time interval between defibrillation attempts will be measured.

    Measured: 40 minutes

  5. System usability scale

    Usability testing of the mHealth tool InterFACE will be assessed using the System Usability Scale (SUS) instrument. The SUS instrument consists of a 10-item questionnaire with five response options for each item, based on their level of agreement ranging from 1 (strongly disagree) to 5 (strongly agree). For odd-numbered statements 1, 3, 5, 7, 9 (positively-worded items), the score contribution is equal to the scale position minus 1. For even-numbered statements 2, 4, 6, 8, 10 (negatively-worded items), the score contribution is equal to 5 minus the scale position. Each score contribution will fall within the range of 0 to 4. The participant's scores for each item are then added up together and multiplied by 2.5 to convert the original scores of 0-40 to 0-100.

    Measured: 10 minutes

  6. Team effectiveness

    Team effectiveness will be also measured as the time spent by the team to achieve the pre-designed goals set out by the AHA for the PALS course and the American College of Surgeons for the ATLS course.

    Measured: 40 minutes

  7. Stress perceived and satisfaction

    A 3-item questionnaire using a 10-point Likert scale will be provided to the participants to measure their perceived stress and satisfaction about the preparation method used during the resuscitation scenario.

    The questionnaire measures (1) the stress perceived before the scenario starts (On a scale from 1 to 10, how stressed are you now?), (2) the overall stress perceived at the end of the scenario (On a scale of 1 to 10, how stressed [maximum reached] were you during the scenario?), and (3) the satisfaction about the supportive method used during the resuscitation scenario (On a scale of 1 to 10, how satisfied were you with your supported experience?)

    Scale ranges: from 0 (minimum score) to 10 (maximum score), increments are integers between 0 to 10. For stress, higher values represent a worse score, whereas for satisfaction higher values represent a better score. No subscales will be combined.

    Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2020
  2. Study start1 Nov 2025 (estimated)
  3. Primary completion31 Jan 2026 (estimated)
  4. Study completion31 Jan 2026 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
A prospective, single center, randomized controlled trial
Masking
Single blind
Who is masked
Participant
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04464603
Sponsor's protocol ID
InterFACE
Acronym
InterFACE
Status last verified
Aug 2025
First submitted
2 Jul 2020
Last updated
19 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD will be deidentified and the study investigators will house the data locally on secure hard disk drives at the Geneva Children's Hospital. The datasets used or analyzed during the current trial will be available from the corresponding author upon reasonable request. Only deidentified/anonymized data will be shared.

Publications

  • Siebert JN, Lacroix L, Cantais A, Manzano S, Ehrler F. The Impact of a Tablet App on Adherence to American Heart Association Guidelines During Simulated Pediatric Cardiopulmonary Resuscitation: Randomized Controlled Trial. J Med Internet Res. 2020 May 27;22(5):e17792. doi: 10.2196/17792.

    PubMed 32292179
  • Ehrler F, Sahyoun C, Manzano S, Sanchez O, Gervaix A, Lovis C, Courvoisier DS, Lacroix L, Siebert JN. Impact of a shared decision-making mHealth tool on caregivers' team situational awareness, communication effectiveness, and performance during pediatric cardiopulmonary resuscitation: study protocol of a cluster randomized controlled trial. Trials. 2021 Apr 13;22(1):277. doi: 10.1186/s13063-021-05170-3.

    PubMed 33849611

Questions about this trial

What is this clinical trial studying?

A study testing InterFACE (mHealth tool) and Conventional methods in people with Cardiopulmonary Arrest and Pediatric ALL, run by Pediatric Clinical Research Platform at 1 site in Switzerland.

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 5 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: opening soon, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Johan N Siebert, MD (+41 79 553 40 72, Johan.Siebert@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Situational awareness (time frame: 40 minutes). 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 NCT04464603, which also lists 2 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 19 Aug 2025.

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