Cardiac ArrestNCT04736446
Continuous Compressions With Asynchronous Ventilations Using I-gel Device Versus 30:2 Approach During Simulated OHCA
A study testing I-gel® supraglottic device and Face mask ventilation in people with Cardiac Arrest and Cardiopulmonary Arrest, run by Geneve TEAM Ambulances at 1 site in Switzerland.
Trial summary
Paramedics and EMT will be recruited among four Emergency Medical Services (EMS) in Switzerland to manage a 10-minutes simulation-based adult out-of-hospital cardiac arrest scenario in teams of two. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest, Cardiopulmonary Arrest, Emergency Medical Services
- What is being tested?
- I-gel® supraglottic device and Face mask ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Feb 2021to 18 May 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- To be a registered paramedic or EMT
- To have previously completed the 20-minute workshop on how using the device by on of the study investigators
- To have previously completed the 20-minute self-training session following a video recorded by the study investigators
- Participation agreement
Who cannot join
- Member of the study investigators
- To have not undergone the 20-minute workshop
- To have not watch the video
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Manual Chest Compressions With Asynchronous Ventilations Using the I-gel Device Versus 30:2 Current Practice Approach With Face Mask Ventilations During Simulated OHCA: Manikin Multicentre Randomised Controlled Trial
Paramedics and EMT will be recruited among four Emergency Medical Services (EMS) in Switzerland to manage a 10-minutes simulation-based adult out-of-hospital cardiac arrest scenario in teams of two. Depending on randomization, each team will manage the scenario according either to their current approach (30 compressions with 2 bag-mask ventilations), or to the experimental approach (continuous compressions since the start of CPR except for rhythm analysis and shock delivering, with early insertion of an i-gel® device to deliver asynchronous ventilations). The main hypothesis is that early insertion of i-gel could improve CCF during out-of-hospital cardiac arrest, with a reasonable time to first effective ventilation.
Read the detailed description
Pre-scenario standardized workshop:
First, information about the study will be given and participants' questions are answered. Written consent will be obtained and the first part of the questionnaire individually completed. Participants will be told that the resuscitation scenario will be stopped after 10 minutes, independently of their actions and that no feedback will be given.
Then, the use of i-gel® device use will be taught by one of the investigators (LSt) in accordance with Peyton's approach because this approach has shown superiority, and based on a standard operating procedure created by study investigators following manufacturer's instructions:
- The instructor performs a complete insertion sequence in real-time without any comments;
- The instructor performs an insertion sequence with step-by-step explanations (description of key points);
- The learners guide the instructor step by step to perform the insertion;
- The learners do the complete insertion sequence then feedback could be given. They will perform this step a maximum of 3 times.
This workshop will last 20 minutes.
Self-managed training session:
After the workshop, each team will have 20 minutes to self-train the introduction of the device in the complete OHCA management sequence on a CPR manikin permitting airway management. They will be supported by a demonstration video, which they could use freely.
Resuscitation scenario:
When entering the study room, an overview of the characteristics of the simulation manikin and the use of the defibrillator will be given through a standardized video. The team will then be asked to perform a 10-minutes highly realistic adult CPR scenario on a high-fidelity WiFi manikin. The procedure will be standardized across all sites to ensure that each participant is exposed to exactly the same case, with similar challenges in decision-making and treatment provided on the same manikin. The uniform delivery of the scenario throughout the entire study will minimize confounders. The room will be exclusively devoted to the simulation to prevent unexpected interruptions or external stimuli.
The scenario will start with a clinical statement to recognize the life-threatening condition of the patient, given by one of the investigators as follows: " Here is Michael, a 50-years old who suddenly collapsed 10 minutes ago. He is now unconscious, pale and seems not breathing. The medical reinforcement is already underway and will be on site in about ten minutes. No first responder were dispatched to the scene and there is no bystander ". The team leader will be asked to reformulate this statement (closed-loop communication) to ensure comprehension. He will then open the following envelope of the stack. The opaque, sealed envelope will contain the approach they will have to apply: standard care or experimental approach. From this point on, there will be no more contact between the participants and the study team, except to stop the scenario.
