UnknownNot Applicable

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

Netherlands160 participantsStarted 2019-12-02

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study is measuring optic nerve sheath diameter using ultrasound after cardiac arrest — can you explain what that measurement tells doctors about brain swelling, and whether that kind of monitoring is already part of my loved one's current care?
2Since this trial has no listed phase and focuses on predicting outcomes using the Glasgow Coma Scale, does that mean it's primarily an observational study rather than one testing a new treatment, and how would that affect what participating actually involves day-to-day?
3The recruitment status for this trial is listed as unknown — do you know whether this study is still actively enrolling patients, and if not, are there similar studies looking at brain monitoring after cardiac arrest that might be available to us?
4Given that this trial is focused on post-anoxic coma after cardiac arrest, how does the Glasgow Coma Scale measurement being used here compare to other tools you're already using to assess neurological recovery, and would joining this study add any meaningful risk or burden on top of that?
5Are there standard care approaches for monitoring and predicting outcomes after cardiac arrest that we should be pursuing regardless of whether this trial is an option, so we can understand what this study would add beyond what's already available?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Glasgow Coma Scale

Timeframe: At 6 months after cardiac arrest

Trial details

NCT IDNCT04084054

SponsorRijnstate Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-12-31

Contact for this trial

Marlous Verhulst

+31 (0)88 005 7745 MMLHverhulst@rijnstate.nl

View on ClinicalTrials.gov More Post-Anoxic Coma trials