Cardiac ArrestCILICA-FSNCT02322359
Compression Is Life In Cardiac Arrest - Fatigue Study
An observational study of Cardiac Arrest, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2014to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteers from University hospital of Caen pre-hospital unit
Who may be able to join
- Operational staff of University hospital of Caen pre-hospital unit
Who cannot join
- medical contraindication
- refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Feedback Device, CPRmeter®, on Chest Compression Quality During Extend Cardio-pulmonary Resuscitation. A Manikin Study.
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.
- Conditions
- Cardiac Arrest
- Medical subject headings
- Heart Arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
Correct compression score
Correct compression score is defined by reached target of rate, depth and leaning at the same time
Measured: 24h
Secondary outcomes (7)
Decrease time of 30% of correct compression score
Measured: 24h
chest compression deep
Measured: 24h
chest compression rate
Measured: 24h
percentage of chest compression without leaning
Measured: 24h
percentage of chest compression with correct deep
Measured: 24h
percentage of correct chest compression rate
Measured: 24h
participants' fatigue (Borg's scale)
Measured: 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clement BULEON, MD, Principal investigator, University Hospital of Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322359
- Sponsor's protocol ID
- A14-D20-VOL.21
- Acronym
- CILICA-FS
- Status last verified
- Dec 2014
- First submitted
- 27 Nov 2014
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Feedback Device, CPRmeter®, on Chest Compression Quality During Extend Cardio-pulmonary Resuscitation. A Manikin Study.
- ClinicalTrials.gov ID
- NCT02322359
- Acronym / sponsor ID
- CILICA-FS / A14-D20-VOL.21
- Conditions
- Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers from University hospital of Caen pre-hospital unit
Key inclusion criteria (1 listed)
- Operational staff of University hospital of Caen pre-hospital unit
Key exclusion criteria (2 listed)
- medical contraindication
- refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correct compression score
Time frame: 24h
Correct compression score is defined by reached target of rate, depth and leaning at the same time
7 secondary outcomes
Decrease time of 30% of correct compression score
Time frame: 24h
chest compression deep
Time frame: 24h
chest compression rate
Time frame: 24h
percentage of chest compression without leaning
Time frame: 24h
percentage of chest compression with correct deep
Time frame: 24h
percentage of correct chest compression rate
Time frame: 24h
participants' fatigue (Borg's scale)
Time frame: 24h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clement BULEON, MD principal investigator
University Hospital of Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correct compression score (time frame: 24h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2014.