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| Non-invasive positive airway pressure therapy to reduce postoperative lung complications following upper abdominal surgery (NIPPER PLUS): a pilot randomised control trial [with consumer summary] |
| Lockstone J, Parry SM, Denehy L, Robertson IK, Story D, Boden I |
| Physiotherapy 2022 Dec;117:25-34 |
| clinical trial |
| 7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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OBJECTIVES: Postoperative pulmonary complications (PPCs) 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. OUTCOMES: PPC incidence, trial feasibility and safety. RESULTS: PPC incidence was similar between groups (HFNC alone 12/65 (18%) versus HFNC plus NIV 10/64 (16%) adjusted HR 0.95; 95% CI 0.40 to 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. CLINICAL TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, www.anzctr.org.au ACTRN12617000269336.
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