Cardiac ArrestNCT03616938
Infant Chest Compression
A study testing Cardiopulmonary resuscitation in people with Cardiac Arrest and Infant, run by Łukasz Szarpak at 1 site in Poland.
Trial summary
our aim was to quantitatively compare the quality of chest-compression of the new two thumb chest compression (nTTT) versus the current standard techniques: two finger technique (TFT), two thumb technique (TTHT) as defined by systolic-, diastolic-, mean arterial- and pulse-pressures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest, Infant, Simulation
- What is being tested?
- Cardiopulmonary resuscitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 sitePoland
- Study dates
- 28 Jul 2018to Aug 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- nurses
- give voluntary consent to participate in the study
Who cannot join
- not meet the above criteria
- wrist or low back diseases
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Lazarski University
Warsaw, Masovian Voivodeship, 02-662
Lukasz Szarpak, 500186225, lukasz.szarpak@gmail.com
About this study
Official title: Impact of Newly Infant Chest Compression Technique on Hemodynamic Effect During CPR: A Multicenter Randomized Crossover Experimental Study
our aim was to quantitatively compare the quality of chest-compression of the new two thumb chest compression (nTTT) versus the current standard techniques: two finger technique (TFT), two thumb technique (TTHT) as defined by systolic-, diastolic-, mean arterial- and pulse-pressures. Our hypothesis is that nTTT generates higher arterial blood pressures compared to the established TFT and TTHT in an infant manikin model.
Read the detailed description
To simulate the scenario of infant CPR, an ALS Baby trainer manikin (Laerdal Medical, Stavanger, Norway) simulating a 3-month-old infant. The manikin was connected with a fixed-volume arterial system attached to a monitor (Draeger Infinity® Delta; Draegerwerk AG \& Co. KGaA, Luebeck, Germany) via an arterial pressure transducer (Edward Lifesciences: TruWave Disposable Pressure Transducer; Irvine, CA, USA). The arterial circuit composed of a 50-mL bag of normal saline solution (air removed) attached to the manikin chest plate and connected to the transducer with a 20-gauge intravenous catheter and tubing. The manikin was placed on a high adjustable hospital stretcher. The bed was leveled to the iliac crest of each rescuer for standardization. The manikin was previously intubated and ventilation was performed using a resuscitator bag.
- Conditions
- Cardiac Arrest, Infant, Simulation
- Being tested
- Cardiopulmonary resuscitation
- Keywords
- cardiopulmonary resuscitation, chest compression, medical simulation, randomization, quality
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary resuscitationProcedure or surgery
2-min cycle of cardiopulmonary resuscitation accorind to the American Heart Association 2015 guidelines
| Study group | Role | What they receive |
|---|---|---|
| the two finger chest compression technique | Experimental | Two finger technique (TFT): the pediatric thorax is compressed with the tips of two fingers and is recommended for lone rescuer during infant cardiopulmonary resuscitation by international resuscitation guidelines Receives: Procedure: Cardiopulmonary resuscitation |
| the two thumb chest compression technique | Experimental | Two thumb technique (TTHT): the two thumbs of the rescuer are placed over the lower third of the sternum, with the fingers encircling the torso and supporting the back. This technique is recommended for two rescuers during infant CPR by international CPR guidelines Receives: Procedure: Cardiopulmonary resuscitation |
| the new two thumb chest compression technique | Experimental | 'new two-thumb technique' (nTTT): this technique consists in using two thumbs directed at the angle of 90° to the chest while closing the fingers of both hands in a fist Receives: Procedure: Cardiopulmonary resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
systolic blood pressure (SBP)
The manikin was connected with a fixed-volume arterial system attached to a monitor (Draeger Infinity® Delta; Draegerwerk AG \& Co. KGaA, Luebeck, Germany) via an arterial pressure transducer (Edward Lifesciences: TruWave Disposable Pressure Transducer; Irvine, CA, USA). The arterial circuit composed of a 50-mL bag of normal saline solution (air removed) attached to the manikin chest plate and connected to the transducer with a 20-gauge intravenous catheter and tubing.
