Comparison of 6-Month Outcomes of Survivors of COVID-19 versus Non-COVID-19 Critical Illness.

Rationale: The outcomes of survivors of critical illness due to coronavirus disease (COVID-19) compared with non-COVID-19 are yet to be established. Objectives: We aimed to investigate new disability at 6 months in mechanically ventilated patients admitted to Australian ICUs with COVID-19 compared with non-COVID-19. Methods: We included critically ill patients with COVID-19 and non-COVID-19 from two prospective observational studies. Patients were eligible if they were adult (age ⩾ 8 yr) and received ⩾24 hours of mechanical ventilation. In addition, patients with COVID-19 were eligible with a positive laboratory PCR test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Measurements and Main Results: Demographic, intervention, and hospital outcome data were obtained from electronic medical records. Survivors were contacted by telephone for functional outcomes with trained outcome assessors using the World Health Organization Disability Assessment Schedule 2.0. Between March 6, 2020, and April 21, 2021, 120 critically ill patients with COVID-19, and between August 2017 and January 2019, 199 critically ill patients without COVID-19, fulfilled the inclusion criteria. Patients with COVID-19 were older (median [interquartile range], 62 [55-71] vs. 58 [44-69] yr; P = 0.019) with a lower Acute Physiology and Chronic Health Evaluation II score (17 [13-20] vs. 19 [15-23]; P = 0.011). Although duration of ventilation was longer in patients with COVID-19 than in those without COVID-19 (12 [5-19] vs. 4.8 [2.3-8.8] d; P < 0.001), 180-day mortality was similar between the groups (39/120 [32.5%] vs. 70/199 [35.2%]; P = 0.715). The incidence of death or new disability at 180 days was similar (58/93 [62.4%] vs. 99/150 [66/0%]; P = 0.583). Conclusions: At 6 months, there was no difference in new disability for patients requiring mechanical ventilation for acute respiratory failure due to COVID-19 compared with non-COVID-19. Clinical trial registered with www.clinicaltrials.gov (NCT04401254).

Prophylactic Postoperative Noninvasive Ventilation in Adults Undergoing Upper Abdominal Surgery: A Systematic Review and Meta-Analysis.

OBJECTIVES: Postoperative pulmonary complications (PPCs) are a leading cause of morbidity and mortality following upper abdominal surgery. Applying either noninvasive ventilation (NIV) or continuous positive airway pressure (CPAP) in the early postoperative period is suggested to prevent PPC. We aimed to assess whether postoperative NIV or CPAP or both prevent PPCs compared with standard care in adults undergoing upper abdominal surgery, including in those identified at higher PPC risk. Additionally, the different interventions used were evaluated to assess whether there is a superior approach. DATA SOURCES: We searched PubMed, Embase' CINAHL, CENTRAL, and Scopus from inception to May 17, 2021. STUDY SELECTION: We performed a systematic search of the literature for randomized controlled trials evaluating prophylactic NIV and/or CPAP in the postoperative period. DATA EXTRACTION: Two authors independently performed study selection and data extraction. Individual study risk of bias was assessed using the PEDro scale, and certainty in outcomes was assessed using the Grading of Recommendations Assessment, Development, and Evaluation framework. DATA SYNTHESIS: We included 17 studies enrolling 6,108 patients. No significant benefit was demonstrated for postoperative NIV/CPAP to reduce PPC (risk ratio [RR], 0.89; 95% CI, 0.78-1.01; very low certainty), including in adults identified at higher PPC risk (RR, 0.91; 95% CI, 0.77-1.07; very low certainty). No intervention approach was identified as superior, and no significant benefit was demonstrated when comparing: 1) CPAP (RR, 0.90; 95% CI, 0.79-1.04; very low certainty), 2) NIV (RR, 0.68; 95% CI, 0.41-1.13; very low certainty), 3) continuous NIV/CPAP (RR, 0.90; 95% CI, 0.77-1.05; very low certainty), or 4) intermittent NIV/CPAP (RR, 0.66; 95% CI, 0.39-1.10; very low certainty) to standard care. CONCLUSIONS: These findings suggest routine provision of either prophylactic NIV or CPAP following upper abdominal surgery may not be effective to reduce PPCs' including in those identified at higher risk.

Inspiratory muscle training in intensive care unit patients: An international cross-sectional survey of physiotherapist practice.

