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Trial registered on ANZCTR


Registration number
ACTRN12622000839707
Ethics application status
Approved
Date submitted
21/05/2022
Date registered
15/06/2022
Date last updated
25/08/2024
Date data sharing statement initially provided
15/06/2022
Date results information initially provided
10/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Are physiotherapy treatments feasible for patients with low oxygen levels after surgery?
Scientific title
PHYSIO+++ PHYSIOtherapy management for hypoxaemia following abdominal surgery: Talk + Walk + Breathe + Non-Invasive Ventilation. A pilot feasibility randomised controlled trial.
Secondary ID [1] 304508 0
None
Universal Trial Number (UTN)
Trial acronym
PHYSIO +++
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abdominal surgery 324736 0
Hypoxaemia 324737 0
Postoperative pulmonary complication 324738 0
Condition category
Condition code
Physical Medicine / Rehabilitation 322185 322185 0 0
Physiotherapy
Surgery 323224 323224 0 0
Other surgery
Respiratory 323225 323225 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: “Talk, Walk, Breathe” and Non Invasive Ventilation (NIV)
Therapy will be delivered as individual sessions, face to face within the participants hospital bedspace or ward by qualified and registered physiotherapists of varying experience level, trained in physiotherapy-led NIV and all trial processes.

The protocolised therapy will be delivered following trial recruitment, up to and including the 7th postoperative days unless a threshold for discharge from physiotherapy is reached earlier.

Talk: a minimum of once, duration 10-minutes
Walk: daily up to and including the seventh postoperative day, 10-15mins
Breathe: a minimum of 4 sessions over two days. 1 session includes 20 deep breaths and 6 coughs. Duration of one session = 5-10 minutes.
NIV: a minimum of 4 supervised 30-minute sessions over two days following trial recruitment

For all therapy components (Talk, Walk, Breathe, NIV) adherence will be recorded on a case report form by the treating physiotherapist.

The intervention group will receive “Talk, Walk, Breathe” as described for the control group
with the following exceptions/additions.

TALK: A minimum of once, for 10 mins (5 minutes as the control group + 5 minutes for additional NIV information)
Participants will be verbally orientated to the NIV machine, circuit and interface after the first DB&C session. Participants will be educated on the potential benefit of positive pressure delivered with NIV to improve oxygen levels, increase lung volumes and sputum clearance. The booklet provided during "Talk" will be the same as the control group and not contain information about NIV.

In addition to “Talk, Walk, Breathe”, the intervention group will receive NIV.

NIV:
Supervised NIV (bilevel or CPAP) for a minimum of 4x 30 mins sessions over 2 days. Prior to each NIV session the physiotherapist will confirm the absence of any contraindication to NIV using a standardised checklist. NIV will be delivered through a face mask by a ResMed VPAP S9 machine while the patient is either sitting up in a supportive chair, or in bed with head raise elevated 45-90 degrees. For bilevel NIV application: Mode- Spontaneous/timed, Settings: Expiratory positive airway pressure (EPAP) will start then progress from 5 to 10cm of water and inspiratory positive airway pressure (IPAP) 10 to 15cm of water. The difference between IPAP and EPAP will be a minimum of 4 cm of water and back up rate of 6 breaths/minute with pressure rise time initially set at the slowest speed (900ms) and the inspiratory trigger at the minimum value. Continuous positive airway pressure (CPAP) breathing mode may be selected in place of bilevel at clinician discretion following assessment, with pressure settings 5 to 10 cm of water. Machine settings and entrained oxygen will be titrated to breathing pattern and frequency (goal <25 breaths/minute), comfort, tidal volume, and goal oxygen saturations of 92-96% unless an alternate goal oxygen saturation range is specified by the medical team. NIV machine settings and levels of oxygen entrainment will be recorded. Correct mask size and careful fitting will be used to reduce air-leak, in addition to air-leaks being monitored and recorded. The participant may remove, or request assistance to remove the NIV mask at any time for any reason. Temporary mask removal will be encouraged should coughing result in sputum expectoration which is not immediately swallowed. If the participant is unable or unwilling to continue NIV therapy within 5 mins of a break, the session will be terminated, and the reason documented. If the participant remains unable to tolerate the therapy despite titration and reassurance, cessation of NIV therapy will occur for that session and be reported.

