Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03494153 |
| Other study ID # |
RC17_0464 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 23, 2019 |
| Est. completion date |
January 23, 2023 |
Study information
| Verified date |
April 2023 |
| Source |
Nantes University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
