Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000269336
Ethics application status
Approved
Date submitted
14/02/2017
Date registered
22/02/2017
Date last updated
15/06/2021
Date data sharing statement initially provided
12/03/2019
Date results information initially provided
12/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
NIPPER-PLUS: Does intermittent non-invasive ventilation prevent postoperative pulmonary complications following major upper abdominal surgery?
Scientific title
Does additional twice-daily 30-minute Non-Invasive Ventilation (NIV) sessions in the first two days following elective upper abdominal surgery (UAS) prevent respiratory complications in high-risk adults when compared to humidified high-flow nasal prong (HFNP) oxygen therapy alone? A pilot randomised controlled trial.
Secondary ID [1] 291183 0
Nil
Universal Trial Number (UTN)
U1111-1193-0074
Trial acronym
NIPPER-PLUS: Non-Invasive Positive airway Pressure thErapy to Reduce Postoperative Lung complications following Upper abdominal Surgery
Linked study record
ACTRN12613000664741 LIPPSMAck POP is a parent study

Health condition
Health condition(s) or problem(s) studied:
Postoperative pulmonary complication 302065 0
Condition category
Condition code
Surgery 301699 301699 0 0
Other surgery
Anaesthesiology 301700 301700 0 0
Other anaesthesiology
Respiratory 301701 301701 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Extubation post-surgery onto high flow nasal prongs (HFNP) which will have fraction of inspired oxygen (FiO2) titrated to achieve a peripheral oxygenation (SpO2) of between 92-96% unless otherwise specified by attending anaesthetist (i.e. severe COPD). Gas flow rate will be set at 50l/min and can be decreased to a minimum of 30l/min if the patient requires for tolerance. HFNP is to be provided continuously from end of surgery (Day 0) to 48 hours later (Day 2).
The intervention group will get an additional single 30-minute Bi-Level Positive Airway Pressure Non-Invasive Ventilation (BiPAP-NIV) session within four hours of extubation by either the attending anaesthetist or the specialist surgical physiotherapist (Day 0) then twice daily, 30-minute sessions of BiPAP-NIV on Day 1 and Day 2 with a Physiotherapist.
BiPAP NIV will be delivered via facemask by a VPAP Resmed machine. This will be carried out with patients either sitting up in bed with the head of bed raised between 45 – 90 degrees as tolerated or sitting out of bed in a high back chair. Expiratory positive airway pressure (EPAP) will be set at 10cmH20. Inspiratory positive airway pressure (IPAP) will be initially set at 15cmH20 and adjusted as required to achieve tidal volumes of at least 6-8mls/kg. Participants with BMI > 30 will have a starting EPAP set at 12cmH20 and a starting IPAP set at 16cmH20. The difference between IPAP and EPAP (known as pressure support ventilation (PSV)) will be a minimum of 4cmH20 and the maximum total pressure (PSV + EPAP) will be no greater than 25cmH20. If a participant is unable to tolerate the set pressures, reassurance will firstly be given to the participant and the following modifications will be taken in sequential order, until patient tolerance is achieved:
1. Reduce EPAP to 8cmH20 (set minimum)
2. Reduce IPAP to 12cmH20 (set minimum) in decrements of 1cmH20.
If the participant remains unable to tolerate the therapy despite pressure titration and reassurance, cessation of NIV therapy will occur and will be reported.
Pressure rise time will be set at the slowest speed (900ms) and the inspiratory trigger will be set at the minimum value. Inspired gases will be heated and humidified via the VPAP Resmed machine. Air-leaks will be managed by fitting the correct size mask carefully with focus on leaks around the nasogastric tube. Any air leak will be monitored and recorded. Fi02 will be titrated to achieve Sp02 >92-96% unless otherwise specified by the medical team (i.e. COPD). The patient will be continuously monitored by the treating physiotherapist for the duration of the therapy and again at 30-minutes post BiPAP-NIV.
Pre-operative physiotherapy education session (Boden et al, ACTRN12613000664741.) and post-op early ambulation protocol (Boden et al,) will be provided as per the LIPPSMAck-POP trial intervention group (ACTRN12613000664741).
One (1) 20-30 minute pre-operative education session delivered by a Physiotherapist at the standard outpatient Pre-Admission Clinic appointment. The education is to be provided within 6 weeks of the schedued operation date and will be performed in person, however, if this is not possible, the patient will be contacted by phone and provided with the education and training via telephone and the booklet sent via mail. The pre-operative physiotherapy session will consist of education on the prevention of post-operative pulmonary complications stressing the importance of early post-operative ambulation and the performance of self-directed deep breathing and coughing (DB&C) exercises immediately from waking from the operation. Patients will be informed that the further they walk and the more often they walk away from the bedside each day following their operation the better their chance of avoiding serious post-operative complications (chest infection or deep vein thrombosis). They will be informed that a Physiotherapist will see them on the first post-operative day and assist them out of bed to walk as far as possible. They will be told that they will be walking at a pace that gets them a bit breathless and will be familiarised with the 0-10 Borg scale Rating of Perceived Exertion (RPE). They will be told that each time they walk it should feel like a 3-4/10 in exertion. After the first post-operative day session with the Physiotherapist they will be encouraged strongly to walk or exercise by their bedside as often as they can by themselves or with the assistance of a nurse or carer.