Order of therapies:
1. TALK - as control group
2. WALK - as control group
2. BREATHE - as the control group
3. TALK - NIV specific information
4. NIV

As the control group: High flow oxygen therapy (HFOT) use may be prescribed at any time by the medical team in line with local practise. Timing of initiation and duration of HFOT will be recorded but not protocolised.
Intervention code [1] 322487 0
Prevention
Intervention code [2] 322488 0
Rehabilitation
Intervention code [3] 323291 0
Treatment: Other
Comparator / control treatment
Brief name: “Talk, Walk, Breathe”
Therapy will be delivered as individual sessions, face to face within the participants hospital bedspace or ward, by qualified and registered physiotherapists of varying experience level trained in trial processes and therapy.
The protocolised therapy will be delivered following trial recruitment, up to and including the 7th postoperative days unless a threshold for discharge from physiotherapy is reached earlier.
For all therapy components (Talk, Walk, Breathe) adherence will be recorded on a case report form by the treating physiotherapist.

A booklet will be provided to participants containing written and pictorial information regarding postoperative pulmonary complications (PPC) and their potential prevention with early ambulation and breathing exercises to consolidate the learnt knowledge from verbal education and training. The booklet was adapted from an existing booklet used in trials for a similar patient population and previously assessed for patient acceptability and readability (Boden 2018, Physiotherapy).

Talk: a minimum of once, duration 5-minutes
Walk: daily up to and including the seventh postoperative day, 10-15mins
Breathe: a minimum of 4 sessions over two days. 1 session includes 20 deep breaths and 6 coughs. Duration 5-10 minutes

“TALK”: Minimum 1 session
During the first therapy session following trial recruitment, the patient is informed of the risk of postoperative complications due to surgery and prolonged bed rest impairing their lungs and muscles. Education aims to inform, motivate, encourage, and inspire participation in exercises as prescribed. An information booklet provides a written record of what was verbally taught. Education sessions may be repeated if the participant is unable to recall the information on the second review.
Recall test: from the second postoperative day, the treating physiotherapist will confirm the participants retention of information by asking – "Can you remember the breathing and walking/exercises that I asked you to keep doing by yourself? What were they?" If the participant is unable to remember the independent exercise program, an additional education sessions or reminder/prompts may be given. No further education is required if the participant has accurate recall (participant may refer to written materials for accurate recall).
“WALK”: daily physiotherapist supervised ambulation, at least 10 and no more than 15mins, once daily
Duration –minimum of 10 and no more than 15-minutes of total worktime
Frequency – once daily, however a subsequent session may occur if the initial walk/exercise time does not reach the 10-minute minimum work time. Total time should not exceed 15mins.
Intensity – Aim for rating of perceived exertion >3/10 or breathing deeper than at rest.
Type – Continuous activity aiming for 10-15 minutes if patient can tolerate. Allowable to train in intervals with work/rest ratio at least 1:1. Rest periods are subtracted from the total time.
Mode – Functional exercise program starting with ambulation. At every session the participant will be progressed sequentially through the protocol stages aiming to achieve a walking time of at least 10-minutes, but no more than 15-minutes. Successful ambulation is defined as continuously marching on the spot beside the bed or walking away from the bedside for more than one minute. If a participant is unable to participate in upright ambulation, then non-ambulatory physical activity is continued to be provided until at least the minimum 10-minutes of activity time is achieved. The physiotherapist may return for a second session if the minimum time of 10 minutes is not achieved in the first session. Physical activity is provided in a sequential step-down process starting with the highest activity possible and moving to less intense. These exercises consist of chair or bed based progressive low resistance, high repetition, lower and upper limb exercises of 3-4 sets as prescribed by the treating physiotherapist based on the individual patient’s requirements and functional ability. Physiotherapists can incorporate specific functional exercises (for example a stairs assessment) to target identified individual physical impairments, within the walk/exercise protocol as long as the exercises comply with the goal intensity, duration, and type. Completion of functional activities not listed in the exercise hierarchy will be recorded.
“BREATHE”: Twice daily for at least the first two postoperative days following trial recruitment
Twice daily from the first postoperative physiotherapy review following trial recruitment, coached deep breathing and cough (DB&C) exercises performed in upright sitting for a minimum of four sessions. Two sets of 10 slow-flow breaths to maximum inspiratory capacity with two to three inspiratory sniff breath stacking manoeuvres at the end of each deep breath, followed by a 3 to 5 second breath hold. An open mouth during exhalation should be encouraged to optimise unobstructed expiratory flow and the instruction to “let the air rush out of your lungs with your mouth open” be given, though forceful abdominal contraction during exhalation discouraged. Each set of 10 breaths are followed by three supported coughs or forced expiratory technique with an open glottis called a “huff”. A small towel is pressed over the abdominal incision during supported cough/huff to encourage greater expiratory force. Additional sessions may be provided if the participant is unable to recall the exercises, is unable to perform exercises independently or has ongoing hypoxaemia. The number, time and reason for additional sessions will be recorded. Independent continuation of 20 repetitions of deep breaths and six coughs will be prescribed to be performed hourly during the day until the patient is ambulant out of bed at least four times a day, for a minimum of five minutes at a time. Physiotherapists may tailor the DB sets to achieve the total reps (20) in response to breathlessness. For example, instead of two sets of 10, four sets of five DB may be used. This titration will be recorded if and when it occurs.
Adherence to interventions will be recorded and reported by ward physiotherapists in the ward physiotherapist case report form and include the number, timing (which post operative day and time of treatment), completeness (number of sets/reps, duration) and reasons for non-adherence to protocol of therapy sessions for “Talk, Walk and Breathe”.

