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RECRUITING
NCT06979700

Early WAKE-up Predictors After Out-of-Hospital Cardiac Arrest

Sponsor: University of Aarhus

View on ClinicalTrials.gov

Summary

WAKE-OHCA is a prospective observational substudy of the Danish Out-of-Hospital Cardiac Arrest (DANOHCA) trial, identifier NCT05895838. The aim is to collect early neuromonitoring data to identify key predictors of successful wake-up.

Official title: Early Wake-up Predictors After Out-of-hospital Cardiac Arrest - an Observational, Multicenter Substudy of the DANOHCA Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

250

Start Date

2025-05-13

Completion Date

2027-12

Last Updated

2025-11-18

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Automated Pupillometry

Measurements will be performed on comatose participants at 0-6 hours, 20-28, 44-52 and 66-72 hours after enrolment for both pupils and include: Neurological pupil index, pupillary size, pupillary minimum diameter, pupillary constriction amplitude, pupillary constriction velocity, pupillary maximum constriction velocity, pupillary latency and pupillary dilation velocity.

DIAGNOSTIC_TEST

Transcranial Doppler Ultrasound

Measurements will be performed on comatose participants at 0-6 hours, 20-28, 44-52 and 66-72 hours after enrolment on both middle cerebral arteries and include the following: Peak systolic velocity, end diastolic velocity, mean velocity, pulsatility index and resistance index.

DIAGNOSTIC_TEST

Optic Nerve Sheath Diameter

Measurements will be performed on comatose participants at 0-6 hours, 20-28, 44-52 and 66-72 hours after enrolment on both eyes using ultrasound and include the following: optic nerve sheath diameter of right and left side and mean optic nerve sheath diameter.

DIAGNOSTIC_TEST

Continuous EEG and EEG Reactivity

Continuous 4-channel EEG will be established on participants as soon as possible within 0-6 hours. EEG will be stopped at successful extubation or when 72 hours has passed since study inclusion. EEG Reactivity will be performed on comatose participants at the following times: 0-6, 20-28, 44-52 and 66-72 hours after study inclusion. Reactivity includes 7 standardized stimuli, including 1 visual, 3 auditive and 3 pain stimuli. EEG data will be reviewed in Stratus EEG Analysis (Kvikna Mediacal ehf. version 5.1). Timestamps for EEG-reactivity will be manually inserted in the file. EEG Reactivity will be analysed quantitatively by power spectrum analyses performed in LabVIEW 2016 (National Instruments) according to the principles of a previous method (PMID: 36041343). Background activity within 5 minutes following reactivity stimuli, prioritizing time periods without artifacts, will be analysed by power spectrum analyses, Mindray quantitative analysis and manually analyzed by experts.

Locations (2)

Department of Intensive Care Medicine

Aarhus N, Denmark

Department of Cardiology, The Heart Centre, Rigshospitalet

Copenhagen, Denmark