NCT02322359

Brief Summary

Context: Chest compressions represent an important physical effort leading to fatigue and cardiopulmonary resuscitation quality degradation. Despite a known harmful effect of chest compressions interruptions, current guidelines still recommend provider switch every 2 minutes. Feedback impact on chest compressions quality during an extended cardiopulmonary resuscitation remains to be assessed. Study design: simulated prospective monocentric randomized crossover trial. Participants and methods: Sixty professionals rescuers of the pre-hospital care unit of University Hospital of Caen (doctors, nurses and ambulance drivers) are enrolled to performed 10 minutes of continuous chest compression on manikin (ResusciAnne®, Laerdal), twice, with and without a feedback device (CPRmeter®). Correct compression score (the main criterion) is defined by reached target of rate, depth and leaning at the same time (recorded continuously). Hypothesis: Feedback device delay fatigue effect arises during cardiopulmonary resuscitation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2014

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 23, 2014

Completed
Last Updated

December 23, 2014

Status Verified

December 1, 2014

Enrollment Period

1 month

First QC Date

November 27, 2014

Last Update Submit

December 19, 2014

Conditions

Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

  • Correct compression score

    Correct compression score is defined by reached target of rate, depth and leaning at the same time

    24h

Secondary Outcomes (7)

  • Decrease time of 30% of correct compression score

    24h

  • chest compression deep

    24h

  • chest compression rate

    24h

  • percentage of chest compression without leaning

    24h

  • percentage of chest compression with correct deep

    24h

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Volunteers from University hospital of Caen pre-hospital unit

You may qualify if:

  • Operational staff of University hospital of Caen pre-hospital unit

You may not qualify if:

  • medical contraindication
  • refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Caen

Caen, 14033, France

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Clement BULEON, MD

    University Hospital of Caen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2014

First Posted

December 23, 2014

Study Start

August 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

December 23, 2014

Record last verified: 2014-12

Locations

FR(1)