Order of therapies:
1. TALK
2. WALK
3. BREATHE

High flow oxygen therapy (HFOT) use may be prescribed at any time by the medical team in line with local practise. Timing of initiation and duration of HFOT will be recorded but not protocolised.
Control group
Active

Outcomes
Primary outcome [1] 329952 0
Accrual - the rate of patient recruitment (number of patients recruited to the trial per week) as determined by an audit of study screening and enrolment logs.
Timepoint [1] 329952 0
The duration of the trial
Primary outcome [2] 331034 0
Adherence to protocol - the total physiotherapist-led NIV time delivered (minutes) from enrolment until a trial end-point is met as determined by an audit of ward physio case report form
Timepoint [2] 331034 0
Within the first 7 postoperative days
Primary outcome [3] 331035 0
Safety - The incidence of adverse events during or within 15mins following physiotherapy interventions as determined by clinical assessment recorded in the ward physiotherapist case report form and data in medical records.
Examples of adverse events are physiological changes (blood pressure, heart rate or rhythm changes, oxygenation) or significant patient reported events (pain/claustrophobia/vomiting).
Timepoint [3] 331035 0
Within the first seven postoperative days
Secondary outcome [1] 404400 0
PRIMARY OUTCOME #4
Acceptability to participants of trial therapies collected as recorded with a customised acceptability questionnaire using domains from the Theoretical Framework of Acceptability.
Timepoint [1] 404400 0
On postoperative day 5 to 7 or prior to discharge from hospital - whichever occurs first.
Secondary outcome [2] 410140 0
PRIMARY OUTCOME #5
Acceptability to clinicians of trial therapies collected as recorded with a customised acceptability questionnaire using domains from the Theoretical Framework of Acceptability.
Timepoint [2] 410140 0
Within 7 days of first providing the trial protocol and a second survey on completion of the trial.
Secondary outcome [3] 410141 0
Time to recruitment following surgery (the number of hours following surgical anaesthetic stop time to allocation to a group) as determined by an audit of study enrolment logs and medical records.
Timepoint [3] 410141 0
Within the first 3 postoperative days
Secondary outcome [4] 410144 0
Number of physiotherapy-led NIV sessions delivered as determined by ward physiotherapist case report forms and medical notes.
Timepoint [4] 410144 0
Within 7 postoperative days
Secondary outcome [5] 410721 0
Reasons for NIV sessions not delivered to protocol as determined by ward physiotherapist case report forms and medical notes
Timepoint [5] 410721 0
Within 7 postoperative days
Secondary outcome [6] 410722 0
Reasons for additional NIV sessions as determined by ward physiotherapist case report forms and medical notes
Timepoint [6] 410722 0
Within 7 postoperative days
Secondary outcome [7] 410723 0
Total number of Breathe repetitions delivered as determined by ward physiotherapist case report forms and medical notes
Timepoint [7] 410723 0
Within 7 postoperative days
Secondary outcome [8] 410724 0
Reasons for additional Breathe repetitions as determined by ward physiotherapist case report forms and medical notes
Timepoint [8] 410724 0
Within 7 postoperative days
Secondary outcome [9] 410725 0
Reasons for Walk not delivered to protocol as determined by ward physiotherapist case report forms and medical notes
Timepoint [9] 410725 0
Within 7 postoperative days
Secondary outcome [10] 410726 0
Incidence and time from surgical anaesthetic end time to composite postoperative pulmonary complication -Abbott definition
Composite of respiratory diagnoses that share common pathophysiological mechanisms including pulmonary collapse and airway contamination:
(i) atelectasis detected on computed tomography or chest radiograph,
(ii) pneumonia using US Centers for Disease Control criteria,
(iii) Acute Respiratory Distress Syndrome using Berlin consensus definition,
(iv) pulmonary aspiration (clear clinical history AND radiological evidence)

