Non-invasive positive airway pressure thErapy to reduce postoperative lung complications following upper abdominal surgery (NIPPER PLUS): a pilot randomised control trial
Objectives:Postoperative pulmonary complications (PPC) are a common serious complication following upper abdominal surgery. Postoperatively, physiotherapy-led non-invasive ventilation (NIV) may be a promising method to reduce PPC incidence. The objectives of this pilot trial were to examine preliminary effectiveness, feasibility and safety of additional intermittent physiotherapy-led NIV compared to continuous high-flow nasal cannula oxygen therapy (HFNC) alone.
Design:Single-centre, assessor-blinded, parallel-group, pilot randomised control trial.
Setting:Primary-referral hospital in Australia.
Participants:130 high-risk patients undergoing upper abdominal surgery.
Interventions:Continuous HFNC for 48-hours following surgical extubation, or HFNC plus five 30-minute physiotherapy-led NIV sessions.
OutcomesPPC incidence, trial feasibility and safety.
Results:PPC incidence was similar between groups (HFNC alone 12/65 (18%) vs HFNC plus NIV 10/64 (16%) adjusted HR 0.95; 95% CI 0.40-2.29). Delivery of HFNC as per-protocol was achieved in 81% (n=105) of all participants. Physiotherapy-led NIV initiated within four-hours of surgical extubation was achieved in 81% (n=52) of intervention group participants, with a mean 4.2 (SD 1.3) total number of NIV sessions delivered in the first two postoperative days. NIV was delivered as per-protocol in 52% of this cohort. Two episodes of severe hypotension during NIV requiring medical intervention were reported.
Conclusion:Delivery of continuous HFNC was feasible. Delivery of NIV within four-hours of extubation was achieved and delivered safely with <1% adverse events. The planned NIV intervention of five sessions within two postoperative days was not feasible. The results of this pilot study have informed the decision not to proceed to a fully powered trial.
Department/SchoolSchool of Health Sciences
Place of publicationUnited Kingdom
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