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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03140202
Other study ID # A16-D51-VOL.30
Secondary ID
Status Recruiting
Phase N/A
First received April 24, 2017
Last updated July 18, 2017
Start date April 18, 2017
Est. completion date October 1, 2017

Study information

Verified date April 2017
Source University Hospital, Caen
Contact Clement BULEON, MD
Phone +(33)231064736
Email buleon-c@chu-caen.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Context: Chest compressions quality is known to be essential in cardiopulmonary resuscitation. Despite a known harmful effect of chest compressions interruptions, current guidelines still recommend provider switch every 2 minutes. Feedback impact on chest compressions quality preservation during cardiopulmonary resuscitation remains to be assessed.

Study design: simulated prospective monocentric randomized crossover trial.

Participants and methods: Sixty five professionals rescuers of the pre-hospital care unit of University Hospital of Caen (doctors, nurses and ambulance drivers) are enrolled to performed 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 preserve chest compression quality above the 2 minutes recommended switch over during cardiopulmonary resuscitation.


Recruitment information / eligibility

Status Recruiting
Enrollment 65
Est. completion date October 1, 2017
Est. primary completion date September 15, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

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

- Ability in CardioPulmonary Resuscitation

Exclusion Criteria:

- medical contraindication

- refusal

Study Design


Related Conditions & MeSH terms


Intervention

Device:
CPRmeter (feedback device) with feedback
Participants have a real time feedback and record.
CPRmeter (feedback device) without feedback
Participants have a real time record without feedback.

Locations

Country Name City State
France University Hospital of Caen Caen Normandy

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Hemodynamic effect n1 of Cardiopulmonary Resuscitation Impact of Cardiopulmonary Resuscitation effort on participant blood pressure (mmHg) Day 0
Other Hemodynamic effect n2 of Cardiopulmonary Resuscitation Impact of Cardiopulmonary Resuscitation effort on participant heart frequency (/min) Day 0
Primary Correct compression score Correct compression score is defined by reached target of rate (between 100/min and 120/min), depth (between 50 mm and 60 mm) and leaning (less than 2500g) at the same time Day 0
Secondary Decrease time of 30% of correct compression score Time at witch correct compression score decrease of 30% of the reference correct compression score (first 20 secondes) Day 0
Secondary Chest compression depth Chest compression depth reached (in mm) Day 0
Secondary Chest compression rate Chest compression rate per min Day 0
Secondary Percentage of chest compression without leaning Percentage of chest compression without leaning defined with a residual weight egal or above 2500 g Day 0
Secondary Percentage of chest compression with correct depth Percentage of chest compression with depth between 50 mm and 60 mm Day 0
Secondary Percentage of correct chest compression rate Percentage chest compression rate between 100/min and 120/min Day 0
Secondary Participants' fatigue (Borg's scale) Participant auto-evaluation of fatigue with a predefined scale from 6 to 20 (no unit). Day 0
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