Details

Autor(en) / Beteiligte

• 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

Titel

Intensive care unit randomised trial comparing two approaches to oxygen therapy (ICU-ROX): Results of the pilot phase

Ist Teil von

• Critical care and resuscitation, 2017-12, Vol.19 (4), p.344-354

Ort / Verlag

Australia

Erscheinungsjahr

2017

Quelle

MEDLINE

Beschreibungen/Notizen

• Objective: The objective of the intensive care unit randomised trial comparing two approaches to oxygen therapy (ICU-ROX) pilot phase, which included the fi rst 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 confi rmed by study monitors to fulfi l the study eligibility criteria. 3.6 patients per site per month were enrolled (95% confi dence interval [CI], 2.5-4.7). Patients allocated to conservative oxygen therapy spent signifi cantly 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 fi ndings confi rm 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).