BACKGROUND: Inspiratory muscle training is safe and effective in reversing inspiratory muscle weakness and improving outcomes in patients who have experienced prolonged mechanical ventilation in the intensive care unit (ICU). The degree of worldwide implementation of inspiratory muscle training in such patients has not been investigated. OBJECTIVES: The objectives of this study were to describe the current practice of inspiratory muscle training by intensive care physiotherapists and investigate barriers to implementation in the intensive care context and additionally to determine if any factors are associated with the use of inspiratory muscle training in patients in the ICU and identify preferred methods of future education. METHOD: Online cross-sectional surveys of intensive care physiotherapists were conducted using voluntary sampling. Multivariate logistic regression analysis was used to identify factors associated with inspiratory muscle training use in patients in the ICU. RESULTS: Of 360 participants, 63% (95% confidence interval [CI] = 58 to 68) reported using inspiratory muscle training in patients in the ICU, with 69% (95% CI = 63 to 75) using a threshold device. Only 64% (95% CI = 58 to 70) of participants who used inspiratory muscle training routinely assessed inspiratory muscle strength. The most common barriers to implementing inspiratory muscle training sessions in eligible patients were sedation and delirium. Participants were 4.8 times more likely to use inspiratory muscle training in patients if they did not consider equipment a barrier and were 4.1 times more likely to use inspiratory muscle training if they aware of the evidence for this training in these patients. For education about inspiratory muscle training, 41% of participants preferred online training modules. CONCLUSION: In this first study to describe international practice by intensive care therapists, 63% reported using inspiratory muscle training. Improving access to equipment and enhancing knowledge of inspiratory muscle training techniques could improve the translation of evidence into practice.

The impact of COVID-19 critical illness on new disability, functional outcomes and return to work at 6 months: a prospective cohort study.

BACKGROUND: There are few reports of new functional impairment following critical illness from COVID-19. We aimed to describe the incidence of death or new disability, functional impairment and changes in health-related quality of life of patients after COVID-19 critical illness at 6 months. METHODS: In a nationally representative, multicenter, prospective cohort study of COVID-19 critical illness, we determined the prevalence of death or new disability at 6 months, the primary outcome. We measured mortality, new disability and return to work with changes in the World Health Organization Disability Assessment Schedule 2.0 12L (WHODAS) and health status with the EQ5D-5LTM. RESULTS: Of 274 eligible patients, 212 were enrolled from 30 hospitals. The median age was 61 (51-70) years, and 124 (58.5%) patients were male. At 6 months, 43/160 (26.9%) patients died and 42/108 (38.9%) responding survivors reported new disability. Compared to pre-illness, the WHODAS percentage score worsened (mean difference (MD), 10.40% [95% CI 7.06-13.77]; p < 0.001). Thirteen (11.4%) survivors had not returned to work due to poor health. There was a decrease in the EQ-5D-5LTM utility score (MD, - 0.19 [- 0.28 to - 0.10]; p < 0.001). At 6 months, 82 of 115 (71.3%) patients reported persistent symptoms. The independent predictors of death or new disability were higher severity of illness and increased frailty. CONCLUSIONS: At six months after COVID-19 critical illness, death and new disability was substantial. Over a third of survivors had new disability, which was widespread across all areas of functioning. Clinical trial registration NCT04401254 May 26, 2020.

Validity and Utility Testing of a Criteria-led Discharge Checklist to Determine Post-operative Recovery after Abdominal Surgery: an International Multicentre Prospective Cohort Trial.

