非侵入性正压通气治疗减少上腹部手术后肺部并发症（NIPPER PLUS）：一项先导随机对照试验。

Non-Invasive Positive airway Pressure thErapy to Reduce Postoperative Lung complications following Upper abdominal Surgery (NIPPER PLUS): a pilot randomised control trial.

机构信息

Department of Physiotherapy, Launceston General Hospital, Launceston, TAS 7250, Australia; Department of Physiotherapy, The University of Melbourne, Melbourne, VIC 3052, Australia.

Department of Physiotherapy, The University of Melbourne, Melbourne, VIC 3052, Australia.

出版信息

Physiotherapy. 2022 Dec;117:25-34. doi: 10.1016/j.physio.2022.06.001. Epub 2022 Jun 13.

DOI:10.1016/j.physio.2022.06.001

PMID:36242928

Abstract

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%) 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.

CLINICAL TRIAL REGISTRATION

Australian New Zealand Clinical Trials Registry, www.anzctr.org.au ACTRN12617000269336. CONTRIBUTION OF THE PAPER.

摘要

目的

术后肺部并发症（PPCs）是上腹部手术后常见的严重并发症。术后，以物理治疗为基础的无创通气（NIV）可能是降低 PPC 发生率的一种有前途的方法。本试验的目的是检验与单独持续高流量鼻导管吸氧（HFNC）相比，附加间歇性以物理治疗为基础的 NIV 的初步有效性、可行性和安全性。

设计

单中心、评估者盲法、平行组、试验性随机对照试验。

地点

澳大利亚的一家初级转诊医院。

参与者

130 名高危上腹部手术患者。

干预措施

术后拔管后 48 小时内持续使用 HFNC，或 HFNC 加 5 次 30 分钟以物理治疗为基础的 NIV 治疗。

结果

两组之间的 PPC 发生率相似（HFNC 组 12/65（18%），HFNC 加 NIV 组 10/64（16%），调整后的 HR 0.95；95%CI 0.40-2.29）。所有参与者中，HFNC 按方案使用的比例为 81%（n=105）。干预组中有 81%（n=52）的患者在术后 4 小时内开始进行以物理治疗为基础的 NIV，在前 2 天的术后期间共进行了 4.2（SD 1.3）次 NIV 治疗。在这一组中，有 52%的患者按方案进行了 NIV 治疗。报告了两例需要医疗干预的严重低血压发作。