CClinicalTrials.gg
CompletedNCT05709613Updated Sep 18, 2023

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

An interventional study of Use of a chest compressions' feedback device in Cardiac Arrest, Cardiopulmonary Arrest and Resuscitation, sponsored by Geneve TEAM Ambulances. Completed at 4 sites in Switzerland. Per ClinicalTrials.gov, last updated 2023-09-18.

Sponsored by Geneve TEAM Ambulances · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Cardiac Arrest
  • Cardiopulmonary Arrest
  • Resuscitation
  • Emergency Medicine
03

In context

Heart Arrest

966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.

This study's enrollment of 34 is below the median of 100 across 557 interventional studies indexed under Heart Arrest.

Browse Heart Arrest studies →

Lead sponsor

Geneve TEAM Ambulances is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Exclusion Criteria:

  • Members of the study team
  • EMTs will be randomly excluded if there are more EMTs than paramedics.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • 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

Interventions

  • DeviceUse of a chest compressions' feedback device

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

06

What researchers measure

Primary outcomes

  1. Compressions within the depth target

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

    Time frame: Through study completion, i.e.10 minutes of scenario.

Secondary outcomes

  1. Overall chest compression fraction

    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.

  2. Depth of chest compressions

    The depth of chest compressions measured in centimeters

    Time frame: Through study completion, i.e.10 minutes of scenario.

  3. Compressions within the rate target

    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.

  4. Rate of chest compressions

    The rate of chest compressions measured in compressions per minute

    Time frame: Through study completion, i.e.10 minutes of scenario.

  5. Compressions with correct chest recoil

    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.

  6. 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)

    Time frame: Through study completion, i.e.10 minutes of scenario.

07

Study locations

4 sites
  • ACE Genève Ambulances
    Chêne-Bougeries, Geneva 1224, Switzerland
  • Ambulances de la Ville de Sion
    Sion, Valais 1950, Switzerland
  • Genève TEAM Ambulances
    Geneva, 1201, Switzerland
  • SK Ambulances
    Geneva, 1211, Switzerland
08

References and documents

Individual participant data

Plan to share: Yes — Data from the study will be available on Yareta as soon as the results are submitted for publication.

Supporting information: Study protocol

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05709613
Lead sponsor
Geneve TEAM Ambulances
Responsible party
Stuby Loric (Principal Investigator, Geneve TEAM Ambulances) — Principal investigator
First posted
Feb 2, 2023
Start date
Jan 30, 2023
Primary completion
Jun 13, 2023
Completion
Jun 13, 2023
Last update
Sep 18, 2023

Study contacts

Loric Stuby
principal investigator · Genève TEAM Ambulances

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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