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

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.

Study Overview

• Status: Completed
• Conditions: Emergency Medicine; Cardiac Arrest; Resuscitation; Cardiopulmonary Arrest
• Intervention / Treatment: Device: Use of a chest compressions' feedback device

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1201
    • Genève TEAM Ambulances
  • Geneva, Switzerland, 1211
    • SK Ambulances
  • Geneva
    • Chêne-Bougeries, Geneva, Switzerland, 1224
      • ACE Genève Ambulances
  • Valais
    • Sion, Valais, Switzerland, 1950
      • Ambulances de la Ville de Sion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compressions within the depth target	Proportions of compressions within the depth target of 5 to 6 centimeters	Through study completion, i.e.10 minutes of scenario.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall chest compression fraction	The chest compression fraction is the time during which compressions are provided divided by the total time of the resuscitation	Through study completion, i.e.10 minutes of scenario.
Depth of chest compressions	The depth of chest compressions measured in centimeters	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	Through study completion, i.e.10 minutes of scenario.
Rate of chest compressions	The rate of chest compressions measured in compressions per minute	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)	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)	Through study completion, i.e.10 minutes of scenario.

Collaborators and Investigators

• Sponsor: Geneve TEAM Ambulances
• Investigators: Principal Investigator: Loric Stuby, Genève TEAM Ambulances

Publications and helpful links

Helpful Links

• Whole project website

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Actual): June 13, 2023
• Study Completion (Actual): June 13, 2023

Study Registration Dates

• First Submitted: January 8, 2023
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (Actual): February 2, 2023

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Emergencies; Heart Arrest
• Other Study ID Numbers: CPR-7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No