If the participant checks the breathing, the patient will be apneic and pulse will be absent if checked. The first compression will be defined as T0. After placement of the pads, the defibrillator's display will show ventricular fibrillation (VF). All following rhythm analyses will show refractory VF, regardless of whether a shock is delivered. To increase simulation's fidelity, CPR waves will be displayed when compressions will be delivered. Participants will be able to obtain an intravenous access on first attempt. They should administer first 1 mg of epinephrine (at the earliest after the second shock), then a first-dose of amiodarone or lidocaine following local protocols (in accordance with the 2020 AHA cardiac arrest algorithm. The scenario will be stopped exactly 10 minutes after the first compression. There will be no feedback after the study period.
- Being tested
- I-gel® supraglottic device, Face mask ventilation
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-gel® supraglottic deviceDevice
Use of an i-gel® supraglottic device to deliver ventilations
Face mask ventilationDevice
Use of a face mask to deliver ventilations
| Study group | Role | What they receive |
|---|---|---|
| I-gel® group | Experimental | Continuous chest compressions from the start of the CPR with early i-gel® device insertion and asynchronous ventilations Receives: Device: I-gel® supraglottic device |
| Standard group | Other | Basic (standard) management by using a ratio of 30 compressions and 2 face mask ventilations Receives: Device: Face mask ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest compressions fraction (CCF) over the first 2 minutes of CPR
Proportion of time where compressions are performed during the first two minutes of the scenario
Measured: At the end of Cycle 1 (each cycle is 2 minutes)
Secondary outcomes (17)
CCF of second cycle
Proportion of time where compressions are performed during the following two minutes of the scenario
Measured: At the end of Cycle 2 (each cycle is 2 minutes)
CCF of third cycle
Proportion of time where compressions are performed during the following two minutes of the scenario
Measured: At the end of Cycle 3 (each cycle is 2 minutes)
CCF of fourth cycle
Proportion of time where compressions are performed during the following two minutes of the scenario
Measured: At the end of Cycle 4 (each cycle is 2 minutes)
CCF of fifth cycle
Proportion of time where compressions are performed during the following two minutes of the scenario
Measured: At the end of Cycle 5 (each cycle is 2 minutes)
Overall CCF
Proportion of time where compressions are performed during the entire scenario
Measured: 10 minutes of scenario
Chest compressions depth
Mean depth of compressions
Measured: 10 minutes of scenario
Proportions of compressions above, below and in the depth target
The depth target is 5 to 6 cm
Measured: 10 minutes of scenario
Chest compressions frequency
Mean frequency of compressions
Measured: 10 minutes of scenario
Proportions of compressions above, below and in the frequency target
The frequency target is 100 to 120 compressions by minute
Measured: 10 minutes of scenario
Time to first shock
Interval between start of compressions and delivering of first shock
Measured: 10 minutes of scenario
Time to first effective ventilation
Interval between start of compressions and delivering of first effective ventilation (defined as volume >300 ml)
Measured: 10 minutes of scenario
Ventilations volume
Mean volume of ventilations
Measured: 10 minutes of scenario
Proportions of ventilations above, below and in the volume target
The volume target is 300 to 700 ml
Measured: 10 minutes of scenario
User satisfaction assessed by a 5-point Likert scale ranging from "Not satisfied" to "Very satisfied"
User satisfaction regarding applied approach assessed on a 5-point Likert scale ranging from "Not satisfied" to "Very satisfied"
Measured: 10 minutes of scenario
Self-assessed cognitive load using a 9-point scale ranging from "Very, very low mentale effort" to "Very, very high mental effort"