as determined by clinical assessment, study case report forms and medical records, imaging and laboratory reports
Timepoint [10] 410726 0
Within 7 postoperative days
Secondary outcome [11] 410727 0
Incidence and time from surgical anaesthetic end time to composite Postoperative Pulmonary Complication - Melbourne Group Score (MGS) v3
When four (4) or more criteria are present within a 24-hour period on a single postoperative day
1. Chest radiograph (CXR) report of collapse/consolidation
2. Raised maximum tympanic temperature greater than 38 ?C on more than one consecutive postoperative day
3. Pulse oximetry oxyhaemoglobin saturation (Sp02) less than 90% on room air on more than one consecutive postoperative day. Where the fraction of inhaled oxygen is >0.5, SpO2 will be assumed to be <90% on air without testing on air.
4. Production of yellow or green sputum different to preoperative assessment
5. Presence of infection on sputum culture report
6. An otherwise unexplained white cell count greater than 11 x109/L.
7. New abnormal breath sounds on auscultation different to preoperative assessment
8. Physician’s diagnosis of PPC (e.g. atelectasis, pneumonia, acute exacerbation of COPD, respiratory failure, upper respiratory tract infection) OR prescription of an antibiotic specific for respiratory infection.
If a nurse, physician, or physiotherapist documents in the medical record the occurrence of a criterion at any time in the 24hr time period, this is taken as a positive finding. If no documentation an assessor should ideally assess this directly.
If daily measures are not made for CXR or sputum samples, a positive diagnosis for either of these criteria is to be carried over to the next consecutive postoperative day.

as determined by clinical assessment, study case report forms and medical records, imaging and laboratory reports
Timepoint [11] 410727 0
Within 7 postoperative days
Secondary outcome [12] 410728 0
Incidence and time from surgical anaesthetic end time to Pneumonia
Pneumonia diagnosis:
Infiltrates on chest imaging and,
At least two of :
Temperature >38 degrees C, Short of breath, cough and purulent sputum, altered respiratory auscultation, and WCC >12,000/Ul or leukopenia <3000/Ul

as determined by clinical assessment, study case report forms and medical records, imaging and laboratory reports
Timepoint [12] 410728 0
Within 7 postoperative days
Secondary outcome [13] 410729 0
Composite measure of the incidence and timing of intubation and mechanical ventilation for respiratory reasons or continuous (>1hr continuous delivery) non-invasive positive pressure therapy (either CPAP or bilevel) after trial recruitment.