BACKGROUND: Criteria-led discharge (CLD) has promising potential to reduce unnecessary hospital stay after abdominal surgery; however, the validity and utility of CLD is uncertain as studies are limited to small single-centre studies involving predominantly elective colorectal surgery. METHODS: This prospective international multicentre cohort study explored the relationship between a CLD checklist, post-operative recovery, and hospital length of stay using patient-level data from four clinical trials involving 1071 adults undergoing all types of emergency and elective abdominal surgery at five hospitals across Australia and New Zealand. Patients were assessed daily for 21 post-operative days using a standardised CLD checklist. Surgeons and hospital clinicians were masked to findings. Criterion, construct, and content validity of the checklist to accurately reflect discharge decisions by surgical teams, assess physiological recovery, and encompass parameters signalling physiological readiness to discharge were tested. Potential utility of CLD to minimise unnecessary hospital stay was assessed by comparing day of readiness to discharge to actual day of discharge. RESULTS: The CLD checklist had concordance with existing discharge planning practices and accurately measured a longer post-operative recovery in more complex clinical situations. The CLD checklist in its current format did not detect all legitimate medical and surgical reasons necessitating a continued stay in hospital. Day of readiness to discharge was 0.8 days (95% CI 0.7 to 0.9, p < 0.001) less than actual day of discharge. CONCLUSION: A CLD checklist has excellent criterion and construct validity in measuring physiological recovery following all types of major elective and emergency abdominal surgery. Content validity could be improved. The use of CLD has the potential to reduce unnecessary hospital stay although the safety of discharging patients according to the criteria requires investigation prior to implementation. TRIAL REGISTRATION: Trials were prospectively registered at the Australian New Zealand Clinical Trials Registry (LIPPSMAck POP 12613000664741, ICEAGE 12615000318583, PLASTIC 12619001344189, NIPPER PLUS 12617000269336).

Preoperative physiotherapy prevents postoperative pulmonary complications after major abdominal surgery: a meta-analysis of individual patient data.

QUESTIONS: Among patients having elective abdominal surgery, how much does preoperative physiotherapy education with breathing exercise training reduce the incidence of postoperative pulmonary complications (PPCs), hospital length of stay and 12-month mortality? How stable are the treatment effects across different PPC definitions, including pneumonia? How much do the treatment effects on PPC, hospital length of stay and mortality vary within clinically relevant subgroups? DESIGN: Individual participant-level meta-analysis (n = 800) from two randomised controlled trials analysed with multivariable regression. PARTICIPANTS: Adults undergoing major elective abdominal surgery. INTERVENTIONS: Experimental participants received a single preoperative session with a physiotherapist within 4 weeks of surgery and educated on PPC prevention with breathing exercises and early mobilisation. They were taught breathing exercises and instructed to start them immediately on waking from surgery. The control group received no preoperative or postoperative physiotherapy, or early ambulation alone. OUTCOME MEASURES: PPC, hospital length of stay and 12-month mortality. RESULTS: Participants who received preoperative physiotherapy had 47% lower odds of developing a PPC (adjusted OR 0.53, 95% CI 0.34 to 0.85). This effect was stable regardless of PPC definition. Effects were greatest in participants who smoked, were aged ≤ 45 years, had abnormal body weight, had multiple comorbidities, or were undergoing bariatric or upper gastrointestinal surgery. Participants having operations ≤ 3 hours in duration were least responsive to preoperative physiotherapy. Participants with multiple comorbidities were more likely to have a shorter hospital stay if provided with preoperative physiotherapy (adjusted MD -3.2 days, 95% CI -6.2 to -0.3). Effects on mortality were uncertain. CONCLUSION: There is strong evidence to support preoperative physiotherapy in preventing PPCs after elective abdominal surgery.

PHYSIO+++: protocol for a pilot randomised controlled trial assessing the feasibility of physiotherapist-led non-invasive ventilation for patients with hypoxaemia following abdominal surgery.

INTRODUCTION: Few clinical trials have investigated physiotherapy interventions to treat hypoxaemia following abdominal surgery. The objective of this study is to determine the feasibility and safety of conducting a clinical trial of physiotherapist-led non-invasive ventilation (NIV). METHODS AND ANALYSIS: This single-centre, 50-patient, parallel-group, assessor blinded, pilot feasibility randomised controlled trial with concealed allocation will enrol spontaneously ventilating adults with hypoxaemia within 72 hours of major abdominal surgery. Participants will receive either (1) usual care physiotherapy of a single education session (talk), daily walking of 10-15 min (walk) and four sessions of coached deep breathing and coughing (breathe) or (2) usual care physiotherapy plus four 30 min sessions of physiotherapist-led NIV delivered over 2 postoperative days. Primary feasibility and safety outcome measures are; number of eligible patients recruited per week, total time of NIV treatment delivered, acceptability of treatments to patients and clinicians and incidence of adverse events. Secondary feasibility outcomes include measures of recruitment and treatment adherence. Exploratory outcome measures include change in respiratory parameters, postoperative pulmonary complications, length of hospital stay, health-related quality of life, postoperative activity levels and mortality. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the relevant institution. Results will be published to inform future research. TRIAL REGISTRATION NUMBER: ACTRN12622000839707.

