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

Sponsor
Geneve TEAM Ambulances (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05709613
Collaborator
(none)
32
4
2
5.5
8
1.5

Study Details

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
  • Device: Use of a chest compressions' feedback device
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 30, 2023
Anticipated Primary Completion Date :
Jul 15, 2023
Anticipated Study Completion Date :
Jul 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 [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 [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 [Through study completion, i.e.10 minutes of scenario.]

    The depth of chest compressions measured in centimeters

  3. Compressions within the rate target [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 [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 [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 [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

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Site City State Country Postal Code
1 ACE Genève Ambulances Chêne-Bougeries Geneva Switzerland 1224
2 Ambulances de la Ville de Sion Sion Valais Switzerland 1950
3 Genève TEAM Ambulances Geneva Switzerland 1201
4 SK Ambulances Geneva Switzerland 1211

Sponsors and Collaborators

  • Geneve TEAM Ambulances

Investigators

  • Principal Investigator: Loric Stuby, Genève TEAM Ambulances

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Stuby Loric, Principal Investigator, Geneve TEAM Ambulances
ClinicalTrials.gov Identifier:
NCT05709613
Other Study ID Numbers:
  • CPR-7
First Posted:
Feb 2, 2023
Last Update Posted:
Feb 2, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 2, 2023