Cardiac ArrestNCT05709613
Use of a Feedback Device to Limit Too Shallow Compressions Associated With the Use of an I-gel® Device
A study testing Use of a chest compressions' feedback device in people with Cardiac Arrest and Cardiopulmonary Arrest, run by Geneve TEAM Ambulances at 4 sites in Switzerland.
Trial summary
Airway management in out-of-hospital cardiac arrest is still debated. Several options exist: bag-valve-mask ventilation, supraglottic devices and endotracheal intubation. Intermediate and advanced airway management strategies could be useful devices to increase chest compression fraction. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest, Cardiopulmonary Arrest, Resuscitation
- What is being tested?
- Use of a chest compressions' feedback device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 4 sitesSwitzerland
- Study dates
- 30 Jan 2023to 13 Jun 2023
- 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
- Registered EMTs and paramedics actively working in any of the participating study trial centers will be eligible for inclusion.
Who cannot join
- Members of the study team
- EMTs will be randomly excluded if there are more EMTs than paramedics.
Trial locations and contacts
4 sites in 1 country.
Switzerland4 sites
ACE Genève Ambulances
Chêne-Bougeries, Canton of Geneva, 1224
Genève TEAM Ambulances
Geneva, 1201
SK Ambulances
Geneva, 1211
Ambulances de la Ville de Sion
Sion, Valais, 1950
About this study
Official title: Use of a Feedback Device to Limit Too Shallow Compressions Associated With the Use of an I-gel® Device During Simulated Out-of-Hospital Cardiac Arrest: Simulation-based Multicentre Randomised Controlled Trial
Airway management in out-of-hospital cardiac arrest is still debated. Several options exist: bag-valve-mask ventilation, supraglottic devices and endotracheal intubation. Intermediate and advanced airway management strategies could be useful devices to increase chest compression fraction. A previous study shows that early insertion of an i-gel device significantly increases chest compression fraction and enhances respiratory parameters. However, the compressions were found to be shallower in the experimental group using the i-gel device. Although, the shallower compressions found in the supraglottic airway device group did not appear to be linked to their provision in an over-the-head position, it is reasonable to assume that the addition of a feedback device to the use of an i-gel® device could fix this issue. The feedback devices seem to be able to provide a benefit, and allow deeper compressions / more often in the depth target. There is a mismatch between perceived and actual cardiopulmonary resuscitation performance supporting the need for such a feedback device's study.
- Being tested
- Use of a chest compressions' feedback device
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of a chest compressions' feedback deviceDevice
The participants will have access to a chest compressions' feedback device
| Study group | Role | What they receive |
|---|---|---|
| No feedback device | No intervention | This group will have no access to the feedback device |
| Feedback device | Experimental | This group will have access to the feedback device Receives: Device: Use of a chest compressions' feedback device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compressions within the depth target
Proportions of compressions within the depth target of 5 to 6 centimeters
Measured: Through study completion, i.e.10 minutes of scenario.
Secondary outcomes (6)
Overall chest compression fraction
The chest compression fraction is the time during which compressions are provided divided by the total time of the resuscitation
Measured: Through study completion, i.e.10 minutes of scenario.
Depth of chest compressions
The depth of chest compressions measured in centimeters
Measured: Through study completion, i.e.10 minutes of scenario.
Compressions within the rate target
Proportions of compressions within the rate target of 100 to 120 compressions per minute
Measured: Through study completion, i.e.10 minutes of scenario.
Rate of chest compressions
The rate of chest compressions measured in compressions per minute
Measured: Through study completion, i.e.10 minutes of scenario.
Compressions with correct chest recoil
The proportions of compressions with complete chest recoil (less than 5 millimeters of deviation from the reference value)
Measured: Through study completion, i.e.10 minutes of scenario.
Time to first effective ventilation
The time measured in seconds from beginning of the resuscitation to first effective ventilation (defined as at least 300 millilitres)
Measured: Through study completion, i.e.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 posted2 Feb 2023
- Study start30 Jan 2023
- Primary completion13 Jun 2023
- Study completion13 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geneve TEAM Ambulances
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuby Loric, Geneve TEAM Ambulances
- Investigators
- Loric Stuby, Principal investigator, Genève TEAM Ambulances
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709613
- Sponsor's protocol ID
- CPR-7
- Status last verified
- Sep 2023
- First submitted
- 8 Jan 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from the study will be available on Yareta as soon as the results are submitted for publication.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Feedback Device to Limit Too Shallow Compressions Associated With the Use of an I-gel® Device During Simulated Out-of-Hospital Cardiac Arrest: Simulation-based Multicentre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05709613
- Acronym / sponsor ID
- CPR-7
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Geneve TEAM AmbulancesUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 13 Jun 2023 (actual)
- Study completion
- 13 Jun 2023 (actual)
- First posted
- 2 Feb 2023 (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.
Airway management in out-of-hospital cardiac arrest is still debated. Several options exist: bag-valve-mask ventilation, supraglottic devices and endotracheal intubation. Intermediate and advanced airway management strategies could be useful devices to increase chest compression fraction. A previous study shows that early insertion of an i-gel device significantly increases chest compression fraction and enhances respiratory parameters. However, the compressions were found to be shallower in the experimental group using the i-gel device. Although, the shallower compressions found in the supraglottic airway device group did not appear to be linked to their provision in an over-the-head position, it is reasonable to assume that the addition of a feedback device to the use of an i-gel® device could fix this issue. The feedback devices seem to be able to provide a benefit, and allow deeper compressions / more often in the depth target. There is a mismatch between perceived and actual cardiopulmonary resuscitation performance supporting the need for such a feedback device's study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No feedback device | No intervention | –This group will have no access to the feedback device |
| Feedback device | Experimental | Device: Use of a chest compressions' feedback deviceThis group will have access to the feedback device |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Registered EMTs and paramedics actively working in any of the participating study trial centers will be eligible for inclusion.
Key exclusion criteria (2 listed)
- Members of the study team
- EMTs will be randomly excluded if there are more EMTs than paramedics.
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 |
|---|---|---|
| Use of a chest compressions' feedback deviceThe participants will have access to a chest compressions' feedback device | Device | Feedback device |
Primary outcome
Compressions within the depth target
Time frame: Through study completion, i.e.10 minutes of scenario.
Proportions of compressions within the depth target of 5 to 6 centimeters
6 secondary outcomes
Overall chest compression fraction
Time frame: Through study completion, i.e.10 minutes of scenario.
Depth of chest compressions
Time frame: Through study completion, i.e.10 minutes of scenario.
Compressions within the rate target
Time frame: Through study completion, i.e.10 minutes of scenario.
Rate of chest compressions
Time frame: Through study completion, i.e.10 minutes of scenario.
Compressions with correct chest recoil
Time frame: Through study completion, i.e.10 minutes of scenario.
Time to first effective ventilation
Time frame: Through study completion, i.e.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 18 Sep 2023.
- Whole project websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data from the study will be available on Yareta as soon as the results are submitted for publication.
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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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of a chest compressions' feedback device in people with Cardiac Arrest and Cardiopulmonary Arrest, run by Geneve TEAM Ambulances at 4 sites 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 1 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 Sep 2023. 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 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?
Compressions within the depth target (time frame: Through study completion, i.e.10 minutes of scenario.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2023.