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|Title:||Intensive care unit randomised trial comparing two approaches to oxygen therapy (ICU-ROX): results of the pilot phase.|
|Authors:||Young, Paul J;Mackle, Diane M;Bailey, Michael J;Beasley, Richard W;Bennett, Victoria L;Deane, Adam M;Eastwood, Glenn M;Finfer, Simon;Freebairn, Ross C;Litton, Edward;Linke, Natalie J;McArthur, Colin J;McGuinness, Shay P;Panwar, Rakshit;Bellomo, Rinaldo|
|Affiliation:||Intensive Care Unit, Wellington Regional Hospital, Wellington, New Zealand|
Medical Research Institute of New Zealand, Wellington, New Zealand
Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia
Intensive Care Unit, Royal Melbourne Hospital, Melbourne, Australia
Intensive Care Unit, Austin Health, Heidelberg, Victoria, Australia
Intensive Care Unit, Royal North Shore Hospital, St Leonards, New South Wales, Australia
Intensive Care Unit, Fiona Stanley Hospital, Perth, Western Australia..
Intensive Care Unit, John Hunter Hospital, Newcastle, New South Wales, Australia
|Citation:||Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine 2017; 19(4): 344-354|
|Abstract:||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. Investigator-initiated, prospective, parallel-group, pilot randomised controlled trial. Six medical-surgical intensive care units (ICUs) in Australia and New Zealand, with participants recruited from September 2015 through June 2016. 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. Conservative oxygen therapy or standard care. Eligibility, recruitment rate, and separation in oxygen exposure (fraction of inspired oxygen [FiO2] and oxygen saturation measured by pulse oximetry [SpO2Z]). 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 FiO2of 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 SpO2Z 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). 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. Australian and New Zealand Clinical Trials Registry (ANZCTRN 12615000957594).|
Randomized Controlled Trial
|Appears in Collections:||Journal articles|
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