Measured: 1 day
Secondary outcomes (2)
diastolic blood pressure (DBP)
The manikin was connected with a fixed-volume arterial system attached to a monitor (Draeger Infinity® Delta; Draegerwerk AG \& Co. KGaA, Luebeck, Germany) via an arterial pressure transducer (Edward Lifesciences: TruWave Disposable Pressure Transducer; Irvine, CA, USA). The arterial circuit composed of a 50-mL bag of normal saline solution (air removed) attached to the manikin chest plate and connected to the transducer with a 20-gauge intravenous catheter and tubing.
Measured: 1 day
mean arterial pressure (MAP)
The manikin was connected with a fixed-volume arterial system attached to a monitor (Draeger Infinity® Delta; Draegerwerk AG \& Co. KGaA, Luebeck, Germany) via an arterial pressure transducer (Edward Lifesciences: TruWave Disposable Pressure Transducer; Irvine, CA, USA). The arterial circuit composed of a 50-mL bag of normal saline solution (air removed) attached to the manikin chest plate and connected to the transducer with a 20-gauge intravenous catheter and tubing.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start28 Jul 2018
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Łukasz Szarpak
- Sponsor type
- University, hospital or other
- Collaborators
- Wroclaw Medical University
- Responsible party
- Sponsor-investigator, Łukasz Szarpak, Lazarski University
- Investigators
- Lukasz Szarpak, PhD, Study director, Lazarski University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616938
- Sponsor's protocol ID
- NLS_2018_UL
- Status last verified
- Aug 2018
- First submitted
- 31 Jul 2018
- Last updated
- 6 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be available from the principal investigator
Publications
Smereka J, Szarpak L, Ladny JR, Rodriguez-Nunez A, Ruetzler K. A Novel Method of Newborn Chest Compression: A Randomized Crossover Simulation Study. Front Pediatr. 2018 May 29;6:159. doi: 10.3389/fped.2018.00159. eCollection 2018.
PubMed 29896467Ladny JR, Smereka J, Rodriguez-Nunez A, Leung S, Ruetzler K, Szarpak L. Is there any alternative to standard chest compression techniques in infants? A randomized manikin trial of the new "2-thumb-fist" option. Medicine (Baltimore). 2018 Feb;97(5):e9386. doi: 10.1097/MD.0000000000009386.
PubMed 29384839Smereka J, Szarpak L, Smereka A, Leung S, Ruetzler K. Evaluation of new two-thumb chest compression technique for infant CPR performed by novice physicians. A randomized, crossover, manikin trial. Am J Emerg Med. 2017 Apr;35(4):604-609. doi: 10.1016/j.ajem.2016.12.045. Epub 2016 Dec 19.
PubMed 28040386
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Newly Infant Chest Compression Technique on Hemodynamic Effect During CPR: A Multicenter Randomized Crossover Experimental Study
- ClinicalTrials.gov ID
- NCT03616938
- Acronym / sponsor ID
- NLS_2018_UL
- Conditions
- Cardiac Arrest, Infant, Simulation
- Keywords
- cardiopulmonary resuscitation, chest compression, medical simulation, randomization, quality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Łukasz SzarpakUniversity, hospital or other
- Collaborators
- Wroclaw Medical University
- Study start
- 28 Jul 2018 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 6 Aug 2018 (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.
our aim was to quantitatively compare the quality of chest-compression of the new two thumb chest compression (nTTT) versus the current standard techniques: two finger technique (TFT), two thumb technique (TTHT) as defined by systolic-, diastolic-, mean arterial- and pulse-pressures. Our hypothesis is that nTTT generates higher arterial blood pressures compared to the established TFT and TTHT in an infant manikin model.