as determined by medical records
Timepoint [13] 410729 0
After trial recruitment and within 30 days of surgery.
Secondary outcome [14] 410730 0
Reason for intubation or continuous CPAP/NIV initiation after trial recruitment as determined by medical records.
Timepoint [14] 410730 0
After trial recruitment and within 30 days of surgery.
Secondary outcome [15] 410731 0
Change in ROX (Respiratory rate- Oxygenation) index pre/post physiotherapy sessions as determined by data from ward physiotherapist case report form.
ROX index = The ratio of oxygen saturation/fraction of inspired oxygen to respiratory rate
ROX index = (SpO2/FiO2) / RR
Timepoint [15] 410731 0
The first two postoperative days following trial recruitment
Secondary outcome [16] 410732 0
Change in peak cough flow (PCF) prior to and following physiotherapy treatment as determined by data from ward physiotherapist case report form
Timepoint [16] 410732 0
The first two postoperative days following trial recruitment
Secondary outcome [17] 410733 0
Change in patient reported activity - Duke Activity Status Index (DASI)
Timepoint [17] 410733 0
Pre and 90 days postop
Secondary outcome [18] 410735 0
Change in patient reported quality of life using the EUROQOL 5D (EQ5D)
Timepoint [18] 410735 0
Pre, postoperative day 5-7 and 90 days postop
Secondary outcome [19] 410736 0
Postoperative acute hospital length of stay (LOS) as determined by review of medical records
Timepoint [19] 410736 0
During index acute hospital admission, consecutive days up to the 90th postoperative day
Secondary outcome [20] 410737 0
Intensive care unit postoperative LOS as determined by review of medical records
Timepoint [20] 410737 0
During index acute hospital admission, consecutive days up to the 90th postoperative day
Secondary outcome [21] 410738 0
Number of days alive and out of hospital at 90 days as determined by follow up telephone interview with patients and or review of medical records
Timepoint [21] 410738 0
90 days following the operation
Secondary outcome [22] 410739 0
Composite measure of patient reported complications at 90 days as determined by follow up telephone interview with patients and or review of medical records.
Patient reported complications:
Hospitalisation following discharge, hospital visit or GP visit for complications including
1. PE/DVT
2. Respiratory
3. Cardiac
4. Surgical/wound complication
5. Gastrointestinal disturbance
6. Fatigue/tiredness/weakness
Timepoint [22] 410739 0
90 days following the operation
Secondary outcome [23] 410747 0
In hospital mortality as determined by review of medical records
Timepoint [23] 410747 0
During hospital admission up to the 90th postoperative day
Secondary outcome [24] 410748 0
Mortality at 90 postoperative days as determined by follow up phone interview and review of medical records
Timepoint [24] 410748 0
90 postoperative days
Secondary outcome [25] 417641 0
Number of days alive and out of hospital at 30 days as determined by follow up telephone interview with patients and or review of medical records
Timepoint [25] 417641 0
30 days following the operation
Secondary outcome [26] 426573 0
Time from screened as eligible to allocation to a group (minutes) as recorded in medical or trial screening and recruitment records.
Timepoint [26] 426573 0
Within the first 3 postoperative days.
Secondary outcome [27] 426574 0
Duration of any physiotherapist-led NIV protocol session (minutes) as assessed with a stopwatch and recorded in the clinician case report form
Timepoint [27] 426574 0
Within 7 postoperative days.
Secondary outcome [28] 426575 0
Reason Breathe sessions not delivered to protocol as recorded in the clinician case report form.
Timepoint [28] 426575 0
Within 7 postoperative days
Secondary outcome [29] 426576 0
Total number of Walk sessions delivered as recorded in the clinician case report form.
Timepoint [29] 426576 0
Within 7 postoperative days.
Secondary outcome [30] 426577 0
Daily incidence of persistent hypoxaemia (SpO2 <90% on air) as reported in medical records and clinician case report forms.
Timepoint [30] 426577 0
From the day following trial enrolment, daily within 7 postoperative days.
Secondary outcome [31] 426578 0
Change in severity of PPC (Abbott definition - severity pre-defined)
Timepoint [31] 426578 0
Within 7 postoperative days.
Secondary outcome [32] 426579 0
Change in severity of PPC (Melbourne Group Score v3) measured as a count of positive diagnostic elements (count of positive elements 4-8 out of a possible 8. 4/8 is the least severe and 8/8 the most severe)
Timepoint [32] 426579 0
Within 7 postoperative days.
Secondary outcome [33] 426580 0
Change in severity of Pneumonia diagnosis (count of positive elements 3-6 out of a possible 6. 3/6 is the least severe and 6/6 is the most severe.
Timepoint [33] 426580 0
Within 7 postoperative days
Secondary outcome [34] 426581 0
Incidence of acute hospital re-admission at 30 postoperative days assessed from medical records and participant self-report at the 3 month follow up phone call
Timepoint [34] 426581 0
Within 30 postoperative days
Secondary outcome [35] 426582 0
Reason for acute hospital re-admission at 30 postoperative days assessed from medical records and participant self-report at the 3 month follow up phone call-
Timepoint [35] 426582 0
Within 30 postoperative days
Secondary outcome [36] 426583 0
Incidence of acute hospital re-admission at 90 postoperative days assessed from medical records and participant self-report at the 3 month follow up phone call.
Timepoint [36] 426583 0
Within 90 postoperative days
Secondary outcome [37] 426584 0
Reason for acute hospital re-admission within 90 postoperative days assessed from medical records and participant self-report at the 3 month follow up phone call.
Timepoint [37] 426584 0
90 postoperative days
Secondary outcome [38] 426585 0
Mortality at 30 postoperative days as determined by follow up phone interview and review of medical records
Timepoint [38] 426585 0
30 postoperative days
Secondary outcome [39] 426586 0
Incidence and timing of postoperative ICU re/admission assessed with medical records.
Timepoint [39] 426586 0
Following trial enrolment and within 30 postoperative days
Secondary outcome [40] 426587 0
Costs to provide trial therapies including the physiotherapists wage and the cost of non-invasive ventilation consumables as determined from hospital records
Timepoint [40] 426587 0
Within 7 postoperative days

