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Research

Preoperative physiotherapy for the prevention of respiratory complications after upper abdominal surgery: pragmatic, double blinded, multicentre randomised controlled trial

BMJ 2018; 360 doi: https://doi.org/10.1136/bmj.j5916 (Published 24 January 2018) Cite this as: BMJ 2018;360:j5916

This article has a correction. Please see:

  1. Ianthe Boden, cardiorespiratory clinical lead physiotherapist1 2,
  2. Elizabeth H Skinner, honorary research fellow2 3,
  3. Laura Browning, allied health clinical education lead2 3,
  4. Julie Reeve, senior physiotherapy lecturer4 5,
  5. Lesley Anderson, senior acute care physiotherapist5,
  6. Cat Hill, senior cardiorespiratory physiotherapist6,
  7. Iain K Robertson, senior biostatistician7 8,
  8. David Story, professor of anaesthesiology and head of unit9,
  9. Linda Denehy, professor of physiotherapy, head of school, and professor of allied health research10 11
  1. 1Department of Physiotherapy, Launceston General Hospital, Launceston, TAS, 7250, Australia
  2. 2Department of Physiotherapy, The University of Melbourne, Melbourne, VIC, 3010, Australia
  3. 3Directorate of Community Integration, Allied Health and Service Planning, Western Health, Melbourne, VIC, Australia
  4. 4School of Clinical Sciences, Faculty of Health and Environmental Sciences, Auckland University of Technology, Auckland, New Zealand
  5. 5Physiotherapy Department, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand
  6. 6Physiotherapy Department, North West Regional Hospital, Burnie, TAS, Australia
  7. 7Clifford Craig Foundation, Launceston General Hospital, Launceston, TAS, Australia
  8. 8School of Health Sciences, University of Tasmania, Launceston, TAS, Australia
  9. 9Anaesthesia Perioperative and Pain Medicine Unit, Melbourne Medical School, The University of Melbourne, Melbourne, VIC, Australia
  10. 10Melbourne School of Health Sciences, The University of Melbourne, VIC, Australia
  11. 11Peter MacCallum Cancer Centre, Melbourne, VIC, Australia
  1. Correspondence to: I Boden ianthe.boden{at}ths.tas.gov.au
  • Accepted 12 December 2017

Abstract

Objective To assess the efficacy of a single preoperative physiotherapy session to reduce postoperative pulmonary complications (PPCs) after upper abdominal surgery.

Design Prospective, pragmatic, multicentre, patient and assessor blinded, parallel group, randomised placebo controlled superiority trial.

Setting Multidisciplinary preadmission clinics at three tertiary public hospitals in Australia and New Zealand.

Participants 441 adults aged 18 years or older who were within six weeks of elective major open upper abdominal surgery were randomly assigned through concealed allocation to receive either an information booklet (n=219; control) or preoperative physiotherapy (n=222; intervention) and followed for 12 months. 432 completed the trial.

Interventions Preoperatively, participants received an information booklet (control) or an additional 30 minute physiotherapy education and breathing exercise training session (intervention). Education focused on PPCs and their prevention through early ambulation and self directed breathing exercises to be initiated immediately on regaining consciousness after surgery. Postoperatively, all participants received standardised early ambulation, and no additional respiratory physiotherapy was provided.

Main outcome measures The primary outcome was a PPC within 14 postoperative hospital days assessed daily using the Melbourne group score. Secondary outcomes were hospital acquired pneumonia, length of hospital stay, utilisation of intensive care unit services, and hospital costs. Patient reported health related quality of life, physical function, and post-discharge complications were measured at six weeks, and all cause mortality was measured to 12 months.

Results The incidence of PPCs within 14 postoperative hospital days, including hospital acquired pneumonia, was halved (adjusted hazard ratio 0.48, 95% confidence interval 0.30 to 0.75, P=0.001) in the intervention group compared with the control group, with an absolute risk reduction of 15% (95% confidence interval 7% to 22%) and a number needed to treat of 7 (95% confidence interval 5 to 14). No significant differences in other secondary outcomes were detected.

Conclusion In a general population of patients listed for elective upper abdominal surgery, a 30 minute preoperative physiotherapy session provided within existing hospital multidisciplinary preadmission clinics halves the incidence of PPCs and specifically hospital acquired pneumonia. Further research is required to investigate benefits to mortality and length of stay.

Trial registration Australian New Zealand Clinical Trials Registry ANZCTR 12613000664741.

Footnotes

  • Contributors: IB conceived and designed the study, coordinated the trial, prepared the first draft of the manuscript, and was responsible for the final manuscript. IB, LB, EHS, JR, and LD developed the protocol. IB, JR, CH, and LA recruited the patients and acquired the data, and were responsible for protocol adherence and managing the trial at each of the sites. IB and IKR did the statistical analysis. IB, EHS, LB, JR, IKR, DS, and LD analysed and interpreted the data. All authors revised manuscript drafts, approved the final manuscript, and contributed intellectually important content. IB 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 study was an investigator initiated trial funded by competitive research grants from the Clifford Craig Foundation, Launceston, Australia, the University of Tasmania (virtual Tasmanian Academic Health Science Precinct), Tasmania, Australia, and the Awhina Contestable Research Grant from the Waitemata District Health Board and Three Harbours Health Foundation, Auckland, New Zealand, Support was provided from departmental sources at each participating study centre (Launceston General Hospital, North West Regional Hospital, North Shore Hospital) and through sponsorship by the Tasmanian Health Service-North to support IB for the period of the trial. The funding sources had no controlling role in the study design, data collection, analysis, interpretation, or report writing. All authors had full access to the data on trial completion and had final responsibility for publication submission.

  • Competing interests All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare that IB received grants from the Clifford Craig Foundation (CCF), University of Tasmania, and Waitemata District Health Board to fund participating sites for physiotherapists to provide preoperative interventions outside of current standard care and for research assistants to acquire data. JR, LA, and CH were also supported by these grants to coordinate the project at their respective sites. IKR receives a salary from the CCF to perform statistical analysis and provide study design advice for studies receiving grants from the CCF. IKR also receives information technology and library services from the University of Tasmania. Neither CCF nor the University of Tasmania have managerial authority over IKR’s work.

  • Ethical approval: This study was approved by the Human Research Ethics Committee (Tasmania) Network, Tasmania, Australia (H0011911) and the Health and Disability Ethics Committee, New Zealand (14/NTA/233) and informed written consent was given by all patients.

  • Data sharing: As prespecified a priori in the LIPPSMAck POP published protocol we welcome independent statistical analysis of our findings and provide open access to our anonymised primary dataset as an appendix. Participants gave informed consent for data sharing with organisations that submit a proposal for post hoc data analysis to the LIPPSMAck POP investigators and receive ethical clearance from their host institution and an approved amendment to the original ethics approvals provided by the two source ethics committees. Following this and on request (ianthe.boden@ths.tas.gov.au), the investigators will share the extended anonymised dataset (with associated coding library). Any published peer reviewed manuscripts derived from post hoc analysis of these shared data must list the LIPPSMAck POP investigators as coauthors.

  • Transparency: The lead author (IB) affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.

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 and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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