Intensive physical therapy after emergency laparotomy: Pilot phase of the Incidence of Complications following Emergency Abdominal surgery Get Exercising randomized controlled trial.

BACKGROUND: Postoperative pneumonia and delayed physical recovery are significant problems after emergency laparotomy. No randomized controlled trial has assessed the feasibility, safety, or effectiveness of intensive postoperative physical therapy in this high-risk acute population. METHODS: The internal pilot phase of the Incidence of Complications after Emergency Abdominal Surgery: Get Exercising (ICEAGE) trial was a prospective, randomized controlled trial that evaluated the feasibility, safety, and clinical trial processes of providing intensive physical therapy immediately following emergency laparotomy. Fifty consecutive patients were recruited at the principal participating hospital and randomly assigned to standard-care or intensive physical therapy of twice daily coached breathing exercises for 2 days and 30 minutes of daily supervised rehabilitation over the first 5 postoperative days. RESULTS: Interventions were provided exactly as per protocol in 35% (78 of 221 patients) of planned treatment sessions. Main barriers to protocol delivery were physical therapist unavailability on weekends (59 of 221 patients [27%]), awaiting patient consent (18 of 99 patients [18%]), and patient fatigue (26 of 221 patients [12%]). Despite inhibitors to treatment delivery, the intervention group still received twice as many breathing exercise sessions and four times the amount of physical therapy over the first 5 postoperative days (23 minutes [interquartile range, 12-29 minutes] vs. 86 minutes [interquartile range, 53-121 minutes]; p < 0.001). One adverse event was reported from 78 rehabilitation sessions (1.3%), which resolved fully on cessation of activity without escalation of medical care. CONCLUSION: Intensive postoperative physical therapy can be delivered safely and successfully to patients in the first week after emergency laparotomy. The ICEAGE trial protocol resulted in intervention group participants receiving more coached breathing exercises and spending significantly more time physically active over the first 5 days after surgery compared with standard care. It was therefore recommended to progress into the multicenter phase of ICEAGE to definitively test the effect of intensive physical therapy to prevent pneumonia and improve physical recovery after emergency laparotomy. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level II.

Physiotherapy management for COVID-19 in the acute hospital setting and beyond: an update to clinical practice recommendations.

This document provides an update to the recommendations for physiotherapy management for adults with coronavirus disease 2019 (COVID-19) in the acute hospital setting. It includes: physiotherapy workforce planning and preparation; a screening tool for determining requirement for physiotherapy; and recommendations for the use of physiotherapy treatments and personal protective equipment. New advice and recommendations are provided on: workload management; staff health, including vaccination; providing clinical education; personal protective equipment; interventions, including awake proning, mobilisation and rehabilitation in patients with hypoxaemia. Additionally, recommendations for recovery after COVID-19 have been added, including roles that physiotherapy can offer in the management of post-COVID syndrome. The updated guidelines are intended for use by physiotherapists and other relevant stakeholders caring for adult patients with confirmed or suspected COVID-19 in the acute care setting and beyond.

Development of a physiotherapy-led bronchoscopy service: a regional hospital perspective.

Extended scope of practice (ESoP) and advanced scope of practice (ASoP) physiotherapy roles have been in place in the UK for over 20 years. However, interest in these types of services appears to be only just evolving within Australia. Although ESoP and/or ASoP cardiorespiratory roles in intensive care units (ICU) may be perceived to be more achievable in large metropolitan teaching hospitals, at least 67% of Australian ICUs provide physiotherapy services. Very little has been published on the practicalities (e.g. training pathways, evidence for use and guidelines) of developing advanced or extended scope cardiorespiratory physiotherapy services within Australian ICUs. This report describes the development and implementation of a physiotherapy-led bronchoscopy service from a regional hospital perspective.

Physiotherapist administered, non-invasive ventilation to reduce postoperative pulmonary complications in high-risk patients following elective upper abdominal surgery; a before-and-after cohort implementation study.

