Intensive care unit randomised trial comparing two approaches to oxygen therapy (UK-ROX)

Not Applicable

• Conditions: Invasive ventilation in intensive care; Not Applicable

• Registration Number: ISRCTN13384956
• Lead Sponsor: Intensive Care National Audit & Research Centre (ICNARC)

Brief Summary

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38737312/ (added 08/07/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-08
• Last Update Posted: 22 July 2024
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 16500

Inclusion Criteria

1. Aged =18 years
2. Receiving invasive mechanical ventilation in the ICU following an unplanned ICU admission (i.e. not admitted after an elective procedure) OR invasive mechanical ventilation started in the ICU (i.e. the patient was intubated in the ICU)
3. Receiving supplemental oxygen (fractional inspired concentration of oxygen (FiO2) >0.21) at the time of enrolment

Exclusion Criteria

1. Previously randomised into UK-ROX in the last 90 days
2. The clinician considers that one study treatment arm is either indicated or contraindicated.

Removed 20/04/2021:
A data dictionary will contain relevant examples of conditions where clinicians may exclude patients (at their discretion) because conservative oxygen therapy is either indicated or contraindicated (e.g. chronic lung diseases, receiving hyperbaric oxygen, prior bleomycin exposure, carbon monoxide poisoning).

Added 22/02/2021:
3. Currently receiving extracorporeal membrane oxygenation (ECMO)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary clinical outcome:<br>90-day all-cause mortality, assessed through review of patient medical notes at 90 days post-randomisation and/or data linkage with nationally held death registrations<br><br>Primary economic outcome: <br>Incremental costs, QALYs and net monetary benefit at 90 days, assessed by combining Health-related Quality of Life (EuroQol EQ-5D-5L questionnaire) data with valued resource use data obtained via a health services questionnaire and data obtained through linkage with national hospital episode statistics, death registrations and the national clinical audit for adult critical care.