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

Primary Purpose

Cardiac Arrest

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CPRmeter (feedback device) with feedback
CPRmeter (feedback device) without feedback
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cardiac Arrest

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • medical contraindication
  • refusal

Sites / Locations

  • University Hospital of CaenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Guide then blind

Blind then guide

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
Chest compression depth
Chest compression depth reached (in mm)
Chest compression rate
Chest compression rate per min
Percentage of chest compression without leaning
Percentage of chest compression without leaning defined with a residual weight egal or above 2500 g
Percentage of chest compression with correct depth
Percentage of chest compression with depth between 50 mm and 60 mm
Percentage of correct chest compression rate
Percentage chest compression rate between 100/min and 120/min
Participants' fatigue (Borg's scale)
Participant auto-evaluation of fatigue with a predefined scale from 6 to 20 (no unit).

Full Information

First Posted
April 24, 2017
Last Updated
July 18, 2017
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT03140202
Brief Title
Compression Is Life In Cardiac Arrest - Quality Study (CILICA-QS)
Acronym
CILICA-QS
Official Title
Impact of a Feedback Device, CPRmeter®, on Chest Compression Quality Preservation During Cardio-pulmonary Resuscitation: A Manikin Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 18, 2017 (Actual)
Primary Completion Date
September 15, 2017 (Anticipated)
Study Completion Date
October 1, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
In Guide group, participants have a real time feedback (and record) on chest compression quality performed by means of the visuals informations profided by the feedback device. In Blind group, participants have a real time record of chest compression quality performed by means of the feedback device without feedback information of the performance.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Guide then blind
Arm Type
Experimental
Arm Description
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).
Arm Title
Blind then guide
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
CPRmeter (feedback device) with feedback
Intervention Description
Participants have a real time feedback and record.
Intervention Type
Device
Intervention Name(s)
CPRmeter (feedback device) without feedback
Intervention Description
Participants have a real time record without feedback.
Primary Outcome Measure Information:
Title
Correct compression score
Description
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
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Decrease time of 30% of correct compression score
Description
Time at witch correct compression score decrease of 30% of the reference correct compression score (first 20 secondes)
Time Frame
Day 0
Title
Chest compression depth
Description
Chest compression depth reached (in mm)
Time Frame
Day 0
Title
Chest compression rate
Description
Chest compression rate per min
Time Frame
Day 0
Title
Percentage of chest compression without leaning
Description
Percentage of chest compression without leaning defined with a residual weight egal or above 2500 g
Time Frame
Day 0
Title
Percentage of chest compression with correct depth
Description
Percentage of chest compression with depth between 50 mm and 60 mm
Time Frame
Day 0
Title
Percentage of correct chest compression rate
Description
Percentage chest compression rate between 100/min and 120/min
Time Frame
Day 0
Title
Participants' fatigue (Borg's scale)
Description
Participant auto-evaluation of fatigue with a predefined scale from 6 to 20 (no unit).
Time Frame
Day 0
Other Pre-specified Outcome Measures:
Title
Hemodynamic effect n1 of Cardiopulmonary Resuscitation
Description
Impact of Cardiopulmonary Resuscitation effort on participant blood pressure (mmHg)
Time Frame
Day 0
Title
Hemodynamic effect n2 of Cardiopulmonary Resuscitation
Description
Impact of Cardiopulmonary Resuscitation effort on participant heart frequency (/min)
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Operational staff of University hospital of Caen pre-hospital unit Ability in CardioPulmonary Resuscitation Exclusion Criteria: medical contraindication refusal
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clement BULEON, MD
Phone
+(33)231064736
Email
buleon-c@chu-caen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clement BULEON, MD
Organizational Affiliation
Medical Simulation Center Normandie Simulation en Sante
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Caen
City
Caen
State/Province
Normandy
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clement BULEON, MD
Phone
+(33)231064736
Email
buleon-c@chu-caen.fr
First Name & Middle Initial & Last Name & Degree
Christophe PERSYN, MD
First Name & Middle Initial & Last Name & Degree
Tiphaine BRY
First Name & Middle Initial & Last Name & Degree
Laurent HALBOUT, MD
First Name & Middle Initial & Last Name & Degree
Xavier ARROT, MD
First Name & Middle Initial & Last Name & Degree
Anne-Laure LEPORI, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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