Detailed description
To simulate the scenario of infant CPR, an ALS Baby trainer manikin (Laerdal Medical, Stavanger, Norway) simulating a 3-month-old infant. The manikin was connected with a fixed-volume arterial system attached to a monitor (Draeger Infinity® Delta; Draegerwerk AG \& Co. KGaA, Luebeck, Germany) via an arterial pressure transducer (Edward Lifesciences: TruWave Disposable Pressure Transducer; Irvine, CA, USA). The arterial circuit composed of a 50-mL bag of normal saline solution (air removed) attached to the manikin chest plate and connected to the transducer with a 20-gauge intravenous catheter and tubing. The manikin was placed on a high adjustable hospital stretcher. The bed was leveled to the iliac crest of each rescuer for standardization. The manikin was previously intubated and ventilation was performed using a resuscitator bag.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| the two finger chest compression technique | Experimental | Procedure: Cardiopulmonary resuscitationTwo finger technique (TFT): the pediatric thorax is compressed with the tips of two fingers and is recommended for lone rescuer during infant cardiopulmonary resuscitation by international resuscitation guidelines |
| the two thumb chest compression technique | Experimental | Procedure: Cardiopulmonary resuscitationTwo thumb technique (TTHT): the two thumbs of the rescuer are placed over the lower third of the sternum, with the fingers encircling the torso and supporting the back. This technique is recommended for two rescuers during infant CPR by international CPR guidelines |
| the new two thumb chest compression technique | Experimental | Procedure: Cardiopulmonary resuscitation'new two-thumb technique' (nTTT): this technique consists in using two thumbs directed at the angle of 90° to the chest while closing the fingers of both hands in a fist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- nurses
- give voluntary consent to participate in the study
Key exclusion criteria (2 listed)
- not meet the above criteria
- wrist or low back diseases
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 |
|---|---|---|
| Cardiopulmonary resuscitation2-min cycle of cardiopulmonary resuscitation accorind to the American Heart Association 2015 guidelines | Procedure or surgery | the new two thumb chest compression technique, the two finger chest compression technique, the two thumb chest compression technique |
Primary outcome
systolic blood pressure (SBP)
Time frame: 1 day
The manikin was connected with a fixed-volume arterial system attached to a monitor (Draeger Infinity® Delta; Draegerwerk AG \& Co. KGaA, Luebeck, Germany) via an arterial pressure transducer (Edward Lifesciences: TruWave Disposable Pressure Transducer; Irvine, CA, USA). The arterial circuit composed of a 50-mL bag of normal saline solution (air removed) attached to the manikin chest plate and connected to the transducer with a 20-gauge intravenous catheter and tubing.
2 secondary outcomes
diastolic blood pressure (DBP)
Time frame: 1 day
mean arterial pressure (MAP)
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
- Background: PubMed 29896467Smereka J, Szarpak L, Ladny JR, Rodriguez-Nunez A, Ruetzler K. A Novel Method of Newborn Chest Compression: A Randomized Crossover Simulation Study. Front Pediatr. 2018 May 29;6:159. doi: 10.3389/fped.2018.00159. eCollection 2018.
- Background: PubMed 29384839Ladny JR, Smereka J, Rodriguez-Nunez A, Leung S, Ruetzler K, Szarpak L. Is there any alternative to standard chest compression techniques in infants? A randomized manikin trial of the new "2-thumb-fist" option. Medicine (Baltimore). 2018 Feb;97(5):e9386. doi: 10.1097/MD.0000000000009386.
- Background: PubMed 28040386Smereka J, Szarpak L, Smereka A, Leung S, Ruetzler K. Evaluation of new two-thumb chest compression technique for infant CPR performed by novice physicians. A randomized, crossover, manikin trial. Am J Emerg Med. 2017 Apr;35(4):604-609. doi: 10.1016/j.ajem.2016.12.045. Epub 2016 Dec 19.
- Individual participant dataSharing planned: Undecided. Data will be available from the principal investigator
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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.
Lukasz Szarpak, PhD study director
Lazarski University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiopulmonary resuscitation in people with Cardiac Arrest and Infant, run by Łukasz Szarpak at 1 site in Poland.
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 2 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: status not confirmed, as of the sponsor's last update on 6 Aug 2018. 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lukasz Szarpak, PhD (500186225, lukasz.szarpak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
systolic blood pressure (SBP) (time frame: 1 day). 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 NCT03616938, which also lists 3 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 6 Aug 2018.