Predictive Outcome in Comatose Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
Evaluating the prognosis of comatose patients after cardiac arrest (CA) in the intensive care unit (ICU) remains challenging. It requires a multimodal approach combining standardized clinical examination, serum biomarkers, imaging and classically electrophysiological examinations, (among them auditive evoked potentials or AEP) but none has a sufficient sensitivity/specificity. In a preliminary study, the investigators developed an algorithm from the signal collected with AEP, and generated a probability map to visually classify the participants after the algorithm processing. Participants could be classified either with a good neurological prognosis or with bad neurological prognosis or death.
The investigators hypothesize that the "PRECOM" tool, applied blindly to a large prospective multicenter cohort of patients admitted to intensive care for coma in the aftermath of CA will predict neurological prognosis at 3 months with high sensitivity and specificity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age above18 years old
Patient affiliated to a French Heath Care Insurance
Admitted in the intensive care unit (ICU) for coma post extra- or intra-hospital cardiac arrest (CA) with shockable or non-shockable rhythm
Persistent coma on day 3 after post CA, defined by the inability to respond to a verbal command in an appropriate manner (motor Glasgow components ≤ 3) and at the time of neurophysiological recordings (D3-D7 ± week -end).
Disqualifiers
Decision to limit resuscitation therapies taken by the resuscitation team
Inability to perform the auditory evoked potentials (AEP) (deafness, skin lesion or any condition preventing to record AEP).
Opposition by the trusted person or by the patient once he/she wakes up
Trial population
Adult patients admitted to intensive care following a cardica arrest.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Neurological prognosis
Other interventionIn usual practice, in intensive care unit, evaluating the neurological prognosis of comatose patients after cardiac arrest requires a multimodal approach combining standardized clinical examination, serum biomarkers, imaging and classically electrophysiological examinations (among them auditive evoked potentials or AEP). An algorithm (PRECOM tool) which has been previously developed from the signal extracted from AEP allows to visually classify the patients after processing signal by the algorithm in a cluster of points with a high specificity into "good neurological prognosis" and "bad neurological prognosis". The AEP signals recorded in the 1st and 2nd week of patient inclusion are to be collected by the neurophysiologist. At the end of the patient's participation in the study, these data will be encrypted, anonymized and transmitted to the mathematician to be processed by the PRECOM tool.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Comatose patients in intensive care unit1 intervention
Trial outcomes
Primary outcomes
1
Awakening within 3 months
Awakening is defined as normal motor activity in response to the 3 instructions for the motor component M of the FOUR score (show your thumb, make the V for victory and show your fist; M = 4). This criterion will be collected by the doctor in charge of the patient at the time of the assessment and will be dated.
Time frame
within 3 months ± 2 weeks after inclusionSecondary outcomes
1
CPC score within 3 months
CPC (Cerebral Performance Category) score is performed wether patient is still hospitalized or returned home. It is performed by phone call if patient returned home. Range of values rates neurological status after cardiac arrest on a scale of 1 to 5 (1 for good cerebral performance up to 5 for brain death).
Time frame
3 months ± 2 weeks after inclusion2
mRS score within 3 months
mRS (Modified Rankin Scale) scores is performed wether patient is still hospitalized or returned home. It is performed by phone call if patient returned home. mRS (modified Rankin Scale) scale measures degree of disability/dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Score can be between 0 (no symptoms at all) and 5 (major disability : bedridden, incontinent and requiring constant nursing care and attention).
Time frame
3 months ± 2 weeks after inclusion3
FOUR score within 3 months
FOUR (Full Outline of UnResponsiveness) score is performed only if patient is still hospitalized (being awake or not). FOUR score is a grading scale for assessing the level of consciousness performed on patients with severe neurologic impairment..It addresses four domains of neurological functioning: Eye response; Motor response ; Brainstem score and Respiratory score. Score is ranging from 0 to 16 where the lower the score, the greater the coma gravity.
Time frame
3 months ± 2 weeks after inclusion4
GOSE score within 3 months
GOSE (Extended Glasgow Outcome Scale) score is performed wether patient is still hospitalized or returned home. GOSE score classifies global outcomes in traumatic brain injury survivors. It rates patient status into one of eight categories ranging from 8 (Upper good recovery) to 1 (Dead).
Time frame
3 months ± 2 weeks after inclusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Assistance Publique - Hôpitaux de Paris
Lead sponsor
Ecole Normale Supérieure de Paris
Collaborator
Source ClinicalTrials.gov