- Title
- Intensive care unit randomised trial comparing two approaches to oxygen therapy (ICU-ROX): results of the pilot phase
- Creator
- Young, Paul J.; Mackie, Diane M.; Linke, Natalie J.; McArthur, Colin J.; McGuinness, Shay P.; Panwar, Rakshit; Bellomo, Rinaldo; Bailey, Michael J.; Beasley, Richard W.; Bennett, Victoria L.; Deane, Adam M.; Eastwood, Glenn M.; Finfer, Simon; Freebairn, Ross C.; Litton, Edward
- Relation
- Critical Care and Resuscitation Vol. 19, Issue 4, p. 344-354
- Publisher
- Australasian Medical Publishing
- Resource Type
- journal article
- Date
- 2017
- Description
- Objective: The objective of the intensive care unit randomised trial comparing two approaches to oxygen therapy (ICU-ROX) pilot phase, which included the first 100 patients of an overall sample of 1000, was to examine feasibility. Design: Investigator-initiated, prospective, parallel-group, pilot randomised controlled trial. Setting: Six medical-surgical intensive care units (ICUs) in Australia and New Zealand, with participants recruited from September 2015 through June 2016. Participants: 100 patients ≥ 18 years of age who required invasive mechanical ventilation in the ICU and were expected to be receiving it beyond the next calendar day at the time of randomisation. Interventions: Conservative oxygen therapy or standard care. Main Outcome Measures: Eligibility, recruitment rate, and separation in oxygen exposure (fraction of inspired oxygen [FiO₂] and oxygen saturation measured by pulse oximetry [SpO₂]). Results: 94 of 99 participants (94.9%) were confirmed by study monitors to fulfil the study eligibility criteria. 3.6 patients per site per month were enrolled (95% confidence interval [CI], 2.5-4.7). Patients allocated to conservative oxygen therapy spent significantly more time on an FiO₂ of 0.21 in the ICU; median, 31.5 hours (interquartile range [IQR], 7-63.5) for conservative oxygen therapy patients v 0 hours for standard oxygen therapy patients (IQR, 0-10; midpoint difference, 21.5 hours; 95% CI, 9-34; P < 0.0001). Patients allocated to conservative oxygen therapy spent less time in the ICU with an SpO₂ of ≥ 97% than patients allocated to standard oxygen therapy; median, 18.5 hours (IQR, 5-46) for conservative oxygen therapy patients v 32 hours for standard oxygen therapy (IQR, 17-80; midpoint difference, 13.5 hours; 95% CI, 2-25; P = 0.02). Conclusions: Our findings confirm the feasibility of completing the ICU-ROX trial without the need for substantive changes to the study protocol for the remaining 900 trial participants. Trial Registration: Australian and New Zealand Clinical Trials Registry (ANZCTRN 12615000957594).
- Subject
- oxygen therapy; intensive care; randomised controlled trial
- Identifier
- http://hdl.handle.net/1959.13/1388110
- Identifier
- uon:32716
- Identifier
- ISSN:1441-2772
- Language
- eng
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