TY - JOUR
T1 - Intensive care unit randomised trial comparing two approaches to oxygen therapy (ICU-ROX)
T2 - results of the pilot phase
AU - Young, Paul J
AU - Mackle, Diane M
AU - Bailey, Michael J
AU - Beasley, Richard W
AU - Bennett, Victoria
AU - Deane, Adam M
AU - Eastwood, Glenn M
AU - Finfer, Simon
AU - Freebairn, Ross C
AU - Litton, Edward
AU - Linke, Natalie
AU - McArthur, Colin J
AU - McGuinness, Shay P
AU - Panwar, Rakshit
AU - Bellomo, Rinaldo
AU - The ICU-ROX pilot investigators
AU - Peck, Leah
AU - Young, Helen
AU - Closey, David
AU - Henderson, Seton
AU - Mehrtens, Jan
AU - Minto, Emmeline
AU - Morris, Anna
AU - Noble, Sascha
AU - Parker, Kim
AU - Palermo, Annamaria
AU - Pellicano, Susan
AU - Carpenter, Maude
AU - Hacking, Danielle
AU - Lawrey, Ywain
AU - Doherty, Sarah
AU - Glasby, Kathleen
AU - Poole, Alex
AU - Rivett, Justine
AU - Hunt, Anna
AU - Hurford, Sally
AU - Navarra, Leanlove
AU - Australian and New Zealand Intensive Care Society Clinical Trials Group
AU - Sol Cruz, Raulle
PY - 2017/12
Y1 - 2017/12
N2 - 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 [SpO2Z]). 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 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). 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).
AB - 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 [SpO2Z]). 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 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). 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).
UR - https://www.scopus.com/pages/publications/85039986240
M3 - Article
C2 - 29202261
AN - SCOPUS:85039986240
SN - 1441-2772
VL - 19
SP - 344
EP - 354
JO - Critical Care and Resuscitation
JF - Critical Care and Resuscitation
IS - 4
ER -