Key result
Liberal and restricted peri-operative oxygen therapy regimens successfully achieved distinct intra-operative FiO2 targets compared to standard care, meeting all feasibility endpoints.
Why the study?
International guidelines recommend liberal peri-operative oxygen during general anaesthesia, but the optimal regimen to minimise postoperative complications and enhance recovery remains uncertain.
Does restricted or liberal peri-operative oxygen therapy improve protocol implementation and safety in adults undergoing prolonged non-cardiac surgery compared to standard care?
RCT (n=210)
patient- and assessor-blinded
randomised
Yes
Does restricted or liberal peri-operative oxygen therapy improve protocol implementation and safety in adults undergoing prolonged non-cardiac surgery compared to standard care?
Mean Difference: 0.36 (95% CI 0.33–0.39)
Absolute Event Rate: 0.83% vs 0.47%
p-value: p=<0.001
The HOT-ROX vanguard trial demonstrates the feasibility of randomizing patients to restricted, standard, or liberal peri-operative oxygen therapy without major protocol modifications or safety concerns.
Randomization to restricted, standard, or liberal peri-operative oxygen is feasible in prolonged non-cardiac surgery; supports larger trials on clinical outcomes.
Summary International recommendations encourage liberal administration of oxygen to patients having surgery under general anaesthesia, ostensibly to reduce surgical site infection. However, the optimal oxygen regimen to minimise postoperative complications and enhance recovery from surgery remains uncertain. The hospital operating theatre randomised oxygen (HOT‐ROX) trial is a multicentre, patient‐ and assessor‐blinded, parallel‐group, randomised clinical trial designed to assess the effect of a restricted, standard care, or liberal peri‐operative oxygen therapy regimen on days alive and at home after surgery in adults undergoing prolonged non‐cardiac surgery under general anaesthesia. Here, we report the findings of the internal vanguard feasibility phase of the trial undertaken in four large metropolitan hospitals in Australia and New Zealand that included the first 210 patients of a planned overall 2640 trial sample, with eight pre‐specified endpoints evaluating protocol implementation and safety. We screened a total of 956 participants between 1 September 2019 and 26 January 2021, with data from 210 participants included in the analysis. Median (IQR [range]) time‐weighted average intra‐operative F i O 2 was 0.30 (0.26–0.35 [0.20–0.59]) and 0.47 (0.44–0.51 [0.37–0.68]) for restricted and standard care, respectively (mean difference (95%CI) 0.17 (0.14–0.20), p < 0.001). Median time‐weighted average intra‐operative F i O 2 was 0.83 (0.80–0.85 [0.70–0.91]) for liberal oxygen therapy (mean difference (95%CI) compared with standard care 0.36 (0.33–0.39), p < 0.001). All feasibility endpoints were met. There were no significant patient adverse events. These data support the feasibility of proceeding with the HOT‐ROX trial without major protocol modifications.
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Frei et al. (2023) conducted an RCT in prolonged non-cardiac surgery under general anaesthesia (n=210). Liberal or restricted peri-operative oxygen therapy vs. Standard care was evaluated on time-weighted average intra-operative FiO2 (liberal vs standard care) (MD 0.36, 95% CI 0.33-0.39, p=<0.001). Liberal and restricted peri-operative oxygen therapy regimens successfully achieved distinct intra-operative FiO2 targets compared to standard care, meeting all feasibility endpoints.
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