An observational study in Post-Anoxic Coma, sponsored by Rijnstate Hospital. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-26.
Sponsored by Rijnstate Hospital · Observational
Rationale: An important proportion of patients with return of spontaneous circulation (ROSC) after cardiac arrest remain comatose as a result of post anoxic encephalopathy (PAE). Specific treatments to promote cerebral recovery are lacking. Early identification of patients without potential of recovery of brain functioning may prevent inappropriate continuation of medical treatment and improve communication between doctors and families. Intensivists currently use a combination of diagnostic measures, including brainstem reflexes, motor response, status myoclonus, SSEP measurements and (increasingly) the EEG. However, together all these measure identify only 20-50% of the patients with severe PAE precluding cerebral recovery. At the moment, there is a high demand for bedside measurements that contribute to the neurological prognostication of comatose patients after cardiac arrest. Non-invasive bedside measurements of the optic nerve sheath diameter (ONSD) using ultrasound hold potential to improve outcome prediction.
Objective: To estimate the value and feasibility of repetitive measurements of the ONSD in comatose patients after cardiac arrest.
Study design: Prospective cohort study
Study population: 160 subsequent comatose adult patients after cardiac arrest, admitted to the ICU of Rijnstate hospital
Intervention: In addition to standard treatments, patients will undergo ultrasonic measurements of the ONSD during the first 3 days after cardiac arrest. Survivors will be followed upon hospital discharge. ONSD measurements will be followed over time and related tot neurological outcome.
Main study parameters/endpoints: The primary outcome measure is neurological outcome, defined using the Cerebral Performance Category (CPC) score at 6 months. CPC 1-2 indicates favourable neurological outcome, and CPC 3-5 indicates unfavourable neurological outcome.
966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.
This study's planned enrollment of 160 is below the median of 200 across 383 observational studies indexed under Heart Arrest.
Browse Heart Arrest studies →Rijnstate Hospital is the lead sponsor of 127 studies on the registry; 14 are open to participants now.
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160 subsequent comatose adult patients after cardiac arrest, admitted to the ICU of Rijnstate hospital.
Exclusion Criteria:
Ultrasonic measurement of the optic nerve sheath diameter
Glasgow Coma Scale
Neurological outcome, defined using the Cerebral Performance Category (CPC). CPC 1-2 indicates favourable neurological outcome, and CPC 3-5 indicates unfavourable neurological outcome.
Time frame: At 6 months after cardiac arrest
Plan to share: Undecided
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Rijnstate Hospital