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Compression Is Life In Cardiac Arrest - Human Study (CILICA-HS). (CILICA-HS)

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ClinicalTrials.gov Identifier: NCT03817892
Recruitment Status : Not yet recruiting
First Posted : January 28, 2019
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Brief Summary:

The management of out-of-hospital cardiac arrest is complex and multifactorial. With an incidence between 5 and 15 per 10,000 (46,000 patients per year in France) and a survival rate of only 5% to 15%, the room for improvement remains significant even today and is based on fast and optimal care. Thus French and international recommendations insist on the central element of external chest compression (ECC) and especially its quality (Monsieurs KG and Al. Resuscitation 2015; 95: 1-80). Improving the chest compression fraction (CCF) by limiting time without cardiac massage (No-Flow) is a second major point of the recommendations (Vaillancourt C and Al. Resuscitation 2011; 82: 1501-7). The survival of cardiac arrest victims is closely related on this No-Flow time. The principle of the chain of survival (early warning - ECC - defibrillation - resuscitation) implies that the deterioration of a single link threaten the whole of the care. To meet these qualitative needs, ECC guidance devices have been developed. They make possible to improve the quality of the ECC achieved (Hostler D and Al. BMJ 2011; 342d512). Their use is one of the areas of improvement mentioned in the recommendations. Our team studied in simulation the prolonged effects of guidance on the quality of the ECC during a prolonged resuscitation, with encouraging results (Buléon C and Al. Am J Emerg Med 2016; 34: 1754-60). We propose a study evaluating the efficiency of the guidance of the ECC and the impact of the time of relay on the CCF. We formulate two hypotheses that we wish to test simultaneously using a 2x2 factorial design, in a multicenter randomized trial. The first assumption is that a 4-minute relay rate improves the CCF (by reducing the No-Flow time) compared to the currently recommended 2-minute relay rate. The second hypothesis is that a guiding device improves the quality of the ECC.

This study should, over a period of 2 years, include 500 patients with cardiac arrest in front of witnesses for whom specialized resuscitation is undertaken. We hope by this study to improve the knowledge on the optimal rhythm of the ECC and to validate "in vivo" the interest for the guidance found on manikin. This study should make it possible to clarify the recommendations with a high level of evidence in this field and thus contribute to improving the prognosis of the victims of an out-of-hospital cardiac arrest.


Condition or disease Intervention/treatment Phase
Cardiac Arrest Cardiopulmonary Resuscitation Other: Guidance of the External Chest Compression Other: Rhythm of a relay 4 minutes Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: This is a randomized, multicenter, open-label study using a 2x2 factorial design comparing (i) the rhythm of External Chest Compression relays every 4 minutes versus every 2 minutes on the Chest Compression Fraction; (ii) the use of real-time guidance of the External Chest Compression via a feedback device (CPRmeter®) versus no guidance on the quality of the External Chest Compression (correct compression score).
Masking: None (Open Label)
Masking Description: The participants being in cardiac arrest at the time of the performance of the study, they are not aware of the arm of randomization in which they are initialy and they are inform as soon as their clinical status allow it.
Primary Purpose: Other
Official Title: Assessment of the Impact of Relay Timing and CPRmeter Guidance on the Quality of External Chest Compression: Compression Is Life In Cardiac Arrest - Human Study (CILICA-HS).
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : March 3, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

Arm Intervention/treatment
No Intervention: Unguided 2 minutes (U2)

The External Chest Compression are performed without guidance of the CPRmeter device (according to the current guidelines).

The duration or rhythm of a relay during which a rescuer performs External Chest Compression before being relayed by another rescuer is 2 minutes according to the current guidelines.

Experimental: Unguided 4 minutes (U4)

The External Chest Compression are performed without guidance of the CPRmeter device (according to the current guidelines).

The duration or rhythm of a relay during which a rescuer performs External Chest Compression before being relayed by another rescuer is 4 minutes. (Rhythm of a relay 4 minutes)

Other: Rhythm of a relay 4 minutes
The duration or rhythm of a relay is the time during which a rescuer performs External Chest Compression before being relayed by another rescuer. This time is 2 minutes in non intervention group according to the current guidelines and 4 minutes in experimental group.

