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

Primary Purpose

Cardiac Arrest, Cardiopulmonary Arrest, Resuscitation

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Use of a chest compressions' feedback device
Sponsored by
Geneve TEAM Ambulances
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • ACE Genève Ambulances
  • Ambulances de la Ville de Sion
  • Genève TEAM Ambulances
  • SK Ambulances

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No feedback device

Feedback device

Arm Description

This group will have no access to the feedback device

This group will have access to the feedback device

Outcomes

Primary Outcome Measures

Compressions within the depth target
Proportions of compressions within the depth target of 5 to 6 centimeters

Secondary Outcome Measures

Overall chest compression fraction
The chest compression fraction is the time during which compressions are provided divided by the total time of the resuscitation
Depth of chest compressions
The depth of chest compressions measured in centimeters
Compressions within the rate target
Proportions of compressions within the rate target of 100 to 120 compressions per minute
Rate of chest compressions
The rate of chest compressions measured in compressions per minute
Compressions with correct chest recoil
The proportions of compressions with complete chest recoil (less than 5 millimeters of deviation from the reference value)
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)

Full Information

First Posted
January 8, 2023
Last Updated
September 15, 2023
Sponsor
Geneve TEAM Ambulances
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1. Study Identification

Unique Protocol Identification Number
NCT05709613
Brief Title
Use of a Feedback Device to Limit Too Shallow Compressions Associated With the Use of an I-gel® Device
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
June 13, 2023 (Actual)
Study Completion Date
June 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Geneve TEAM Ambulances

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Cardiopulmonary Arrest, Resuscitation, Emergency Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No feedback device
Arm Type
No Intervention
Arm Description
This group will have no access to the feedback device
Arm Title
Feedback device
Arm Type
Experimental
Arm Description
This group will have access to the feedback device
Intervention Type
Device
Intervention Name(s)
Use of a chest compressions' feedback device
Intervention Description
The participants will have access to a chest compressions' feedback device
Primary Outcome Measure Information:
Title
Compressions within the depth target
Description
Proportions of compressions within the depth target of 5 to 6 centimeters
Time Frame
Through study completion, i.e.10 minutes of scenario.
Secondary Outcome Measure Information:
Title
Overall chest compression fraction
Description
The chest compression fraction is the time during which compressions are provided divided by the total time of the resuscitation
Time Frame
Through study completion, i.e.10 minutes of scenario.
Title
Depth of chest compressions
Description
The depth of chest compressions measured in centimeters
Time Frame
Through study completion, i.e.10 minutes of scenario.
Title
Compressions within the rate target
Description
Proportions of compressions within the rate target of 100 to 120 compressions per minute
Time Frame
Through study completion, i.e.10 minutes of scenario.
Title
Rate of chest compressions
Description
The rate of chest compressions measured in compressions per minute
Time Frame
Through study completion, i.e.10 minutes of scenario.
Title
Compressions with correct chest recoil
Description
The proportions of compressions with complete chest recoil (less than 5 millimeters of deviation from the reference value)
Time Frame
Through study completion, i.e.10 minutes of scenario.
Title
Time to first effective ventilation
Description
The time measured in seconds from beginning of the resuscitation to first effective ventilation (defined as at least 300 millilitres)
Time Frame
Through study completion, i.e.10 minutes of scenario.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loric Stuby
Organizational Affiliation
Genève TEAM Ambulances
Official's Role
Principal Investigator
Facility Information:
Facility Name
ACE Genève Ambulances
City
Chêne-Bougeries
State/Province
Geneva
ZIP/Postal Code
1224
Country
Switzerland
Facility Name
Ambulances de la Ville de Sion
City
Sion
State/Province
Valais
ZIP/Postal Code
1950
Country
Switzerland
Facility Name
Genève TEAM Ambulances
City
Geneva
ZIP/Postal Code
1201
Country
Switzerland
Facility Name
SK Ambulances
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data from the study will be available on Yareta as soon as the results are submitted for publication.
IPD Sharing Time Frame
Once the final results will be submitted for publication
IPD Sharing Access Criteria
Free access
Links:
URL
https://swiss-cpr-studies.ch/
Description
Whole project website

Learn more about this trial

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

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