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

NCT03817892 | Unknown DMC

• 2 other identifiers: 2018-A02000-5517-248
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 11

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). The investigators propose a study evaluating the efficiency of the guidance of the ECC and the impact of the time of relay on the CCF. The investigators formulate two hypotheses that they 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 for whom specialized resuscitation is undertaken. The investigators 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.

Conditions

Cardiac Arrest; Cardiopulmonary Resuscitation

Keywords

No-Flow; Chest Compression Fraction; Out Hospital; External Chest Compression Relay; External Chest Compression Guidance; External Chest Compression Quality; Correct Compression Score

Outcome Measures

Primary Outcomes (2)

• Chest Compression Fraction

  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.

  1 day

• Correct Compression Score

  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) .

  1 day

Secondary Outcomes (11)

• Depth of External Chest Compression

  1 day

• Frequency of External Chest Compression

  1 day

• Relaxation of External Chest Compression

  1 day

• Subjective rescuers' fatigue

  1 day

• The delays and durations of care

  1 day

Other Outcomes (1)

• Demographic data

  Day 1

Study Arms (4)

Unguided 2 minutes (U2)

NO INTERVENTION

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.

Unguided 4 minutes (U4)

EXPERIMENTAL

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

Guided 2 minutes (G2)

EXPERIMENTAL

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

Guided 4 minutes (G4)

EXPERIMENTAL

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; Other: Rhythm of a relay 4 minutes

Interventions

Guidance of the External Chest Compression OTHER

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.

Also known as: CPRmeter's feedback

Guided 2 minutes (G2); Guided 4 minutes (G4)

Rhythm of a relay 4 minutes OTHER

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.

Guided 4 minutes (G4); Unguided 4 minutes (U4)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major person
• Victim of a cardiorespiratory arrest
• Affiliated to the social security system

You may not qualify if:

• 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.
• Traumatic cardiac arrest.
• Impossibility or contraindication to the use of the External Chest Compression guidance system.

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (11)

University Hospital of Caen

Caen, Normandy, 14033, France

RECRUITING

University Hospital of Amiens

Amiens, 80080, France

NOT YET RECRUITING

Hospital of Cherbourg - Louis Pasteur

Cherbourg, 50100, France

NOT YET RECRUITING

Hospital of Elbeuf Louviers Val de Reuil

Elbeuf, 76503, France

RECRUITING

Hospital Eure-Seine Evreux

Évreux, 27015, France

RECRUITING

Hospital of Le Havre -

Le Havre, 76290, France

NOT YET RECRUITING

University Hospital of Lille

Lille, 59000, France

NOT YET RECRUITING

Hospital of Lisieux - Robert Bisson

Lisieux, 14100, France

NOT YET RECRUITING

University Hospital of Lyon

Lyon, 69003, France

NOT YET RECRUITING

University Hospital of Rouen

Rouen, 76000, France

NOT YET RECRUITING

Hospital of Valenciennes

Valenciennes, 59300, France

NOT YET RECRUITING

Related Publications (17)

• International Liaison Committee on Resuscitation. 2005 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Part 4: Advanced life support. Resuscitation. 2005 Nov-Dec;67(2-3):213-47. doi: 10.1016/j.resuscitation.2005.09.018. No abstract available.

  PMID: 16324990 BACKGROUND

• Nolan JP, Soar J, Zideman DA, Biarent D, Bossaert LL, Deakin C, Koster RW, Wyllie J, Bottiger B; ERC Guidelines Writing Group. European Resuscitation Council Guidelines for Resuscitation 2010 Section 1. Executive summary. Resuscitation. 2010 Oct;81(10):1219-76. doi: 10.1016/j.resuscitation.2010.08.021. No abstract available.

  PMID: 20956052 BACKGROUND

• Monsieurs KG, Nolan JP, Bossaert LL, Greif R, Maconochie IK, Nikolaou NI, Perkins GD, Soar J, Truhlar A, Wyllie J, Zideman DA; ERC Guidelines 2015 Writing Group. European Resuscitation Council Guidelines for Resuscitation 2015: Section 1. Executive summary. Resuscitation. 2015 Oct;95:1-80. doi: 10.1016/j.resuscitation.2015.07.038. Epub 2015 Oct 15. No abstract available.

  PMID: 26477410 BACKGROUND

• Christenson J, Andrusiek D, Everson-Stewart S, Kudenchuk P, Hostler D, Powell J, Callaway CW, Bishop D, Vaillancourt C, Davis D, Aufderheide TP, Idris A, Stouffer JA, Stiell I, Berg R; Resuscitation Outcomes Consortium Investigators. Chest compression fraction determines survival in patients with out-of-hospital ventricular fibrillation. Circulation. 2009 Sep 29;120(13):1241-7. doi: 10.1161/CIRCULATIONAHA.109.852202. Epub 2009 Sep 14.

  PMID: 19752324 BACKGROUND

• Wik L, Olsen JA, Persse D, Sterz F, Lozano M Jr, Brouwer MA, Westfall M, Souders CM, Travis DT, Herken UR, Lerner EB. Why do some studies find that CPR fraction is not a predictor of survival? Resuscitation. 2016 Jul;104:59-62. doi: 10.1016/j.resuscitation.2016.04.013. Epub 2016 May 4.

  PMID: 27155547 BACKGROUND

• Berg RA, Sanders AB, Kern KB, Hilwig RW, Heidenreich JW, Porter ME, Ewy GA. Adverse hemodynamic effects of interrupting chest compressions for rescue breathing during cardiopulmonary resuscitation for ventricular fibrillation cardiac arrest. Circulation. 2001 Nov 13;104(20):2465-70. doi: 10.1161/hc4501.098926.

