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

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ClinicalTrials.gov Identifier: NCT03494153
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment
Prehospital Cardio-Respiratory Arrests Spontaneous Circulatory Activity Recovery 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).

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Study Type : Observational
Estimated Enrollment : 624 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Echographic Asystole as a Predictive Factor of Absence of Spontaneous Circulatory Activity Recovery (SCAR) in Prehospital Cardio Respiratory Arrests (CRA) - ACE Study
Actual Study Start Date : January 23, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest


Intervention Details:
  • Other: Non applicable - Non interventional study
    Non interventional study


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


Secondary Outcome Measures :
  1. 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 [ Time Frame: 1 month ]
    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

  2. Measure variations of the prognostic performances of the extra-hospital ECCU according to their timing of realization, on the absence of CRAR [ Time Frame: 1 month ]
    Sensitive, specificity, negative predictive value, likelihood ratios of early ultrasound asystole to absence of CRAR

  3. Study the link between ultrasound diagnosis and electrocardiogram electrical plots. [ Time Frame: 1 month ]
    Recorded electrical activity patterns:

  4. Creation of a multifactorial composite prognostic score associated with the absence of CRAR [ Time Frame: 1 month ]
    composite score



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
All adult patients receiving resuscitation by the SMUR team in an CRA are eligible
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Resuscitation refusal.

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): NCT03494153


Contacts
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Contact: Philippe PES, Dr 2 53 48 28 35 ext +33 philippe.pes@chu-nantes.fr
Contact: François Javaudin, Dr 2 53 48 28 35 ext +33 françois.javaudin@chu-nantes.fr

Locations
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France
Chu Angers Recruiting
Angers, France, 49000
Contact: Patrick MIROUX, ph    07 86 49 06 18    patrick.miroux@yahoo.fr   
Chru Brest Recruiting
Brest, France, 29609
Contact: Emgan QUERELLOU, ph    02 98 34 74 50    emgan.qurellou@chu-brest.fr   
Ch Chateaubriant Recruiting
Châteaubriant, France, 44036
Contact: Tanguy PELUCHON, ph    02 40 55 88 01    tanpelu@yahoo.fr   
Chd Vendee Recruiting
La Roche-sur-Yon, France, 85000
Contact: François BRAU, ph    02 51 44 61 61    francois.brau@chd-vendee.fr   
Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: Philippe PES, Dr         
CH Saint-Nazaire Recruiting
Saint-Nazaire, France, 44600
Contact: Mathieu THIBAULT, ph    02 72 27 81 74    m.thibault@ch-saintnazaire.fr   
Chru Tours Recruiting
Tours, France, 37000
Contact: Saïd LARIBI, ph    02 47 36 62 37    s.laribi@chu-tours.fr   
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Study Director: Philippe Pes, Dr Nantes University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03494153    
Other Study ID Numbers: RC17_0464
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Apnea
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory