Heart Arrest Clinical Trial
— PRECOMOfficial title:
New Predictive Tool of Awakening in Comatose Patients in the Intensive Care Unit
NCT number | NCT05321459 |
Other study ID # | AOR 20045 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 15, 2023 |
Est. completion date | May 29, 2026 |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | May 29, 2026 |
Est. primary completion date | March 1, 2026 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 ocular <3) and at the time of neurophysiological recordings (D3-D7 ± week -end). Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | APHP Avicenne Hospital - Réanimation médico-chirurgicale | Bobigny | |
France | APHP Bichat Hospital -Médecine intensive - réanimation infectieuse | Paris | |
France | APHP Cochin Hospital - médecine intensive-réanimation | Paris | |
France | APHP HEGP hospital - Réanimation médicale | Paris | |
France | APHP Lariboisière Hospital, Clinical Physiology Department | Paris | |
France | APHP Laribosière Hospital - Service de Réanimation Médical et Toxicologique | Paris | |
France | Delafontaine Hospital - médecine intensive-réanimation | Saint-Denis |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Ecole Normale Supérieure de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | within 3 months ± 2 weeks after inclusion | |
Secondary | 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). |
3 months ± 2 weeks after inclusion | |
Secondary | 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). |
3 months ± 2 weeks after inclusion | |
Secondary | 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. |
3 months ± 2 weeks after inclusion | |
Secondary | 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). |
3 months ± 2 weeks after inclusion | |
Secondary | CPC score within 6 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). |
6 months ± 2 weeks after inclusion | |
Secondary | mRS score within 6 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). |
within 6 months ± 2 weeks after inclusion | |
Secondary | GOSE score within 6 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). |
within 6 months ± 2 weeks after inclusion | |
Secondary | Awakening within 6 months ± 2 weeks | 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. The measurement takes place only if patient is still hospitalized. | within 6 months ± 2 weeks after inclusion | |
Secondary | CRS-R score within 6 months | CRS-R (Coma Recovery Scale - Revised) is a standardized neurobehavioral assessment measure designed for use in patients with disorders of consciousness. The scale is intented to be used to establish diagnosis, monitor behavioral recovery and predict outcome. It is performed only if patient is still hospitalized.
The total score ranges between 0 (worst) and 23 (best). |
within 6 months ± 2 weeks after inclusion | |
Secondary | PRECOM tool - first week of coma | Comparison of the ability of the PRECOM tool using clinical and electrophysiological data at inclusion (the first week of coma), to classify patients with good prognosis, poor prognosis and indeterminate prognosis with respect to this same categorization using the usual evaluation criteria performed routinely by participating resuscitations (clinical examination and EEG for all and evoked potentials in addition for some). | Inclusion visit (3 to 7 days after cardiac arrest +/- 2 days if week-end) | |
Secondary | PRECOM tool - second week of coma | Comparison of the ability of the PRECOM tool using clinical and electrophysiological data the second week of coma, to classify patients with good prognosis, poor prognosis and indeterminate prognosis with respect to this same categorization using the usual evaluation criteria performed routinely by participating resuscitations (clinical examination and EEG for all and evoked potentials in addition for some). | One week visit (one week after inclusion visit +/- 2 days) | |
Secondary | PRECOM tool - first and second week of coma | Comparison of the ability of the PRECOM tool using combinaison of clinical and electrophysiological data collected both at inclusion and one week later (the first two weeks of coma), to classify patients with good prognosis, poor prognosis and indeterminate prognosis with respect to this same categorization using the usual evaluation criteria performed routinely by participating resuscitations (clinical examination and EEG for all and evoked potentials in addition for some). | Inclusion and one week visits | |
Secondary | Awakening - second week of coma | 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. | One week visit (one week after inclusion visit +/- 2 days) | |
Secondary | NSE blood marker | Comparison of the ability to predict awakening with the PRECOM tool using the NSE blood marker (neuron- spécific enolase) collected 3 days after cardiac arrest between the patients awakened from the coma and those who are not. | 3 days post cardiac arrest | |
Secondary | Glial blood markor | Comparison of the ability to predict awakening with the PRECOM tool using the Glial Fibrillary Acidic Protein (GFAP) collected at the inclusion visit between the patients awakened from the coma and those who are not. | Inclusion visit (3 to 7 days after cardiac arrest +/- 2 days if week-end) | |
Secondary | Neuronal blood markor | Comparison of the ability to predict awakening with the PRECOM tool using the Neurofilament blood marker collected at the inclusion visit between the patients awakened from the coma and those who are not. | Inclusion visit (3 to 7 days after cardiac arrest +/- 2 days if week-end) | |
Secondary | Inflammatory blood markor | Comparison of the ability to predict awakening with the PRECOM tool using the inflammatory blood markers : Kynurenine and Tryptophan; collected at the inclusion visit between the patients awakened from the coma and those who are not. | Inclusion visit (3 to 7 days after cardiac arrest +/- 2 days if week-end) |
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