Self-reported cognitive load during resuscitation scenario assessed using a 9-point symmetrical category scale which ranged from "Very, very low mental effort" (1) to "Very, very high mental effort" (9),
Measured: 10 minutes of scenario
Chest compression relaxation
Proportion of correct compressions (with less than 5 mm deviation from reference value)
Measured: 10 minutes of scenario
Number of delivered ventilations
Absolute number of delivered ventilations
Measured: 10 minutes of scenario
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start14 Feb 2021
- Primary completion18 May 2021
- Study completion18 May 2021
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
- Parallel groups
- Model description
- Prospective, multicenter, randomized, controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geneve TEAM Ambulances
- Sponsor type
- University, hospital or other
- Collaborators
- Service de protection et sauvetage Lausanne (SPSL), Emergency Medical Services, Switzerland, Ambulance Riviera, Emergency Medical Services, La Tour-de-Peilz, Switzerland, Compagnie d'Ambulances de l'Hôpital du Valais, Emergency Medical Services, Martigny, Switzerland, Swissrescue.ch, Website for Prehospital Healthcare Providers, Les Pontins, Switzerland, ESAMB - College of Higher Education in Ambulance Care, Geneva, Switzerland, STAR Ambulances, Emergency Medical Services, Épalinges, Vaud
- Responsible party
- Principal investigator, Stuby Loric, Geneve TEAM Ambulances
- Investigators
- Loric Stuby, Principal investigator, Genève TEAM Ambulances
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736446
- Sponsor's protocol ID
- CPR-1
- Status last verified
- Nov 2024
- First submitted
- 8 Jan 2021
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD will be deposited on Mendeley Data
Publications
Stuby L, Jampen L, Sierro J, Paus E, Spichiger T, Suppan L, Thurre D. Effect on Chest Compression Fraction of Continuous Manual Compressions with Asynchronous Ventilations Using an i-gel(R) versus 30:2 Approach during Simulated Out-of-Hospital Cardiac Arrest: Protocol for a Manikin Multicenter Randomized Controlled Trial. Healthcare (Basel). 2021 Mar 20;9(3):354. doi: 10.3390/healthcare9030354.
PubMed 33804664Stuby L, Suppan L, Jampen L, Thurre D. Impact of the Over-the-Head Position with a Supraglottic Airway Device on Chest Compression Depth and Rate: A Post Hoc Analysis of a Randomized Controlled Trial. Healthcare (Basel). 2022 Apr 13;10(4):718. doi: 10.3390/healthcare10040718.
PubMed 35455895Stuby L, Jampen L, Sierro J, Bergeron M, Paus E, Spichiger T, Suppan L, Thurre D. Effect of Early Supraglottic Airway Device Insertion on Chest Compression Fraction during Simulated Out-of-Hospital Cardiac Arrest: Randomised Controlled Trial. J Clin Med. 2021 Dec 31;11(1):217. doi: 10.3390/jcm11010217.
PubMed 35011958
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Manual Chest Compressions With Asynchronous Ventilations Using the I-gel Device Versus 30:2 Current Practice Approach With Face Mask Ventilations During Simulated OHCA: Manikin Multicentre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04736446
- Acronym / sponsor ID
- CPR-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Geneve TEAM AmbulancesUniversity, hospital or other
- Collaborators
- Service de protection et sauvetage Lausanne (SPSL), Emergency Medical Services, Switzerland, Ambulance Riviera, Emergency Medical Services, La Tour-de-Peilz, Switzerland, Compagnie d'Ambulances de l'Hôpital du Valais, Emergency Medical Services, Martigny, Switzerland, Swissrescue.ch, Website for Prehospital Healthcare Providers, Les Pontins, Switzerland, ESAMB - College of Higher Education in Ambulance Care, Geneva, Switzerland, STAR Ambulances, Emergency Medical Services, Épalinges, Vaud
- Study start
- 14 Feb 2021 (actual)
- Primary completion
- 18 May 2021 (actual)
- Study completion
- 18 May 2021 (actual)
- First posted
- 3 Feb 2021 (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.
