Ultrasonic Measurement of the Optic Nerve Sheath Diameter Predicting Outcome After Cardiac Arrest

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-02

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prognostic Value With Combined ONSD and NIRS Measurements for Predicting Neurological Outcome After Cardiac Arrest

NCT05552794

Cardiac Arrest

COMPLETED

Differential Diagnosis and Cause-specific Treatment During OHCA

NCT04670354

Out-Of-Hospital Cardiac Arrest

UNKNOWN

The Use of a Point-of-care Thoracic Ultrasound Protocol for Hospital Medical Emergency Teams

NCT03214809

Dyspnea Coma Hypotension and Shock

TERMINATED NA

Pre-hospital Post ROSC Care: Are we Achieving Our Targets?

NCT04339257

Out-Of-Hospital Cardiac Arrest Post Cardiac Arrest Syndrome Emergency Medical Services

UNKNOWN

Initial Volume Status in Patients With Acute Brain Injury is Associated With Neurological Prognosis

NCT06090812

Acute Brain Injury Paroxysmal Sympathetic Hyperactivity Volume Status +3 more

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post-Anoxic Coma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ultrasound

Ultrasonic measurement of the optic nerve sheath diameter

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age ≥ 18 years
* Cardiac arrest
* Admitted to the ICU with Glasgow Coma Scale ≤ 8

Exclusion Criteria

* Pregnancy
* Traumatic head injury
* Eye surgery in medical history, including cataract surgery
* Pre-existing dependency in daily living (CPC 3 or 4)
* Any known progressive brain illness, such as a brain tumour or neurodegenerative disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No