Experimental: Guided 2 minutes (G2)
The External Chest Compression are performed with guidance of the CPRmeter device. (Guidance of the External Chest Compression) The duration or rhythm of a relay during which a rescuer performs External Chest Compression before being relayed by another rescuer is 2 minutes according to the current guidelines.
Other: Guidance of the External Chest Compression
The CPRmeter® device is positioned on the patient's chest with a disposable adhesive. In the situation of guidance of the External Chest Compression the rescuers have access in real time on the screen to visual feedback on the quality of the External Chest Compression performed and indications of possible corrections to improve the quality of the External Chest Compression . In the case of non-guidance of the External Chest Compression , a mask is position on the screen in order to hide the feedback information.
Other Name: CPRmeter's feedback

Experimental: Guided 4 minutes (G4)
The External Chest Compression are performed with guidance of the CPRmeter device. (Guidance of the External Chest Compression) The duration or rhythm of a relay during which a rescuer performs External Chest Compression before being relayed by another rescuer is 4 minutes. (Rhythm of a relay 4 minutes)
Other: Guidance of the External Chest Compression
The CPRmeter® device is positioned on the patient's chest with a disposable adhesive. In the situation of guidance of the External Chest Compression the rescuers have access in real time on the screen to visual feedback on the quality of the External Chest Compression performed and indications of possible corrections to improve the quality of the External Chest Compression . In the case of non-guidance of the External Chest Compression , a mask is position on the screen in order to hide the feedback information.
Other Name: CPRmeter's feedback

Other: Rhythm of a relay 4 minutes
The duration or rhythm of a relay is the time during which a rescuer performs External Chest Compression before being relayed by another rescuer. This time is 2 minutes in non intervention group according to the current guidelines and 4 minutes in experimental group.




Primary Outcome Measures :
  1. Chest Compression Fraction [ Time Frame: 1 day ]
    The Chest Compression Fraction (in percentage) corresponds to the resuscitation time during which a External Chest Compression is performed (Low Flow) related to the patient's management time by the prehospital rescue team.

  2. Correct Compression Score [ Time Frame: 1 day ]
    The correct compression score (in percentage) corresponds to a External Chest Compression for which simultaneously the depth is correct (50 to 60 mm), the frequency is correct (100 to 120 / min) and the relaxation is correct (<2500 g) .


Secondary Outcome Measures :
  1. Depth of External Chest Compression [ Time Frame: 1 day ]
    The depth of External Chest Compression (in millimeters) continuously recorded by the guidance system (average and percentage correct).

  2. Frequency of External Chest Compression [ Time Frame: 1 day ]
    The frequency of External Chest Compression (in number of compression per minute) recorded continuously by the guidance system (average and percentage correct)....

  3. Relaxation of External Chest Compression [ Time Frame: 1 day ]
    The relaxation of External Chest Compression corresponds to the residual force (in grams) recorded continuously by the guidance system (average and percentage correct)

  4. Subjective rescuers' fatigue [ Time Frame: 1 day ]
    The subjective fatigue assessed by rescuers who performed External Chest Compression using the Borg scale (average of the Borg Scale values of rescuers)

  5. The delays and durations of care [ Time Frame: 1 day ]
    The delays and durations of care (in minutes and seconds) based on the following events: cardiac arrest time, start time of the External Chest Compression, start time of resuscitation by the prehospital rescue team, end time of resuscitation (ROSC or death of the patient).

  6. No-Flow and Low-Flow times [ Time Frame: 1 day ]
    The times (in minutes and seconds) of No-Flow (time during which no External Chest Compression is performed) and Low-Flow (time during which External Chest Compression is performed, generating a minimum flow rate of organs).

  7. Recuperation of Spontaneous Circulation [ Time Frame: 1 day ]
    The rate of Recuperation of Spontaneous Circulation (percentage).

  8. survival at hospital arrival [ Time Frame: 1 day ]
    The rate of survival at hospital arrival

  9. Neuron Specific Enolase [ Time Frame: Day 1 and day 3 ]
    The serum Neuron Specific Enolase level (ng/mL)

  10. Survival [ Time Frame: Day 2 and one month. ]
    The survival rate.

  11. Cerebral Performance Category Score [ Time Frame: up to one month. ]
    Cerebral Performance Category Score as discribe in Wijdicks EFM et al. Neurology 2006;67:203-10.