Eligibility
Key inclusion criteria
Major elective or non-elective abdominal surgery (open abdominal incision >5cm, or when anesthetic time >3 hours: laparoscopy or robotic surgery to the abdomen), extubated within 24hrs of surgery, age greater than or equal to 18 years, hypoxaemia while self-ventilating via a natural airway at least 3 hours after extubation and within 72 hours following abdominal surgery. Hypoxaemia is defined by a positive Air Test 90 (oxyhaemoglobin saturations <90% within 2 minutes of breathing room air) or if the Air Test 90 is not able to be conducted, a ratio of partial pressure of oxygen to fraction of inspired oxygen <300, where an arterial blood gas is available.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to collaborate due to language or severe cognitive impairment, pregnancy, oesophagectomy, tracheostomy, previously participated in PHYSIO+++, current enrolment in a trial with similar therapies or outcomes, patients managed under airborne or droplet precautions, preoperative muscle weakness necessitating assistance to cough (for example a neuromuscular disorder or spinal cord injury), refusal to participate, not able to be recruited within 8 hours of screening as eligible, and those who do not receive medical clearance to participate in the trial due to (a) imminent (anticipated within 12hours of study inclusion) surgery, palliation, reintubation or the need for continuous medically prescribed NIV/CPAP (b) profound respiratory failure or cardiovascular instability (c) NIV contraindicated.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following screening for eligibility, participants will be randomly allocated 1:1 to one of two groups, control or intervention, via concealed allocation through the online trial REDCap database. The principal investigator will access the REDCap trial program to generate then advise the treating physiotherapist of group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated via concealed allocation through the trial REDCap database. An independent database administrator will upload the randomisation schedule.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Prospective, single centre, pilot, parallel group randomised active-placebo controlled trial with concealed allocation (1:1) and assessor blinding.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Flow through the trial will be presented in a CONSORT diagram, including number eligible/ineligible, number approached to participate, number randomised, and dropouts. Collected data will be presented using descriptive statistics in the first instance, summarised as a total and by treatment group. Continuous data will be summarised by mean and standard deviation if normally distributed, and median and inter-quartile range if non-normally distributed. Categorical data will be summarised using frequencies and proportions. Treatment groups will be compared using t-tests, chi-square tests, and their non-parametric equivalents if necessary. The primary outcome of trial feasibility and therapy delivery will be assessed through counts of patient recruitment, adherence to protocol by comparing total NIV time delivered, and acceptability questionnaires. Secondary explorative outcomes will be assessed using both repeated measures and time-to-event analyses depending on the outcome. Primary models of interest will be unadjusted and carried out according to the intention-to-treat principle. A second model adjusting for known covariates of interest, including direct ICU admission following surgery, emergency surgery, current smoker, and respiratory comorbidities, will also be performed. Depending on data distribution, per protocol analyses may be conducted to explore if there is an interaction between dosage and outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/01/2023
Actual
20/01/2023
Date of last participant enrolment
Anticipated
14/07/2023
Actual
15/08/2023
Date of last data collection
Anticipated
13/10/2023
Actual
13/10/2023
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21361 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 36253 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 308874 0
Government body
Name [1] 308874 0
Metro South Health Research Support Scheme Grant
Country [1] 308874 0
Australia
Primary sponsor type
Government body
Name
Metro South Health
Address
199 Ipswich Rd
Woolloongabba
4102 Queensland
Country
Australia
Secondary sponsor category [1] 313054 0
None
Name [1] 313054 0
Address [1] 313054 0
Country [1] 313054 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308779 0
Metro South Hospital and Health Services
Ethics committee address [1] 308779 0
Level 7, Translational Research Institute Building
Princess Alexandra Hospital
Ipswich Road, Woolloongabba Qld 4102
Ethics committee country [1] 308779 0
Australia
Date submitted for ethics approval [1] 308779 0
18/11/2021
Approval date [1] 308779 0
08/04/2022
Ethics approval number [1] 308779 0
HREC/2021/QMS/77244

Summary
Brief summary
Following abdominal surgery, low oxygen levels are common and may be an early sign of breathing complications. Physiotherapy treatments following surgery may improve oxygen levels and prevent breathing complications. Physiotherapy treatments often include early walking, deep breathing exercises, education about the best things a patient can do themselves to help recovery, and sometimes assisted breathing with a machine. We hypothesize that it is feasible to deliver physiotherapy treatments including education, breathing exercises, early walking, and non-invasive ventilation to patients with low oxygen levels following abdominal surgery.
Trial website
Trial related presentations / publications
Public notes
Additional details for the Abbott definition of postoperative pulmonary complication composite outcome, and severity ratings for the Melbourne Group Score and Pneumonia outcomes

PPC (Abbott definition) Severity
None: planned use of supplemental oxygen or mechanical respiratory support as part of routine care, but not in response to a complication or deteriorating physiology. Therapies which are purely preventive or prophylactic for example high flow nasal oxygen or continuous positive airways pressure (CPAP) should be recorded as none
Mild: therapeutic supplemental oxygen <0.6 FiO2
Moderate: therapeutic supplemental oxygen _0.6 FiO2, requirement for high-flow nasal oxygen, or both
Severe: unplanned non-invasive mechanical ventilation, CPAP, or invasive mechanical ventilation requiring tracheal intubation

Abbott PPC diagnosis - further details for diagnosis of ARDS and Pneumonia
Berlin definition of Acute Respiratory Distress Syndrome
Timing within 1 week of a known clinical insult or new or worsening respiratory symptoms AND….
Chest imaging: bilateral opacities not fully explained by effusions, lobar/lung collapse or nodules AND…
Origin of oedema: respiratory failure not fully explained by cardiac failure or fluid overload (requires objective assessment eg. echocardiography, to exclude hydrostatic oedema), AND….
Oxygenation:
mild PaO2:FiO2 between 200-300 mm Hg with PEEP or PAP =5 cm H2O;
moderate PaO2:FiO2 between 100-200 mm Hg with PEEP=5 cmH2O;
severe PaO2:FiO2 = 100 mm Hg with PEEP =5 cm H2O.

US Centers for Disease Control (CDC) Pneumonia definition
Two or more of serial chest radiographs with at least one of the following (one radiograph is sufficient for patients with no underlying pulmonary or cardiac disease):
(i) New of progressive and persistent infiltrates
(ii) Consolidation
(iii) Cavitation
AND at least one of the following:
a) Fever (>38?C) with no other recognised cause.
b) Leucopaenia (white cell count <4 x 109 litre-1) or leucocytosis (white cell count >12 x 109 litre-1),
c) For adults >70 yr old, altered mental status with no other recognised cause;
AND at least two of the following;
a) New onset of purulent sputum or change in character of sputum, or increased respiratory secretions, or increased suctioning requirements,
b) New onset or worsening cough, or dyspnoea, or tachypnoea,
c) Rales or bronchial breath sounds,
d) Worsening gas exchange (hypoxaemia, increased oxygen requirement, increased ventilator demand).

Severity measure for Melbourne Group Score PPC
Score between 4 (least severe) and 8 (most severe) out of 8. 1 point for each of the 8 criteria. A score less than 4 indicates a PPC is not present.
1. Chest radiograph (CXR) report of collapse/consolidation
2. Raised maximum tympanic temperature greater than 38 ?C on more than one consecutive postoperative day
3. Pulse oximetry oxyhaemoglobin saturation (Sp02) less than 90% on room air on more than one consecutive postoperative day. Where the fraction of inhaled oxygen is >0.5, SpO2 will be assumed to be <90% on air without testing on air.
4. Production of yellow or green sputum different to preoperative assessment
5. Presence of infection on sputum culture report
6. An otherwise unexplained white cell count greater than 11 x109/L.
7. New abnormal breath sounds on auscultation different to preoperative assessment
8. Physician’s diagnosis of PPC (e.g. atelectasis, pneumonia, acute exacerbation of COPD, respiratory failure, upper respiratory tract infection) OR prescription of an antibiotic specific for respiratory infection.

Severity measure for independent Pneumonia diagnosis
Score between 3 (least severe) and 6 (most severe) out of 6. 1 point for each of the 6 criteria. A score less than 3 or without the compulsory criteria indicates Pneumonia is not present.
1. Infiltrates on chest imaging (compulsory criteria)
2. Temperature >38 degrees C
3. Short of breath
4. Cough and purulent sputum
5. Altered respiratory auscultation
6. White cell count >12,000 Ul or leukopenia <3000 Ul

Contacts
Principal investigator
Name 111854 0
Ms Claire Hackett
Address 111854 0
Physiotherapy Department
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba
Qld 4102
Country 111854 0
Australia
Phone 111854 0
+61401421636
Fax 111854 0
Email 111854 0
[email protected]
Contact person for public queries
Name 111855 0
Claire Hackett
Address 111855 0
Physiotherapy Department
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba
Qld 4102
Country 111855 0
Australia
Phone 111855 0
+61401421636
Fax 111855 0
Email 111855 0
[email protected]
Contact person for scientific queries
Name 111856 0
Claire Hackett
Address 111856 0
Physiotherapy Department
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba
Qld 4102
Country 111856 0
Australia
Phone 111856 0
+61401421636
Fax 111856 0
Email 111856 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the deidentified IPD collected during the trial as specified in the protocol.
When will data be available (start and end dates)?
2 years from date of main result publication with no end date determined
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor primarily based on the methodological quality of the proposal for data utilisation.
Available for what types of analyses?
To achieve the aims in the approved proposal, including IPD meta-analyses
How or where can data be obtained?
Access subject to data sharing agreement and ethical/institutional review board clearance to share deidentified data. Please email the principal investigator ([email protected]) with requests


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePHYSIO+++: protocol for a pilot randomised controlled trial assessing the feasibility of physiotherapist-led non-invasive ventilation for patients with hypoxaemia following abdominal surgery.2023https://dx.doi.org/10.1136/bmjopen-2023-078175
N.B. These documents automatically identified may not have been verified by the study sponsor.