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Surgery
Protocol
Non-Invasive Positive airway Pressure thErapy to Reduce Postoperative Lung complications following Upper abdominal Surgery (NIPPER PLUS): protocol for a single-centre, pilot, randomised controlled trial
  1. Jane Lockstone1,2,
  2. Ianthe Boden1,2,
  3. Iain K Robertson3,
  4. David Story4,
  5. Linda Denehy2,
  6. Selina M Parry2
  1. 1 Department of Physiotherapy, Launceston General Hospital, Launceston, Tasmania, Australia
  2. 2 Department of Physiotherapy, The University of Melbourne, Melbourne, Victoria, Australia
  3. 3 School of Health Sciences, University of Tasmania, Launceston, Tasmania, Australia
  4. 4 Anaesthesia Perioperative and Pain Medicine Unit, Melbourne Medical School, The University of Melbourne, Melbourne, Victoria, Australia
  1. Correspondence to Jane Lockstone; jane.lockstone{at}ths.tas.gov.au

Abstract

Introduction Postoperative pulmonary complications (PPCs) are a common serious complication following upper abdominal surgery leading to significant consequences including increased mortality, hospital costs and prolonged hospitalisation. The primary objective of this study is to detect whether there is a possible signal towards PPC reduction with the use of additional intermittent non-invasive ventilation (NIV) compared with continuous high-flow nasal oxygen therapy alone following high-risk elective upper abdominal surgery. Secondary objectives are to measure feasibility of: (1) trial conduct and design and (2) physiotherapy-led NIV and a high-flow nasal oxygen therapy protocol, safety of NIV and to provide preliminary costs of care information of NIV and high-flow nasal oxygen therapy.

Methods and analysis This is a single-centre, parallel group, assessor blinded, pilot, randomised trial, with 130 high-risk upper abdominal surgery patients randomly assigned via concealed allocation to either (1) usual care of continuous high-flow nasal oxygen therapy for 48 hours following extubation or (2) usual care plus five additional 30 min physiotherapy-led NIV sessions within the first two postoperative days. Both groups receive standardised preoperative physiotherapy and postoperative early ambulation. No additional respiratory physiotherapy is provided to either group. Outcome measures will assess incidence of PPC within the first 14 postoperative days, recruitment ability, physiotherapy-led NIV and high-flow nasal oxygen therapy protocol adherence, adverse events relating to NIV delivery and costs of providing a physiotherapy-led NIV and a high-flow nasal oxygen therapy service following upper abdominal surgery.

Ethics and dissemination Ethics approval has been obtained from the relevant institution and results will be published to inform future multicentre trials.

Trial registration number ACTRN12617000269336; Pre-results.

  • adult surgery
  • adult anaesthesia

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2018-023139

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    Footnotes

    • Patient consent for publication Not required.

    • Contributors IB and JL conceived and designed the study and coordinated the trial. LD and SMP assisted in final study design and protocol. JL prepared the first draft of the protocol manuscript and was responsible for the final manuscript. All authors revised all manuscript drafts, approved the final manuscript and contributed intellectually important content. JL is the guarantor of the paper and takes responsibility for the integrity of the work as a whole, from inception to published article.

    • Funding This work was supported by the Clifford Craig Foundation, Launceston, Australia (Project 160).

    • Disclaimer The funding body has no influence on the study design, collection or data analysis or publication of results.

    • Competing interests None declared.

    • Ethics approval The trial is being conducted in accordance with the Declaration of Helsinki and has undergone ethics review by the Tasmanian Health Human Research Ethics Committee and received approval 08/02/2017 (protocol reference H0016207). All participants will provide written informed consent.

    • Provenance and peer review Not commissioned; externally peer reviewed.