Use of a Feedback Device to Limit Too Shallow Compressions Associated With the Use of an I-gel® Device

• ClinicalTrials.gov Identifier: NCT05709613
• Recruitment Status: Enrolling by invitation
• First Posted: February 2, 2023
• Last Update Posted: February 2, 2023
• Sponsor: Geneve TEAM Ambulances
• Information provided by (Responsible Party): Stuby Loric, Geneve TEAM Ambulances

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
Cardiac Arrest; Cardiopulmonary Arrest; Resuscitation; Emergency Medicine	Device: Use of a chest compressions' feedback device	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: Data extraction will be fully automated and the statistician will not know the identity of the participants or the sequence they were allocated to.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: January 30, 2023
• Estimated Primary Completion Date: July 15, 2023
• Estimated Study Completion Date: July 15, 2023

Arms and Interventions

Arm	Intervention/treatment
No Intervention: No feedback device; This group will have no access to the feedback device
Experimental: Feedback device; This group will have access to the feedback device	Device: Use of a chest compressions' feedback device; The participants will have access to a chest compressions' feedback device

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Overall chest compression fraction [ Time Frame: Through study completion, i.e.10 minutes of scenario. ]
   The chest compression fraction is the time during which compressions are provided divided by the total time of the resuscitation
2. Depth of chest compressions [ Time Frame: Through study completion, i.e.10 minutes of scenario. ]
   The depth of chest compressions measured in centimeters
3. Compressions within the rate target [ Time Frame: Through study completion, i.e.10 minutes of scenario. ]
   Proportions of compressions within the rate target of 100 to 120 compressions per minute
4. Rate of chest compressions [ Time Frame: Through study completion, i.e.10 minutes of scenario. ]
   The rate of chest compressions measured in compressions per minute
5. Compressions with correct chest recoil [ Time Frame: Through study completion, i.e.10 minutes of scenario. ]
   The proportions of compressions with complete chest recoil (less than 5 millimeters of deviation from the reference value)
6. Time to first effective ventilation [ Time Frame: Through study completion, i.e.10 minutes of scenario. ]
   The time measured in seconds from beginning of the resuscitation to first effective ventilation (defined as at least 300 millilitres)

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Registered EMTs and paramedics actively working in any of the participating study trial centers will be eligible for inclusion.

Exclusion Criteria:

• Members of the study team
• EMTs will be randomly excluded if there are more EMTs than paramedics.

Contacts and Locations

Locations

Switzerland

ACE Genève Ambulances

Chêne-Bougeries, Geneva, Switzerland, 1224

Ambulances de la Ville de Sion

Sion, Valais, Switzerland, 1950

Genève TEAM Ambulances

Geneva, Switzerland, 1201

SK Ambulances

Geneva, Switzerland, 1211

Sponsors and Collaborators

Geneve TEAM Ambulances

Investigators

• Principal Investigator: Loric Stuby; Genève TEAM Ambulances

More Information

Additional Information:

Whole project website 

• Responsible Party: Stuby Loric, Principal Investigator, Geneve TEAM Ambulances
• ClinicalTrials.gov Identifier: NCT05709613
• Other Study ID Numbers: CPR-7
• First Posted: February 2, 2023
• Last Update Posted: February 2, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Data from the study will be available on Yareta as soon as the results are submitted for publication.
• Supporting Materials: Study Protocol
• Time Frame: Once the final results will be submitted for publication
• Access Criteria: Free access

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Heart Arrest; Emergencies; Disease Attributes; Pathologic Processes; Heart Diseases; Cardiovascular Diseases