As it is frequently not possible to ambulate as early and as often as recommended, participants will be encouraged (during the pre-operative intervention) to perform self-directed breathing exercises to protect their lungs during this time in bed. They will be instructed to perform the DB&C exercises immediately from waking from the anaesthetic and then every hour during daytime waking hours until their first ambulation session, and then at any time when they are not ambulant. The physiotherapist will then coach each participant in at least three repetitions, and as many as required to master technique, of two sets of 10 slow-flow breaths to maximum inspiratory capacity with two to three inspiratory sniff breath stacking manoeuvres. Each breath is held for three to five seconds. Each set of 10 breaths are followed by three coughs, or a forced expiratory technique with an open glottis called a “huff”, with a small firm pillow pressed over on the abdominal incision to support the wound and to encourage greater expiratory force. Participants will be encouraged to practice these exercises prior to their operation to develop familiarity. Each patient in the intervention group will be given an estimate of their likelihood of getting a PPC based on available pre-operative information (type of procedure proposed, booked post-operative admission to ICU, usual length of procedure, respiratory co-morbidity, self rated fitness levels, current smoker). Patients will be informed that aggressive early self directed DB & C exercises and ambulation is effective in reducing this known risk of a PPC. Participants will be provided with an accompanying education booklet outlining what was presented on prevention of PPC, post-operative physiotherapy, early ambulation, self directed DB&C (2 sets of 10 DB followed by 3 coughs every hour during daytime) and the expected recovery process. Post-operatively participants will be provided with a standardised physiotherapy assisted early mobilisation program and reminded to do the DB&C exercises as per the booklet provided. No further coached respiratory physiotherapy is provided.
To reduce confounding variables no other pre- or post-operative respiratory physiotherapy will be provided.
Intervention code [1] 297184 0
Treatment: Devices
Intervention code [2] 297185 0
Prevention
Comparator / control treatment
Extubation post-surgery onto high flow nasal prongs (HFNP) which will have fraction of inspired oxygen (FiO2) titrated to achieve an peripheral oxygenation (SpO2) of between 92-96% unless otherwise specified by attending anaesthetist (i.e. severe COPD). Gas flow rate will be set at 50l/min and can be decreased to a minimum of 30l/min if the patient requires for tolerance. HFNP is to be provided continuously from end of surgery (Day 0) to 48 hours later (Day 2).
Pre-operative physiotherapy education session (Boden et al, ACTRN12613000664741.) and post-op early ambulation protocol (Boden et al,) will be provided as per the LIPPSMAck-POP trial intervention group (ACTRN12613000664741).
One (1) 20-30 minute pre-operative education session delivered by a Physiotherapist at the standard outpatient Pre-Admission Clinic appointment. The education is to be provided within 6 weeks of the schedued operation date and will be performed in person, however, if this is not possible, the patient will be contacted by phone and provided with the education and training via telephone and the booklet sent via mail. The pre-operative physiotherapy session will consist of education on the prevention of post-operative pulmonary complications stressing the importance of early post-operative ambulation and the performance of self-directed deep breathing and coughing (DB&C) exercises immediately from waking from the operation. Patients will be informed that the further they walk and the more often they walk away from the bedside each day following their operation the better their chance of avoiding serious post-operative complications (chest infection or deep vein thrombosis). They will be informed that a Physiotherapist will see them on the first post-operative day and assist them out of bed to walk as far as possible. They will be told that they will be walking at a pace that gets them a bit breathless and will be familiarised with the 0-10 Borg scale Rating of Perceived Exertion (RPE). They will be told that each time they walk it should feel like a 3-4/10 in exertion. After the first post-operative day session with the Physiotherapist they will be encouraged strongly to walk or exercise by their bedside as often as they can by themselves or with the assistance of a nurse or carer.