OBJECTIVES: To (1) determine whether short, 30-minute sessions of non-invasive ventilation (NIV) is associated with fewer postoperative pulmonary complications (PPC) following elective high-risk upper abdominal surgery and (2) measure feasibility and safety of this intervention when delivered by physiotherapists. DESIGN: Prospective, pre post cohort, observational, single-centre study. SETTING: Primary referral hospital in Australia. PARTICIPANTS: A total of 182 consecutive high-risk elective upper abdominal surgery patients consisting of 101 pre cohort participants compared to 81 post cohort participants. INTERVENTIONS: Both groups received standardised preoperative physiotherapy and early postoperative mobilisation. The post cohort group received five additional 30-minute NIV sessions in the first two postoperative days. MAIN OUTCOME MEASURE: Primary outcome measure was PPC incidence within the first seven postoperative days. Secondary outcomes included feasibility and safety of physiotherapy-led NIV. RESULTS: Incidence of PPC (7% vs 18%, adjusted relative risk 0.24; 95% CI 0.10 to 0.59, p=0.002) was less in the NIV group compared to those who received no NIV. Mean time to first NIV session was 18.6 (SD 11.0) hours with 74% of participants receiving NIV within 24-hours of surgery. There were no major adverse events. CONCLUSION: These findings suggest PPC reduction may be possible with postoperative NIV following high-risk elective upper abdominal surgery. Results should be seen as hypothesis-generating associations only considering the significant limitations to this study. Physiotherapy-led NIV was delivered safely to ICU and ward patients. However, the planned protocol was not feasible and appropriate physiotherapy staffing and/or a multidisciplinary approach may be required to provide this service successfully. TRIAL REGISTRATION: LIPPSMAck POP (Lung Infection Prevention Post Surgery - Major Abdominal - with Pre Operative Physiotherapy) ANZCTR-12613000664741 (for pre cohort group only).

Preoperative physiotherapy is cost-effective for preventing pulmonary complications after major abdominal surgery: a health economic analysis of a multicentre randomised trial.

QUESTION: Is preoperative physiotherapy cost-effective in reducing postoperative pulmonary complications (PPC) and improving quality-adjusted life years (QALYs) after major abdominal surgery? DESIGN: Cost-effectiveness analysis from the hospitals' perspective within a multicentre randomised controlled trial with concealed allocation, blinded assessors and intention-to-treat analysis. PARTICIPANTS: Four hundred and forty-one adults awaiting elective upper abdominal surgery attending pre-anaesthetic clinics at three public hospitals in Australia and New Zealand. INTERVENTIONS: The experimental group received an information booklet and a 30-minute face-to-face session, involving respiratory education and breathing exercise training, with a physiotherapist. The control group received the information booklet only. OUTCOME MEASURES: The probability of cost-effectiveness and incremental net benefits was estimated using bootstrapped incremental PPC and QALY cost-effectiveness ratios plotted on cost-effectiveness planes and associated probability curves through a range of willingness-to-pay amounts. Cost-effectiveness modelling utilised 21-day postoperative hospital cost audit data and QALYs estimated from Short Form-Six Domain health utilities and mortality to 12 months. RESULTS: Preoperative physiotherapy had 95% probability of being cost-effective with an incremental net benefit to participating hospitals of A$4,958 (95% CI 10 to 9,197) for each PPC prevented, given that the hospitals were willing to pay $45,000 to provide the service. Cost-utility for QALY gains was less certain. Sensitivity analyses strengthened cost-effectiveness findings. Improved cost-effectiveness and QALY gains were detected when experienced physiotherapists delivered the intervention. CONCLUSIONS: Preoperative physiotherapy aimed at preventing PPCs was highly likely to be cost-effective from the hospitals' perspective. For each PPC prevented, preoperative physiotherapy is likely to cost the hospitals less than the costs estimated to treat a PPC after surgery. Potential QALY gains require confirmation. TRIAL REGISTRATION: ACTRN12613000664741.

Physiotherapy management for COVID-19 in the acute hospital setting: clinical practice recommendations.

This document outlines recommendations for physiotherapy management for COVID-19 in the acute hospital setting. It includes: recommendations for physiotherapy workforce planning and preparation; a screening tool for determining requirement for physiotherapy; and recommendations for the selection of physiotherapy treatments and personal protective equipment. It is intended for use by physiotherapists and other relevant stakeholders in the acute care setting caring for adult patients with confirmed or suspected COVID-19.

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.

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.

Physiotherapy education and training prior to upper abdominal surgery is memorable and has high treatment fidelity: a nested mixed-methods randomised-controlled study.

