Respiratory failure & ventilation
A vanguard randomised feasibility trial comparing three regimens of peri‐operative oxygen therapy on recovery after major surgery
Authors' conclusion
These data support the feasibility of proceeding with the HOT-ROX trial without major protocol modifications.
Study context
- Population
- Adults undergoing prolonged non-cardiac surgery under GA, 4 metropolitan hospitals in Australia and New Zealand956 screened
- Participants
- 210 adults
- Comparison
- Restricted vs standard care vs liberal peri-operative oxygen therapy
- Primary endpoint
- 8 pre-specified feasibility endpoints evaluating protocol implementation and safety
Methodological detailsinternal vanguard feasibility phase, multicentre, patient- and assessor-blinded, parallel-group
- Internal vanguard feasibility phase
- Multicentre
- Patient- and assessor-blinded
- Parallel-group
Primary result
As reported in the abstract
Time-weighted average intra-operative FiO2
Restricted
0.30
median · IQR [range] 0.26-0.35 [0.20-0.59]
Standard care
0.47
median · IQR [range] 0.44-0.51 [0.37-0.68]
Liberal
0.83
median · IQR [range] 0.80-0.85 [0.70-0.91]
Mean difference (95% CI)P value
Standard care vs Restricted
0.17(0.14–0.20)
P < 0.001Liberal vs Standard care
0.36(0.33–0.39)
P < 0.001Safety
- No significant patient adverse events
Original publication
A vanguard randomised feasibility trial comparing three regimens of peri‐operative oxygen therapy on recovery after major surgery. Anaesthesia. Published 2 August 2023. doi:10. 1111/ anae. 16103
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