Compression Is Life In Cardiac Arrest - Quality Study (CILICA-QS) (CILICA-QS)

July 18, 2017 updated by: University Hospital, Caen

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Normandy
      • Caen, Normandy, France, 14033
        • Recruiting
        • University Hospital of Caen
        • Sub-Investigator:
          • Christophe PERSYN, MD
        • Sub-Investigator:
          • Tiphaine BRY
        • Sub-Investigator:
          • Anne-Laure LEPORI, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Operational staff of University hospital of Caen pre-hospital unit
  • Ability in CardioPulmonary Resuscitation

Exclusion Criteria:

  • medical contraindication
  • refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Guide then blind
This group use the CPRmeter visual feedback during cardiopulmonary resuscitation (screen visible) first, then have no access to the CPRmeter visual feedback during cardiopulmonary resuscitation (screen mask).
Device: CPRmeter (feedback device) with feedback
Participants have a real time feedback and record.
Device: CPRmeter (feedback device) without feedback
Participants have a real time record without feedback.
EXPERIMENTAL: Blind then guide
This group have no access to the CPRmeter visual feedback during cardiopulmonary resuscitation (screen mask) first then use the CPRmeter visual feedback during cardiopulmonary resuscitation (screen visible).
Device: CPRmeter (feedback device) with feedback
Participants have a real time feedback and record.
Device: CPRmeter (feedback device) without feedback
Participants have a real time record without feedback.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correct compression score
Time Frame: Day 0
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease time of 30% of correct compression score
Time Frame: Day 0
Time at witch correct compression score decrease of 30% of the reference correct compression score (first 20 secondes)
Day 0
Chest compression depth
Time Frame: Day 0
Chest compression depth reached (in mm)
Day 0
Chest compression rate
Time Frame: Day 0
Chest compression rate per min
Day 0
Percentage of chest compression without leaning
Time Frame: Day 0
Percentage of chest compression without leaning defined with a residual weight egal or above 2500 g
Day 0
Percentage of chest compression with correct depth
Time Frame: Day 0
Percentage of chest compression with depth between 50 mm and 60 mm
Day 0
Percentage of correct chest compression rate
Time Frame: Day 0
Percentage chest compression rate between 100/min and 120/min
Day 0
Participants' fatigue (Borg's scale)
Time Frame: Day 0
Participant auto-evaluation of fatigue with a predefined scale from 6 to 20 (no unit).
Day 0

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemodynamic effect n1 of Cardiopulmonary Resuscitation
Time Frame: Day 0
Impact of Cardiopulmonary Resuscitation effort on participant blood pressure (mmHg)
Day 0
Hemodynamic effect n2 of Cardiopulmonary Resuscitation
Time Frame: Day 0
Impact of Cardiopulmonary Resuscitation effort on participant heart frequency (/min)
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Investigators

  • Principal Investigator: Clement BULEON, MD, Medical Simulation Center Normandie Simulation en Sante

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 18, 2017

Primary Completion (ANTICIPATED)

September 15, 2017

Study Completion (ANTICIPATED)

October 1, 2017

Study Registration Dates

First Submitted

April 24, 2017

First Submitted That Met QC Criteria

May 2, 2017

First Posted (ACTUAL)

May 4, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 19, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A16-D51-VOL.30

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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