Paramedics and EMT will be recruited among four Emergency Medical Services (EMS) in Switzerland to manage a 10-minutes simulation-based adult out-of-hospital cardiac arrest scenario in teams of two. Depending on randomization, each team will manage the scenario according either to their current approach (30 compressions with 2 bag-mask ventilations), or to the experimental approach (continuous compressions since the start of CPR except for rhythm analysis and shock delivering, with early insertion of an i-gel® device to deliver asynchronous ventilations). The main hypothesis is that early insertion of i-gel could improve CCF during out-of-hospital cardiac arrest, with a reasonable time to first effective ventilation.
Detailed description
Pre-scenario standardized workshop:
First, information about the study will be given and participants' questions are answered. Written consent will be obtained and the first part of the questionnaire individually completed. Participants will be told that the resuscitation scenario will be stopped after 10 minutes, independently of their actions and that no feedback will be given.
Then, the use of i-gel® device use will be taught by one of the investigators (LSt) in accordance with Peyton's approach because this approach has shown superiority, and based on a standard operating procedure created by study investigators following manufacturer's instructions:
- The instructor performs a complete insertion sequence in real-time without any comments;
- The instructor performs an insertion sequence with step-by-step explanations (description of key points);
- The learners guide the instructor step by step to perform the insertion;
- The learners do the complete insertion sequence then feedback could be given. They will perform this step a maximum of 3 times.
This workshop will last 20 minutes.
Self-managed training session:
After the workshop, each team will have 20 minutes to self-train the introduction of the device in the complete OHCA management sequence on a CPR manikin permitting airway management. They will be supported by a demonstration video, which they could use freely.
Resuscitation scenario:
When entering the study room, an overview of the characteristics of the simulation manikin and the use of the defibrillator will be given through a standardized video. The team will then be asked to perform a 10-minutes highly realistic adult CPR scenario on a high-fidelity WiFi manikin. The procedure will be standardized across all sites to ensure that each participant is exposed to exactly the same case, with similar challenges in decision-making and treatment provided on the same manikin. The uniform delivery of the scenario throughout the entire study will minimize confounders. The room will be exclusively devoted to the simulation to prevent unexpected interruptions or external stimuli.
The scenario will start with a clinical statement to recognize the life-threatening condition of the patient, given by one of the investigators as follows: " Here is Michael, a 50-years old who suddenly collapsed 10 minutes ago. He is now unconscious, pale and seems not breathing. The medical reinforcement is already underway and will be on site in about ten minutes. No first responder were dispatched to the scene and there is no bystander ". The team leader will be asked to reformulate this statement (closed-loop communication) to ensure comprehension. He will then open the following envelope of the stack. The opaque, sealed envelope will contain the approach they will have to apply: standard care or experimental approach. From this point on, there will be no more contact between the participants and the study team, except to stop the scenario.
If the participant checks the breathing, the patient will be apneic and pulse will be absent if checked. The first compression will be defined as T0. After placement of the pads, the defibrillator's display will show ventricular fibrillation (VF). All following rhythm analyses will show refractory VF, regardless of whether a shock is delivered. To increase simulation's fidelity, CPR waves will be displayed when compressions will be delivered. Participants will be able to obtain an intravenous access on first attempt. They should administer first 1 mg of epinephrine (at the earliest after the second shock), then a first-dose of amiodarone or lidocaine following local protocols (in accordance with the 2020 AHA cardiac arrest algorithm. The scenario will be stopped exactly 10 minutes after the first compression. There will be no feedback after the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, multicenter, randomized, controlled trial
| Arm | Type | Receives |
|---|---|---|
| I-gel® group | Experimental | Device: I-gel® supraglottic deviceContinuous chest compressions from the start of the CPR with early i-gel® device insertion and asynchronous ventilations |
