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

Cardiac Arrest Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05709613
• Other study ID #: CPR-7
• Status: Completed
• Phase: N/A
• Start date: January 30, 2023
• Est. completion date: June 13, 2023

Study information

• Verified date: September 2023
• Source: Geneve TEAM Ambulances
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 13, 2023
• Est. primary completion date: June 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Arrest
• Cardiopulmonary Arrest
• Emergencies
• Emergency Medicine
• Heart Arrest
• Resuscitation

Intervention

Device:
• Use of a chest compressions' feedback device
The participants will have access to a chest compressions' feedback device

Locations

Country	Name	City	State
Switzerland	ACE Genève Ambulances	Chêne-Bougeries	Geneva
Switzerland	Genève TEAM Ambulances	Geneva
Switzerland	SK Ambulances	Geneva
Switzerland	Ambulances de la Ville de Sion	Sion	Valais

Sponsors (1)

Lead Sponsor	Collaborator
Geneve TEAM Ambulances

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Depth of chest compressions	The depth of chest compressions measured in centimeters	Through study completion, i.e.10 minutes of scenario.
Secondary	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.
Secondary	Rate of chest compressions	The rate of chest compressions measured in compressions per minute	Through study completion, i.e.10 minutes of scenario.
Secondary	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.
Secondary	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.

External Links

•   Whole project website