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NCT02322359 Clinical Trial

Compression Is Life In Cardiac Arrest - Fatigue Study

Cardiac Arrest Clinical Trial

— CILICA-FS  

Official title:
Impact of a Feedback Device, CPRmeter®, on Chest Compression Quality During Extend Cardio-pulmonary Resuscitation. A Manikin Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02322359
Other study ID # A14-D20-VOL.21
Secondary ID
Status Completed
Phase N/A
First received November 27, 2014
Last updated December 19, 2014
Start date August 2014
Est. completion date September 2014

Study information
Verified date December 2014
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- medical contraindication

- refusal

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
France University Hospital of Caen Caen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correct compression score Correct compression score is defined by reached target of rate, depth and leaning at the same time 24h No
Secondary Decrease time of 30% of correct compression score 24h No
Secondary chest compression deep 24h No
Secondary chest compression rate 24h No
Secondary percentage of chest compression without leaning 24h No
Secondary percentage of chest compression with correct deep 24h No
Secondary percentage of correct chest compression rate 24h No
Secondary participants' fatigue (Borg's scale) 24h No
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