  PMID: 11705826 BACKGROUND

• Cunningham LM, Mattu A, O'Connor RE, Brady WJ. Cardiopulmonary resuscitation for cardiac arrest: the importance of uninterrupted chest compressions in cardiac arrest resuscitation. Am J Emerg Med. 2012 Oct;30(8):1630-8. doi: 10.1016/j.ajem.2012.02.015. Epub 2012 May 23.

  PMID: 22633716 BACKGROUND

• Kleinman ME, Brennan EE, Goldberger ZD, Swor RA, Terry M, Bobrow BJ, Gazmuri RJ, Travers AH, Rea T. Part 5: Adult Basic Life Support and Cardiopulmonary Resuscitation Quality: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S414-35. doi: 10.1161/CIR.0000000000000259. No abstract available.

  PMID: 26472993 BACKGROUND

• 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, Grasner 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.

  PMID: 25438254 BACKGROUND

• Cheskes S, Schmicker RH, Rea T, Morrison LJ, Grunau B, Drennan IR, Leroux B, Vaillancourt C, Schmidt TA, Koller AC, Kudenchuk P, Aufderheide TP, Herren H, Flickinger KH, Charleston M, Straight R, Christenson J; ROC investigators. The association between AHA CPR quality guideline compliance and clinical outcomes from out-of-hospital cardiac arrest. Resuscitation. 2017 Jul;116:39-45. doi: 10.1016/j.resuscitation.2017.05.003. Epub 2017 May 2.

  PMID: 28476474 BACKGROUND

• Hostler D, Everson-Stewart S, Rea TD, Stiell IG, Callaway CW, Kudenchuk PJ, Sears GK, Emerson SS, Nichol G; Resuscitation Outcomes Consortium Investigators. Effect of real-time feedback during cardiopulmonary resuscitation outside hospital: prospective, cluster-randomised trial. BMJ. 2011 Feb 4;342:d512. doi: 10.1136/bmj.d512.

  PMID: 21296838 BACKGROUND

• Buleon C, Delaunay J, Parienti JJ, Halbout L, Arrot X, Gerard JL, Hanouz JL. Impact of a feedback device on chest compression quality during extended manikin CPR: a randomized crossover study. Am J Emerg Med. 2016 Sep;34(9):1754-60. doi: 10.1016/j.ajem.2016.05.077. Epub 2016 May 28.

  PMID: 27349359 BACKGROUND

• Goodloe JM, Idris AH. Metrics save lives: value and hurdles faced. Curr Opin Crit Care. 2017 Jun;23(3):204-208. doi: 10.1097/MCC.0000000000000408.

  PMID: 28379867 BACKGROUND

• Lin S, Scales DC. Cardiopulmonary resuscitation quality and beyond: the need to improve real-time feedback and physiologic monitoring. Crit Care. 2016 Jun 28;20(1):182. doi: 10.1186/s13054-016-1371-9.

  PMID: 27349642 BACKGROUND

• Cheskes S, Byers A, Zhan C, Verbeek PR, Ko D, Drennan IR, Buick JE, Brooks SC, Lin S, Taher A, Morrison LJ; Rescu Epistry Investigators. CPR quality during out-of-hospital cardiac arrest transport. Resuscitation. 2017 May;114:34-39. doi: 10.1016/j.resuscitation.2017.02.016. Epub 2017 Feb 24.

  PMID: 28242210 BACKGROUND

• Wallace SK, Abella BS, Becker LB. Quantifying the effect of cardiopulmonary resuscitation quality on cardiac arrest outcome: a systematic review and meta-analysis. Circ Cardiovasc Qual Outcomes. 2013 Mar 1;6(2):148-56. doi: 10.1161/CIRCOUTCOMES.111.000041. Epub 2013 Mar 12.

  PMID: 23481533 BACKGROUND

• Buleon C, Parienti JJ, Morilland-Lecoq E, Halbout L, Cesareo E, Dubien PY, Jardel B, Boyer C, Husson K, Andriamirado F, Benet X, Morel-Marechal E, Aubrion A, Muntean C, Dupire E, Roupie E, Hubert H, Vilhelm C, Gueugniaud PY; CILICA-HS study group. Impacts of chest compression cycle length and real-time feedback with a CPRmeter(R) on chest compression quality in out-of-hospital cardiac arrest: study protocol for a multicenter randomized controlled factorial plan trial. Trials. 2020 Jul 8;21(1):627. doi: 10.1186/s13063-020-04536-3.

  PMID: 32641090 DERIVED

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Clément BULEON, MD

  University Hospital of Caen

  PRINCIPAL INVESTIGATOR

• Pierre-Yves GUEUGNIAUD, MD, PhD

  University Hospital of Lyon

  STUDY CHAIR

• Eric ROUPIE, MD, PhD

  University Hospital of Caen

  STUDY CHAIR

Central Study Contacts

Clément BULEON, MD

CONTACT

+33(0)231064736; buleon-c@chu-caen.fr

Laurent HALBOUT, MD

CONTACT

+33(0)231063400; halbout-l@chu-caen.fr

Study Design

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

Model Details: 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).

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: January 28, 2019
• Study Start: December 1, 2019
• Primary Completion: November 30, 2024
• Study Completion: January 1, 2025
• Last Updated: March 22, 2022

Record last verified: 2022-03

Locations

FR (11)