NCT05709613

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

January 30, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2023

Completed
Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

4 months

First QC Date

January 8, 2023

Last Update Submit

September 15, 2023

Conditions

Cardiac ArrestCardiopulmonary ArrestResuscitationEmergency Medicine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Overall chest compression fraction

    Through study completion, i.e.10 minutes of scenario.

  • Depth of chest compressions

    Through study completion, i.e.10 minutes of scenario.

  • Compressions within the rate target

    Through study completion, i.e.10 minutes of scenario.

  • Rate of chest compressions

    Through study completion, i.e.10 minutes of scenario.

  • Compressions with correct chest recoil

    Through study completion, i.e.10 minutes of scenario.

  • +1 more secondary outcomes

Study Arms (2)

No feedback device

NO INTERVENTION

This group will have no access to the feedback device

Feedback device

EXPERIMENTAL

This group will have access to the feedback device

Device: Use of a chest compressions' feedback device

Interventions

Use of a chest compressions' feedback deviceDEVICE

The participants will have access to a chest compressions' feedback device

Feedback device

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

ACE Genève Ambulances

Chêne-Bougeries, Canton of Geneva, 1224, Switzerland

Location

Ambulances de la Ville de Sion

Sion, Valais, 1950, Switzerland

Location

Genève TEAM Ambulances

Geneva, 1201, Switzerland

Location

SK Ambulances

Geneva, 1211, Switzerland

Location

Related Links

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Loric Stuby

    Genève TEAM Ambulances

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Data extraction will be fully automated and the statistician will not know the identity of the participants or the sequence they were allocated to.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 8, 2023

First Posted

February 2, 2023

Study Start

January 30, 2023

Primary Completion

June 13, 2023

Study Completion

June 13, 2023

Last Updated

September 18, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

Data from the study will be available on Yareta as soon as the results are submitted for publication.

Shared Documents
STUDY PROTOCOL
Time Frame
Once the final results will be submitted for publication
Access Criteria
Free access

Locations

CH(4)