ow OxyGen Intervention for Cardiac Arrest injury Limitation (LOGICAL) trial

Not Applicable

Active, not recruiting

• Conditions: hypoxic ischaemic encephalopathy; cardiac arrest; Neurological - Other neurological disorders; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12621000518864
• Lead Sponsor: Medical Research Institute of New Zealand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-04
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 1840

Inclusion Criteria

1. Aged greater than or equal to 18 years AND
2. Receiving invasive mechanical ventilation in the ICU following a cardiac arrest AND
3. Suspected of having hypoxic ischaemic encephalopathy (i.e. the patient has not obeyed commands following resuscitation from a cardiac arrest and there is clinical concern about possible brain damage)

Exclusion Criteria

1. Enrolment is not considered in the patient’s best interests by the treating clinician (e.g. the patient is expected to die and is not being treated with curative intent or the treating clinician considers that one study treatment arm is either indicated or contraindicated) OR
2. Previously enrolled in the Mega-ROX trial OR
3. Greater than 12 hours have elapsed since the patient fulfilled the inclusion criteria

When a patient is not enrolled within 12 hours of fulfilling the eligibility criteria, he /she will be counted as eligible but missed” rather than excluded” for the purposes of describing participant flow.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is good neurological outcome measured with the Extended Glasgow Outcome Scale (GOS-E). A good neurological outcome will be defined as a GOS-E of lower moderate disability or better (i.e. GOS-E 5-8). The GOS-E is a widely used outcome measure in patients with hypoxic brain injury. It categorises patients into one of the following eight categories: death, vegetative state, lower severe disability, upper severe disability, lower moderate disability, upper moderate disability, lower good recovery, and upper good recovery. In ascertaining the GOS-E, which will be assessed by a blinded, trained outcome assessor, we will use a structured interview to ensure consistency in ratings. [ 180 days post randomisation]