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

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          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.

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          Most cited references34

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          Determinants of long-term survival after major surgery and the adverse effect of postoperative complications.

          The objective of this study was to identify the determinants of 30-day postoperative mortality and long-term survival after major surgery as exemplified by 8 common operations. The National Surgical Quality Improvement Program (NSQIP) database contains pre-, intra-, and 30-day postoperative data, prospectively collected in a standardized fashion by a dedicated nurse reviewer, on major surgery in the Veterans Administration (VA). The Beneficiary Identification and Records Locator Subsystem (BIRLS) is a VA file that depicts the vital status of U.S. veterans with 87% to 95% accuracy. NSQIP data were merged with BIRLS to determine the vital status of 105,951 patients who underwent 8 types of operations performed between 1991 and 1999, providing an average follow up of 8 years. Logistic and Cox regression analyses were performed to identify the predictors of 30-day mortality and long-term survival, respectively. The most important determinant of decreased postoperative survival was the occurrence, within 30 days postoperatively, of any one of 22 types of complications collected in the NSQIP. Independent of preoperative patient risk, the occurrence of a 30-day complication in the total patient group reduced median patient survival by 69%. The adverse effect of a complication on patient survival was also influenced by the operation type and was sustained even when patients who did not survive for 30 days were excluded from the analyses. The occurrence of a 30-day postoperative complication is more important than preoperative patient risk and intraoperative factors in determining the survival after major surgery in the VA. Quality and process improvement in surgery should be directed toward the prevention of postoperative complications.
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            Association between driving pressure and development of postoperative pulmonary complications in patients undergoing mechanical ventilation for general anaesthesia: a meta-analysis of individual patient data.

            Protective mechanical ventilation strategies using low tidal volume or high levels of positive end-expiratory pressure (PEEP) improve outcomes for patients who have had surgery. The role of the driving pressure, which is the difference between the plateau pressure and the level of positive end-expiratory pressure is not known. We investigated the association of tidal volume, the level of PEEP, and driving pressure during intraoperative ventilation with the development of postoperative pulmonary complications.
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              High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial.

              The role of positive end-expiratory pressure in mechanical ventilation during general anaesthesia for surgery remains uncertain. Levels of pressure higher than 0 cm H2O might protect against postoperative pulmonary complications but could also cause intraoperative circulatory depression and lung injury from overdistension. We tested the hypothesis that a high level of positive end-expiratory pressure with recruitment manoeuvres protects against postoperative pulmonary complications in patients at risk of complications who are receiving mechanical ventilation with low tidal volumes during general anaesthesia for open abdominal surgery. In this randomised controlled trial at 30 centres in Europe and North and South America, we recruited 900 patients at risk for postoperative pulmonary complications who were planned for open abdominal surgery under general anaesthesia and ventilation at tidal volumes of 8 mL/kg. We randomly allocated patients to either a high level of positive end-expiratory pressure (12 cm H2O) with recruitment manoeuvres (higher PEEP group) or a low level of pressure (≤2 cm H2O) without recruitment manoeuvres (lower PEEP group). We used a centralised computer-generated randomisation system. Patients and outcome assessors were masked to the intervention. Primary endpoint was a composite of postoperative pulmonary complications by postoperative day 5. Analysis was by intention-to-treat. The study is registered at Controlled-Trials.com, number ISRCTN70332574. From February, 2011, to January, 2013, 447 patients were randomly allocated to the higher PEEP group and 453 to the lower PEEP group. Six patients were excluded from the analysis, four because they withdrew consent and two for violation of inclusion criteria. Median levels of positive end-expiratory pressure were 12 cm H2O (IQR 12-12) in the higher PEEP group and 2 cm H2O (0-2) in the lower PEEP group. Postoperative pulmonary complications were reported in 174 (40%) of 445 patients in the higher PEEP group versus 172 (39%) of 449 patients in the lower PEEP group (relative risk 1·01; 95% CI 0·86-1·20; p=0·86). Compared with patients in the lower PEEP group, those in the higher PEEP group developed intraoperative hypotension and needed more vasoactive drugs. A strategy with a high level of positive end-expiratory pressure and recruitment manoeuvres during open abdominal surgery does not protect against postoperative pulmonary complications. An intraoperative protective ventilation strategy should include a low tidal volume and low positive end-expiratory pressure, without recruitment manoeuvres. Academic Medical Center (Amsterdam, Netherlands), European Society of Anaesthesiology. Copyright © 2014 Elsevier Ltd. All rights reserved.
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                Author and article information

                Contributors
                Role: cardiorespiratory clinical lead physiotherapist
                Role: honorary research fellow
                Role: allied health clinical education lead
                Role: senior physiotherapy lecturer
                Role: senior acute care physiotherapist
                Role: senior cardiorespiratory physiotherapist
                Role: senior biostatistician
                Role: professor of anaesthesiology and head of unit
                Role: professor of physiotherapy, head of school, and professor of allied health research
                Journal
                BMJ
                BMJ
                BMJ-UK
                bmj
                The BMJ
                BMJ Publishing Group Ltd.
                0959-8138
                1756-1833
                2018
                24 January 2018
                : 360
                : j5916
                Affiliations
                [1 ]Department of Physiotherapy, Launceston General Hospital, Launceston, TAS, 7250, Australia
                [2 ]Department of Physiotherapy, The University of Melbourne, Melbourne, VIC, 3010, Australia
                [3 ]Directorate of Community Integration, Allied Health and Service Planning, Western Health, Melbourne, VIC, Australia
                [4 ]School of Clinical Sciences, Faculty of Health and Environmental Sciences, Auckland University of Technology, Auckland, New Zealand
                [5 ]Physiotherapy Department, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand
                [6 ]Physiotherapy Department, North West Regional Hospital, Burnie, TAS, Australia
                [7 ]Clifford Craig Foundation, Launceston General Hospital, Launceston, TAS, Australia
                [8 ]School of Health Sciences, University of Tasmania, Launceston, TAS, Australia
                [9 ]Anaesthesia Perioperative and Pain Medicine Unit, Melbourne Medical School, The University of Melbourne, Melbourne, VIC, Australia
                [10 ]Melbourne School of Health Sciences, The University of Melbourne, VIC, Australia
                [11 ]Peter MacCallum Cancer Centre, Melbourne, VIC, Australia
                Author notes
                Correspondence to: I Boden ianthe.boden@ 123456ths.tas.gov.au
                Article
                bodi041081
                10.1136/bmj.j5916
                5782401
                29367198
                6ba6022c-8046-43bc-924a-baa6a17a51c7
                Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions

                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/.

                History
                : 12 December 2017
                Categories
                Research

                Medicine
                Medicine

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