Other Outcome Measures:
  1. Demographic data [ Time Frame: Day 1 ]
    Demographic data of the population (sexe, age, suspect cause of cardiac arrest, etc)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major person
  • Victim of a cardiorespiratory arrest in the presence of a witness
  • Eligible for inclusion procedure in immediate life emergency
  • Delay between the onset of cardiac arrest and the start of medical resuscitation less than or equal to 20 minutes
  • Affiliated to the social security system

Exclusion Criteria:

  • Minor person.
  • Pregnant woman over 6 months old or breastfeeding.
  • Known incurable disease.
  • Palliative care in progress.
  • Decision not to resuscitate from the patient (anticipated directives) or from the medical team.
  • Cardiac arrest without witness.
  • Traumatic cardiac arrest.
  • Impossibility or contraindication to the use of the External Chest Compression guidance system.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03817892


Contacts
Contact: Clément BULEON, MD +33(0)231064736 buleon-c@chu-caen.fr
Contact: Laurent HALBOUT, MD +33(0)231063400 halbout-l@chu-caen.fr

Locations
France
University Hospital of Caen Not yet recruiting
Caen, Normandy, France, 14033
Contact: Clement BULEON, MD    +(33)231064736    buleon-c@chu-caen.fr   
Sub-Investigator: Laurent HALBOUT, MD         
Sub-Investigator: Xavier ARROT, MD         
University Hospital of Amiens Not yet recruiting
Amiens, France, 80080
Contact: Christophe BOYER, MD       boyer.christophe@chu-amiens.fr   
Hospital of Cherbourg - Louis Pasteur Not yet recruiting
Cherbourg, France, 50100
Contact: Catalin MUNTEAN, MD       c.muntean@ch-cotentin.fr   
Hospital of Elbeuf Louviers Val de Reuil Not yet recruiting
Elbeuf, France, 76503
Contact: Emmanuel MOREL-MARECHAL, MD       emmanuel.morelmarechal@chi-elbeuf-louviers.fr   
Hospital of Le Havre - Not yet recruiting
Le Havre, France, 76290
Contact: Xavier BENET, MD       xav.benet@gmail.com   
University Hospital of Lille Not yet recruiting
Lille, France, 59000
Contact: Kevin HUSSON, MD       husson.k@gmail.com   
Hospital of Lisieux - Robert Bisson Not yet recruiting
Lisieux, France, 14100
Contact: Antoine AUBRION, MD       aubrion.antoine@gmail.com   
University Hospital of Lyon Not yet recruiting
Lyon, France, 69003
Contact: Eric CESAREO, MD       eric.cesareo@chu-lyon.fr   
University Hospital of Rouen Not yet recruiting
Rouen, France, 76000
Contact: Benoit JARDEL, MD       benoit.jardel@chu-rouen.fr   
Hospital of Valenciennes Not yet recruiting
Valenciennes, France, 59300
Contact: Carine VANDERSTRAETEN, MD       vanderstraeten-c@ch-valenciennes.fr   
Hospital Eure-Seine Evreux Not yet recruiting
Évreux, France, 27015
Contact: Florian ANDRIRAMIRADO, MD       florian.andriamirado@chi-eureseine.fr   
Sponsors and Collaborators
University Hospital, Caen
Investigators
Principal Investigator: Clément BULEON, MD University Hospital of Caen
Study Chair: Pierre-Yves GUEUGNIAUD, MD, PhD University Hospital of Lyon
Study Chair: Eric ROUPIE, MD, PhD University Hospital of Caen

Publications:
Perkins GD, Jacobs IG, Nadkarni VM, Berg RA, Bhanji F, Biarent D, Bossaert LL, Brett SJ, Chamberlain D, de Caen AR, Deakin CD, Finn JC, Gräsner JT, Hazinski MF, Iwami T, Koster RW, Lim SH, Ma MH, McNally BF, Morley PT, Morrison LJ, Monsieurs KG, Montgomery W, Nichol G, Okada K, Ong ME, Travers AH, Nolan JP; Utstein Collaborators. Cardiac Arrest and Cardiopulmonary Resuscitation Outcome Reports: Update of the Utstein Resuscitation Registry Templates for Out-of-Hospital Cardiac Arrest: A Statement for Healthcare Professionals From a Task Force of the International Liaison Committee on Resuscitation (American Heart Association, European Resuscitation Council, Australian and New Zealand Council on Resuscitation, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Council of Southern Africa, Resuscitation Council of Asia); and the American Heart Association Emergency Cardiovascular Care Committee and the Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation. Resuscitation. 2015 Nov;96:328-40. doi: 10.1016/j.resuscitation.2014.11.002. Epub 2014 Nov 11.

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03817892     History of Changes
Other Study ID Numbers: 2018-A02000-55
17-248 ( Other Identifier: CHU Caen )
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Caen:
No-Flow
Chest Compression Fraction
Out Hospital
External Chest Compression Relay
External Chest Compression Guidance
External Chest Compression Quality
Correct Compression Score

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases