NCT03817892: CILICA-HS

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

Status unknown NA Last updated 22 March 2022

What this trial tests

NA trial testing Guidance of the External Chest Compression in Cardiac Arrest in 500 participants. Status unknown.

Timeline

1 December 2019

Primary endpoint
30 November 2024

1 January 2025

Quick facts

Lead sponsor	University Hospital, Caen
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	none
Primary purpose	other
Enrollment	500
Start date	1 December 2019
Primary completion	30 November 2024
Estimated completion	1 January 2025
Sites	11 locations across France

Drugs / interventions tested

• Guidance of the External Chest Compression
• Rhythm of a relay 4 minutes

Conditions studied

• Cardiac Arrest — all drugs for Cardiac Arrest →
• Cardiopulmonary Resuscitation — all drugs for Cardiopulmonary Resuscitation →

Sponsor

University Hospital, Caen

Who can join

18 and older, any sex, with Cardiac Arrest or Cardiopulmonary Resuscitation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Impacts of chest compression cycle length and real-time feedback with a CPRmeter® on chest compression quality in out-of-hospital cardiac arrest: study protocol for a multicenter randomized controlled factorial plan trial.
   Buléon C, Parienti JJ, Morilland-Lecoq E, Halbout L, et al · · 2020 · cited 4× · PMID 32641090 · DOI 10.1186/s13063-020-04536-3