Cardiac ArrestCILICA-QSNCT03140202
Compression Is Life In Cardiac Arrest - Quality Study (CILICA-QS)
A study testing CPRmeter (feedback device) with feedback and CPRmeter (feedback device) without feedback in people with Cardiac Arrest, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- CPRmeter (feedback device) with feedback and CPRmeter (feedback device) without feedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 18 Apr 2017to 1 Oct 2017
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Operational staff of University hospital of Caen pre-hospital unit
- Ability in CardioPulmonary Resuscitation
Who cannot join
- medical contraindication
- refusal
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital of Caen
Caen, Normandy, 14033
Clement BULEON, MD, +(33)231064736, buleon-c@chu-caen.fr
Christophe PERSYN, MD
About this study
Official title: 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.
Read more
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.
- Conditions
- Cardiac Arrest
- Being tested
- CPRmeter (feedback device) with feedback, CPRmeter (feedback device) without feedback
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPRmeter (feedback device) with feedbackDevice
Participants have a real time feedback and record.
CPRmeter (feedback device) without feedbackDevice
Participants have a real time record without feedback.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: CPRmeter (feedback device) with feedback; Device: 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). Receives: Device: CPRmeter (feedback device) with feedback; Device: CPRmeter (feedback device) without feedback |
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 (between 100/min and 120/min), depth (between 50 mm and 60 mm) and leaning (less than 2500g) at the same time
Measured: Day 0
Secondary outcomes (7)
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)
Measured: Day 0
Chest compression depth
Chest compression depth reached (in mm)
Measured: Day 0
Chest compression rate
Chest compression rate per min
Measured: Day 0
Percentage of chest compression without leaning
Percentage of chest compression without leaning defined with a residual weight egal or above 2500 g
Measured: Day 0
Percentage of chest compression with correct depth
Percentage of chest compression with depth between 50 mm and 60 mm
Measured: Day 0
Percentage of correct chest compression rate
Percentage chest compression rate between 100/min and 120/min
Measured: Day 0
Participants' fatigue (Borg's scale)
Participant auto-evaluation of fatigue with a predefined scale from 6 to 20 (no unit).
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start18 Apr 2017
- Primary completion15 Sep 2017 (estimated)
- Study completion1 Oct 2017 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clement BULEON, MD, Principal investigator, Medical Simulation Center Normandie Simulation en Sante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140202
- Sponsor's protocol ID
- A16-D51-VOL.30
- Acronym
- CILICA-QS
- Status last verified
- Apr 2017
- First submitted
- 24 Apr 2017
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. 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 Preservation During Cardio-pulmonary Resuscitation: A Manikin Study
- ClinicalTrials.gov ID
- NCT03140202
- Acronym / sponsor ID
- CILICA-QS / A16-D51-VOL.30
- Conditions
- Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 15 Sep 2017 (estimated)
- Study completion
- 1 Oct 2017 (estimated)
- First posted
- 4 May 2017 (actual)
- 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 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Guide then blind | Experimental | Device: CPRmeter (feedback device) with feedback, Device: CPRmeter (feedback device) without feedbackThis 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). |
| Blind then guide | Experimental | Device: CPRmeter (feedback device) with feedback, Device: CPRmeter (feedback device) without feedbackThis 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Operational staff of University hospital of Caen pre-hospital unit
- Ability in CardioPulmonary Resuscitation
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPRmeter (feedback device) with feedbackParticipants have a real time feedback and record. | Device | Blind then guide, Guide then blind |
| CPRmeter (feedback device) without feedbackParticipants have a real time record without feedback. | Device | Blind then guide, Guide then blind |
Primary outcome
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
7 secondary outcomes
Decrease time of 30% of correct compression score
Time frame: Day 0
Chest compression depth
Time frame: Day 0
Chest compression rate
Time frame: Day 0
Percentage of chest compression without leaning
Time frame: Day 0
Percentage of chest compression with correct depth
Time frame: Day 0
Percentage of correct chest compression rate
Time frame: Day 0
Participants' fatigue (Borg's scale)
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Individual participant dataSharing planned: No
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The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
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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
Medical Simulation Center Normandie Simulation en Sante
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPRmeter (feedback device) with feedback and CPRmeter (feedback device) without feedback in people with 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 2 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: status not confirmed, as of the sponsor's last update on 19 Jul 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clement BULEON, MD (+(33)231064736, buleon-c@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correct compression score (time frame: Day 0). 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 19 Jul 2017.