NCT03140202

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2017

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

July 19, 2017

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

April 24, 2017

Last Update Submit

July 18, 2017

Conditions

Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Decrease time of 30% of correct compression score

    Day 0

  • Chest compression depth

    Day 0

  • Chest compression rate

    Day 0

  • Percentage of chest compression without leaning

    Day 0

  • Percentage of chest compression with correct depth

    Day 0

  • +2 more secondary outcomes

Other Outcomes (2)

  • Hemodynamic effect n1 of Cardiopulmonary Resuscitation

    Day 0

  • Hemodynamic effect n2 of Cardiopulmonary Resuscitation

    Day 0

Study Arms (2)

Guide then blind

EXPERIMENTAL

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 feedbackDevice: CPRmeter (feedback device) without feedback

Blind then guide

EXPERIMENTAL

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 feedbackDevice: CPRmeter (feedback device) without feedback

Interventions

CPRmeter (feedback device) with feedbackDEVICE

Participants have a real time feedback and record.

Blind then guideGuide then blind
CPRmeter (feedback device) without feedbackDEVICE

Participants have a real time record without feedback.

Blind then guideGuide then blind

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

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, Normandy, 14033, France

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Clement BULEON, MD

    Medical Simulation Center Normandie Simulation en Sante

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clement BULEON, MD

CONTACT

+(33)231064736buleon-c@chu-caen.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2017

First Posted

May 4, 2017

Study Start

April 18, 2017

Primary Completion

September 15, 2017

Study Completion

October 1, 2017

Last Updated

July 19, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)