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.
Age ≥18 years
OHCA of presumed cardiac cause
Sustained ROSC, defined as persistent signs of circulation and no need for chest compressions or mechanical circulatory support for 20 minutes
Unconsciousness (GCS <9) (patients not able to obey verbal commands) after sustained ROSC at the time of randomization
Females of childbearing potential if pregnancy is suspected (unless a negative HCG test can rule out pregnancy within the inclusion window)
Known bleeding diathesis (medically induced coagulopathy (e.g. warfarin, NOAC, clopidogrel) does not exclude the patient)
Suspected or confirmed acute intracranial bleeding
Suspected or confirmed acute stroke
Patients enrolled in the DANOHCA trial at Aarhus University Hospital and Rigshospitalet.
Cohort
Prospective
Automated Pupillometry
Diagnostic testMeasurements 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.
Transcranial Doppler Ultrasound
Diagnostic testMeasurements 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.
Optic Nerve Sheath Diameter
Diagnostic testMeasurements 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.
Continuous EEG and EEG Reactivity
Diagnostic testContinuous 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.
Number of patients with successful wake-up
Defined as awake and successfully extubated.
Number of patients with successful delayed wake-up
Defined as awake and successfully extubated later than according to DANOHCA randomization.
Duration of intubation
Assessed as the duration of intubation from randomization till extubation during initial ICU stay (oral and tracheostomy combined).
Days alive outside hospital
Counted as days alive outside of hospital after discharge.
30-day mortality
Number of patients dying from all causes.
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University of Aarhus
Lead sponsor
Aarhus University Hospital
Collaborator
Rigshospitalet, Denmark
Collaborator