| Standard group | Other | Device: Face mask ventilationBasic (standard) management by using a ratio of 30 compressions and 2 face mask ventilations |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- To be a registered paramedic or EMT
- To have previously completed the 20-minute workshop on how using the device by on of the study investigators
- To have previously completed the 20-minute self-training session following a video recorded by the study investigators
- Participation agreement
Key exclusion criteria (3 listed)
- Member of the study investigators
- To have not undergone the 20-minute workshop
- To have not watch the video
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 |
|---|---|---|
| I-gel® supraglottic deviceUse of an i-gel® supraglottic device to deliver ventilations | Device | I-gel® group |
| Face mask ventilationUse of a face mask to deliver ventilations | Device | Standard group |
Primary outcome
Chest compressions fraction (CCF) over the first 2 minutes of CPR
Time frame: At the end of Cycle 1 (each cycle is 2 minutes)
Proportion of time where compressions are performed during the first two minutes of the scenario
17 secondary outcomes
CCF of second cycle
Time frame: At the end of Cycle 2 (each cycle is 2 minutes)
CCF of third cycle
Time frame: At the end of Cycle 3 (each cycle is 2 minutes)
CCF of fourth cycle
Time frame: At the end of Cycle 4 (each cycle is 2 minutes)
CCF of fifth cycle
Time frame: At the end of Cycle 5 (each cycle is 2 minutes)
Overall CCF
Time frame: 10 minutes of scenario
Chest compressions depth
Time frame: 10 minutes of scenario
Proportions of compressions above, below and in the depth target
Time frame: 10 minutes of scenario
Chest compressions frequency
Time frame: 10 minutes of scenario
Proportions of compressions above, below and in the frequency target
Time frame: 10 minutes of scenario
Time to first shock
Time frame: 10 minutes of scenario
Time to first effective ventilation
Time frame: 10 minutes of scenario
Ventilations volume
Time frame: 10 minutes of scenario
Proportions of ventilations above, below and in the volume target
Time frame: 10 minutes of scenario
User satisfaction assessed by a 5-point Likert scale ranging from "Not satisfied" to "Very satisfied"
Time frame: 10 minutes of scenario
Self-assessed cognitive load using a 9-point scale ranging from "Very, very low mentale effort" to "Very, very high mental effort"
Time frame: 10 minutes of scenario
Chest compression relaxation
Time frame: 10 minutes of scenario
Number of delivered ventilations
Time frame: 10 minutes of scenario
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 12 Nov 2024.
- Background: PubMed 33804664Stuby L, Jampen L, Sierro J, Paus E, Spichiger T, Suppan L, Thurre D. Effect on Chest Compression Fraction of Continuous Manual Compressions with Asynchronous Ventilations Using an i-gel(R) versus 30:2 Approach during Simulated Out-of-Hospital Cardiac Arrest: Protocol for a Manikin Multicenter Randomized Controlled Trial. Healthcare (Basel). 2021 Mar 20;9(3):354. doi: 10.3390/healthcare9030354.
- Background: PubMed 35455895Stuby L, Suppan L, Jampen L, Thurre D. Impact of the Over-the-Head Position with a Supraglottic Airway Device on Chest Compression Depth and Rate: A Post Hoc Analysis of a Randomized Controlled Trial. Healthcare (Basel). 2022 Apr 13;10(4):718. doi: 10.3390/healthcare10040718.
- Results publication: PubMed 35011958Stuby L, Jampen L, Sierro J, Bergeron M, Paus E, Spichiger T, Suppan L, Thurre D. Effect of Early Supraglottic Airway Device Insertion on Chest Compression Fraction during Simulated Out-of-Hospital Cardiac Arrest: Randomised Controlled Trial. J Clin Med. 2021 Dec 31;11(1):217. doi: 10.3390/jcm11010217.
- Whole project websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All collected IPD will be deposited on Mendeley Data
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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.
Loric Stuby principal investigator
Genève TEAM Ambulances
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-gel® supraglottic device and Face mask ventilation in people with Cardiac Arrest and Cardiopulmonary Arrest, run by Geneve TEAM Ambulances 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 4 inclusion and 3 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 12 Nov 2024. 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?
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?
Chest compressions fraction (CCF) over the first 2 minutes of CPR (time frame: At the end of Cycle 1 (each cycle is 2 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 NCT04736446, 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 12 Nov 2024.