Early Echographic Asystole as a Predictive Factor of Absence of Spontaneous Circulatory Activity Recovery (SCAR) in Prehospital Cardio Respiratory Arrests (CRA) (ACE)

Early Echographic Asystole as a Predictive Factor of Absence of Spontaneous Circulatory Activity Recovery (SCAR) in Prehospital Cardio Respiratory Arrests (CRA) - ACE Study

Assessment of prognostic performances of CCU in CRA Recovery (CRAR) has already been explored but 1) Only in intra-hospital medicine, 2) in very variable timings. ACE Research focuses on the extra-hospital window and predictive value of Early CCU (within 12 minutes of rescucitation initiation) with ambitious endpoints : curable etiologies identification, early anticipation of ECMO procedures, early anticipation of organ donation process, and evaluation of intrinsic contribution criterion to resuscitation interruption.

The primary objective of ACE study is to investigate the positive predictive value (PPV) of early ultrasound asystole on the absence of CRAR. The secondary objectives are multiple and innovative despite an observational design: impact on the morbi-mortality of the target population (frequency of curable etiologies, pre-therapeutic and therapeutic delays, morbidity...), delay of ECMO implementation of an ECMO (Extracorporeal Membrane Oxygenation), failure rate of organ donation due to overdelays, construction of a multifactorial score associated with CRAR.

Study Overview

• Status: Completed
• Conditions: Prehospital Cardio-Respiratory Arrests; Spontaneous Circulatory Activity Recovery
• Intervention / Treatment: Other: Non applicable - Non interventional study

Detailed Description

Prehospital Cardio-Respiratory Arrests (CRA) represent a significant cause of mortality in France (between 30,000 and 50,000 cases per year) [1]. The prognosis is particularly pejorative, since only 5 to 6% of patients will leave the hospital alive with satisfying neurological condition [2,3]. Their management in France is part of a very singular Primary Care System, based on the medicalization of medical regulation (SAMU) and effectiveness (SMUR) and is based mainly on European recommendations (cardiac massage, ventilation and cardiac rhythm analysis) [4]). European 2015 recommendations advocate for the use of Cardiac Clinical Ultrasound (CCU) in Emergency Medicine, particularly to identify curable causes of CRA. Indeed, CCU is likely to reveal various curable etiologies as tamponade, massive pulmonary embolism, deep hypovolemia or suffocating pneumothorax[5]. Their identification allows the clinician to better adjust his therapeutic strategy and consequently improve patient prognosis.

But its predictive value on the absence of Spontaneous Circulatory Activity Recovery (SCAR) focus clinicians' interest due to its impact on extracorporeal circulation procedures, organ donation or resuscitation interruption guideline. Several studies support the predictive value associated with the absence of mechanical cardiac activity and resuscitation failure [5-10]. However, proof level remains very shaky and transposition to prehospital medicine is clearly impossible (delays, management and environment differ largely). As a corollary, the European Resuscitation Council (ERC) ruled in 2015 that the prognostic performances of ultrasound asystole had not been sufficiently finely measured to consider it as a rigorous criterion for resuscitation interruption, appealing for pivotal studies [4].

ACE French National Trial fits precisely into this bibliographic gap. Our objectives are multiple: assess prognostic value of Early CCU (ECCU; ie. <M12), alone or combined with other clinical parameters (composite prognostic tool combining myocardial and/or electrical activity, capnography, No/Low Flow duration, and clinical profile -sex, age-) on the absence of SCAR ; describe frequency and typology of curable etiologies in the context of CRA, and estimate the possible prognostic impact of early CCU on morbidity and mortality; finally, in case of validation of its prognostic performances, estimate theoretical time savings on ECMO (Extracorporeal Membrane Oxygenation) and organ donation processes.

Multicentric, based on rigorous methodology, high proof-level design and large sample (N=624), ACE wants to be resolutely pragmatic, by associating peripheric hospital and university hospital (Expertise), urban or rural environment (delays and intervention conditions), in order to answer definitely clinicians questioning of the emergency physicians. Continuing in the same vein, we aim a future validation study of a decision-making algorithm for pre-hospital management of CRAs to reduce morbidity and (Randomized Cluster Study in Stepped-Wedge integrating a medico-economic component).

• Study Type: Observational
• Enrollment (Actual): 346

Contacts and Locations

• Study Contact: Name: Philippe PES, Dr; Phone Number: +33 2 53 48 28 35; Email: philippe.pes@chu-nantes.fr
• Study Contact Backup: Name: François Javaudin, Dr; Phone Number: +33 2 53 48 28 35; Email: françois.javaudin@chu-nantes.fr

Study Locations

• France
  • Angers, France, 49000
    • CHU Angers
  • Brest, France, 29609
    • CHRU Brest
  • Châteaubriant, France, 44036
    • Ch Chateaubriant
  • La Roche-sur-Yon, France, 85000
    • CHD Vendée
  • Nantes, France, 44093
    • Nantes University Hospital
  • Saint-Nazaire, France, 44600
    • CH Saint-Nazaire
  • Tours, France, 37000
    • CHRU Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All adult patients receiving resuscitation by the SMUR team in an CRA are eligible

Description

Inclusion Criteria:

• Adult (>18yo) presenting extra-hospital CRA.

Exclusion Criteria:

• Resuscitation refusal.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess prognostic value of early echographic (ECCU) asystole (i.e. within the first 12 minutes of resuscitation) on resuscitation failure (absence of CRAR).	Patient in CRAR with extra-hospital care	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess prognostic value of an early echographic (ECCU) asystole (i.e. within the first 12 minutes of resuscitation) on morbi-mortality evaluated at 30 days	Positive predictive value of ultrasound asystole within 12 minutes of the start of specialized CPR on the occurrence of death and/or sequelae at 30 days	1 month
Measure variations of the prognostic performances of the extra-hospital ECCU according to their timing of realization, on the absence of CRAR	Sensitive, specificity, negative predictive value, likelihood ratios of early ultrasound asystole to absence of CRAR	1 month
Study the link between ultrasound diagnosis and electrocardiogram electrical plots.	Recorded electrical activity patterns:	1 month
Creation of a multifactorial composite prognostic score associated with the absence of CRAR	composite score	1 month

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Study Director: Philippe Pes, Dr, Nantes University Hospital

Publications and helpful links

General Publications

• Javaudin F, Pes P, Montassier E, Legrand A, Ordureau A, Volteau C, Arnaudet I, Le Conte P. Early point-of-care focused echocardiographic asystole as a predictive factor for absence of return of spontaneous circulatory in out-of-hospital cardiac arrests: a study protocol for a prospective, multicentre observational study. BMJ Open. 2019 Aug 30;9(8):e027448. doi: 10.1136/bmjopen-2018-027448.

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2019
• Primary Completion (Actual): January 23, 2023
• Study Completion (Actual): January 23, 2023

Study Registration Dates

• First Submitted: March 29, 2018
• First Submitted That Met QC Criteria: March 29, 2018
• First Posted (Actual): April 11, 2018

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: RC17_0464

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No