Clinical trial NCT05321459: Predictive Outcome in Comatose Patients
Official title: New Predictive Tool of Awakening in Comatose Patients in the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coma
Heart Arrest
Cardiopulmonary Resuscitation
Keywords: Post cardiac arrest for comatose patients
Electroencephalography
Somatosensory evoked potentials
Auditory evoked potentials
Prognosis
Algorithms
Classification
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Ecole Normale Supérieure de Paris
First posted: 2022-04-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients admitted to intensive care following a cardica arrest.

Brief summary: 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.

Detailed description: Evaluating the prognosis of comatose participants after cardiac arrest (CA) in the intensive care unit remains challenging. It requires a multimodal approach combining standardized clinical examination, serum biomarkers, imaging and classically electrophysiological examinations: 1 / the electroencephalogram, bad prognosis assessed when the electroencephalogram (EEG) is discontinuous, areactive, monotone,...), 2 / somesthetic evoked potentials, the absence of the N20 cortical wave has a specificity of poor prognosis of 68-100% and 3 / auditory evoked potentials (AEP), the presence of mismatchnegativity (MMN) would be of good prognosis with a specificity up to 90% but rarely performed in current practice. Routinely, these examinations are sometimes difficult to interpret in sedated participants, in an intensive care unit environment that generates numerous artefacts. Above all, all these techniques require the presence of a neurophysiology unit, with few experts available.

In a preliminary study, in collaboration with the applied mathematics laboratory of the ENS (Ecole Normale Supérieure), an algorithm was developed from the signal extracted from AEP. A probability map was generated with a software allowing to visually classify the participants after processing signal by the algorithm in a cluster of points with a high specificity into "good neurological prognosis" and "bad neurological prognosis". Neither artifacts or sedation prevented data analysis.

The investigators hypothesize that the "PRECOM" tool, applied blindly to a large prospective multicenter cohort of participants admitted to intensive care for coma in the aftermath of a caridiac arrest will predict the neurological prognosis of participants with high sensitivity and specificity. This tool, carried out during the first week of the coma, will be compared to a standardized procedure used routinely by the participating resuscitators.

Eligibility criteria: 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 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

Primary outcomes:
measure: Awakening within 3 months
timeFrame: within 3 months ± 2 weeks after inclusion
Secondary outcomes:
measure: CPC score within 3 months
timeFrame: 3 months ± 2 weeks after inclusion
measure: mRS score within 3 months
timeFrame: 3 months ± 2 weeks after inclusion
measure: FOUR score within 3 months
timeFrame: 3 months ± 2 weeks after inclusion
measure: GOSE score within 3 months
timeFrame: 3 months ± 2 weeks after inclusion
measure: CPC score within 6 months
timeFrame: 6 months ± 2 weeks after inclusion
measure: mRS score within 6 months
timeFrame: within 6 months ± 2 weeks after inclusion
measure: GOSE score within 6 months
timeFrame: within 6 months ± 2 weeks after inclusion
measure: Awakening within 6 months ± 2 weeks
timeFrame: within 6 months ± 2 weeks after inclusion
measure: CRS-R score within 6 months
timeFrame: within 6 months ± 2 weeks after inclusion
measure: PRECOM tool - first week of coma
timeFrame: Inclusion visit (3 to 7 days after cardiac arrest +/- 2 days if week-end)
measure: PRECOM tool - second week of coma
timeFrame: One week visit (one week after inclusion visit +/- 2 days)
measure: PRECOM tool - first and second week of coma
timeFrame: Inclusion and one week visits
measure: Awakening - second week of coma
timeFrame: One week visit (one week after inclusion visit +/- 2 days)
measure: NSE blood marker
timeFrame: 3 days post cardiac arrest
measure: Glial blood markor
timeFrame: Inclusion visit (3 to 7 days after cardiac arrest +/- 2 days if week-end)
measure: Neuronal blood markor
timeFrame: Inclusion visit (3 to 7 days after cardiac arrest +/- 2 days if week-end)
measure: Inflammatory blood markor
timeFrame: Inclusion visit (3 to 7 days after cardiac arrest +/- 2 days if week-end)
Other outcomes:
Locations:
city: Bobigny
country: France
facility: APHP Avicenne Hospital - Réanimation médico-chirurgicale
city: Paris
country: France
facility: APHP Lariboisière Hospital, Clinical Physiology Department
city: Paris
country: France
facility: APHP Laribosière Hospital - Service de Réanimation Médical et Toxicologique
city: Paris
country: France
facility: APHP Cochin Hospital - médecine intensive-réanimation
city: Paris
country: France
facility: APHP HEGP hospital - Réanimation médicale
city: Paris
country: France
facility: APHP Bichat Hospital -Médecine intensive - réanimation infectieuse
city: Saint-Denis
country: France
facility: Delafontaine Hospital - médecine intensive-réanimation
Study officials:
affiliation: APHP Lariboisière Hospital, Clinical Physiology Department
name: Nathalie KUBIS, Md,PhD
role: STUDY_DIRECTOR
References: