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

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.

Conditions

• Cardiac Arrest (CA)
• Anoxic Brain Injury
• Comatose Survivors of Cardiac Arrest
• EEG
• Pupillometry
• Optic Nerve Sheath Diameter
• Transcranial Doppler Ultrasound
• Neurological Outcome

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.

Sponsors & Collaborators

• Aarhus University Hospital

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• University of Aarhus

  lead OTHER

Principal Investigators

• Christian Hassager, MD, DMSc · Department of Cardiology, Rigshospitalet

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-13

Primary Completion

2027-09-30

Completion

2027-12-31

Countries

• Denmark

Study Locations