OBJECTIVES: To (1) assess memorability and treatment fidelity of pre-operative physiotherapy education prior to elective upper abdominal surgery and, (2) to explore patient opinions on pre-operative education. DESIGN: Mixed-methods analysis of a convenience sample within a larger parallel-group, double-blinded, randomised controlled trial with concealed allocation and intention-to-treat analysis. SETTING: Tertiary Australian hospital. PARTICIPANTS: Twenty-nine patients having upper abdominal surgery attending pre-admission clinic within six-weeks of surgery. INTERVENTION: The control group received an information booklet about preventing pulmonary complications with early ambulation and breathing exercises. The experimental group received an additional face-to-face 30-minute physiotherapy education and training session on pulmonary complications, early ambulation, and breathing exercises. OUTCOME MEASURES: Primary outcome was proportion of participants who remembered the taught breathing exercises following surgery. Secondary outcomes were recall of information sub-items and attainment of early ambulation goals. These were measured using standardised scoring of a semi-scripted digitally-recorded interview on the 5th postoperative day, and the attainment of early ambulation goals over the first two postoperative days. RESULTS: Experimental group participants were six-times more likely to remember the breathing exercises (95%CI 1.7 to 22) and 11-times more likely (95%CI 1.6 to 70) to report physiotherapy as the most memorable part of pre-admission clinic. Participants reported physiotherapy education content to be detailed, interesting, and of high value. Some participants reported not reading the booklet and professed a preference for face-to-face information delivery. CONCLUSION: Face-to-face pre-operative physiotherapy education and training prior to upper abdominal surgery is memorable and has high treatment fidelity. TRIAL REGISTRATION: ACTRN-12613000664741.

ICEAGE (Incidence of Complications following Emergency Abdominal surgery: Get Exercising): study protocol of a pragmatic, multicentre, randomised controlled trial testing physiotherapy for the prevention of complications and improved physical recovery after emergency abdominal surgery.

Background: Postoperative complications and delayed physical recovery are significant problems following emergency abdominal surgery. Physiotherapy aims to aid recovery and prevent complications in the acute phase after surgery and is commonplace in most first-world hospitals. Despite ubiquitous service provision, no well-designed, adequately powered, parallel-group, randomised controlled trial has investigated the effect of physiotherapy on the incidence of respiratory complications, paralytic ileus, rate of physical recovery, ongoing need for formal sub-acute rehabilitation, hospital length of stay, health-related quality of life, and mortality following emergency abdominal surgery. We hypothesise that an enhanced physiotherapy care package of additional education, breathing exercises, and early rehabilitation prevents postoperative complications and improves physical recovery following emergency abdominal surgery compared to standard care alone. Methods: The Incidence of Complications following Emergency Abdominal surgery: Get Exercising (ICEAGE) trial is a pragmatic, investigator-initiated, multicentre, patient- and assessor-blinded, parallel-group, active-placebo controlled randomised trial, powered for superiority. ICEAGE will compare standard care physiotherapy to an enhanced physiotherapy care package in 288 participants admitted for emergency abdominal surgery at three Australian hospitals. Participants will be randomised using concealed allocation to receive either standard care physiotherapy (education, single session of coached breathing exercises, and daily early ambulation for 15 min) or an enhanced physiotherapy care package (education, twice daily coached breathing exercises for a minimum 2 days, and 30 min of daily supervised early rehabilitation for minimum five postoperative days). The primary outcome is a respiratory complication within the first 14 postoperative hospital days assessed daily with standardised diagnostic criteria. Secondary outcomes include referral for sub-acute rehabilitation services, discharge destination, paralytic ileus, hospital length of stay and costs, intensive care unit utilisation, 90-day patient-reported complications and health-related quality of life and physical capacity, and mortality at 30 days and at 1 year following surgery. Discussion: The morbidity, mortality, and fiscal burdens following emergency abdominal surgery are some of the worst within surgery. Physiotherapy may be an effective, low-cost, minimal harm intervention to improve outcomes and reduce hospital utilisation following this surgery type. ICEAGE will test the benefits of this commonly provided intervention within a methodologically robust, multicentre, double-blinded, active-placebo controlled randomised trial. Trial registration: ACTRN 12615000318583. Registered 8 April 2015.

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

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.