As it is frequently not possible to ambulate as early and as often as recommended, participants will be encouraged (during the pre-operative intervention) to perform self-directed breathing exercises to protect their lungs during this time in bed. They will be instructed to perform the DB&C exercises immediately from waking from the anaesthetic and then every hour during daytime waking hours until their first ambulation session, and then at any time when they are not ambulant. The physiotherapist will then coach each participant in at least three repetitions, and as many as required to master technique, of two sets of 10 slow-flow breaths to maximum inspiratory capacity with two to three inspiratory sniff breath stacking manoeuvres. Each breath is held for three to five seconds. Each set of 10 breaths are followed by three coughs, or a forced expiratory technique with an open glottis called a “huff”, with a small firm pillow pressed over on the abdominal incision to support the wound and to encourage greater expiratory force. Participants will be encouraged to practice these exercises prior to their operation to develop familiarity. Each patient in the intervention group will be given an estimate of their likelihood of getting a PPC based on available pre-operative information (type of procedure proposed, booked post-operative admission to ICU, usual length of procedure, respiratory co-morbidity, self rated fitness levels, current smoker). Patients will be informed that aggressive early self directed DB & C exercises and ambulation is effective in reducing this known risk of a PPC. Participants will be provided with an accompanying education booklet outlining what was presented on prevention of PPC, post-operative physiotherapy, early ambulation, self directed DB&C (2 sets of 10 DB followed by 3 coughs every hour during daytime) and the expected recovery process. Post-operatively participants will be provided with a standardised physiotherapy assisted early mobilisation program and reminded to do the DB&C exercises as per the booklet provided. No further coached respiratory physiotherapy is provided.
To reduce confounding variables no other pre- or post-operative respiratory physiotherapy will be provided.
Control group
Active

Outcomes
Primary outcome [1] 301095 0
% who develop a Post-operative Pulmonary Complication as diagnosed with the following criteria: When four (4) or more of the following criteria are present 1. Chest radiograph (CXR) report of collapse/consolidation. When a CXR has been taken but no report is available, a ward medical officer, or a senior respiratory physiotherapist with more than 10 years' experience will be asked to report. 2. Raised maximum tympanic temperature greater than 38.0 C on more than one consecutive post-operative day 3. Pulse oximetry oxygen saturation (Sp02) less than 90% on room air on more than one consecutive post-operative day 4. Production of yellow or green sputum different to pre-operative 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 pneumonia, lower or upper respiratory tract infection, an undefined chest infection or prescription of an antibiotic for a respiratory infection
Timepoint [1] 301095 0
Daily measure until post-operative day 7 or discharge from hospital whichever occurs first. From day 7 and up until Day 14, if there are any documented reasons i,n the daily medical record that indicate a deterioration in respiratory status a full respiratory complication diagnostic screen using the defined tool will be enacted.
Secondary outcome [1] 331711 0
Pneumonia defined as new CXR infiltrates along with at least two of the following criteria: temp >38 °C, SOB, cough and purulent sputum, altered respiratory auscultation and WCC >12,000/ml or leukopenia <3000/ml, within the first 14 postoperative hospital days or hospital discharge whichever occurs first.
Timepoint [1] 331711 0
Post-operative day 1 to post-operative day 14
Secondary outcome [2] 331712 0
Length of hospital stay in days taken from hospital clinical data management systems
Timepoint [2] 331712 0
Total days in hospital from admission to discharge to a community dwelling
Secondary outcome [3] 331713 0
ICU length of stay taken from hospital clinical data management systems
Timepoint [3] 331713 0
During the acute hospital stay
Secondary outcome [4] 331714 0
Unplanned ICU readmission taken from hospital clinical data management systems
Timepoint [4] 331714 0
Any time during acute hospital stay
Secondary outcome [5] 331716 0
Reintubation rates taken from hospital clinical data management systems
Timepoint [5] 331716 0
Anytime in acute hospital episode
Secondary outcome [6] 331717 0
in-hospital mortality taken from hospital clinical data management systems
Timepoint [6] 331717 0
Anytime in acute hospital episode
Secondary outcome [7] 331718 0
All-cause mortality taken from state and federal government data management systems
Timepoint [7] 331718 0
to 12 months
Secondary outcome [8] 331719 0
Systemic inflammatory response syndrome (SIRS) as defined by 2 or more of the following: temp >38 or <36; HR>90; RR>20, or PCO2<32, or ventilation for acute process; WCC>12 or <4
measured prospectively and daily by a blinded assessor using available information from the medical clinical record
Timepoint [8] 331719 0
Post-operative day 1 to post-operative day 14.
Secondary outcome [9] 331720 0
Sepsis, defined as a Sequential Organ Failure Assessment (SOFA) score greater than or equal to 2
measured prospectively and daily by a blinded assessor using available nformation from the medical clinical record
Timepoint [9] 331720 0
Within 14 postoperative hospital days
Secondary outcome [10] 331877 0
Composite outcome of any one of the following major adverse events directly related to the intervention will be reported and documented including: i. Surgical anastamosis leak. Anastomosis leak suspected and reported by treating surgeon team and confirmed by CT, ii. Severe hypotension requiring increase in medical management, iii. cardiac or respiratory arrest and iv. deterioration in medcial condition requiring an increase in medical management.
Timepoint [10] 331877 0
During, immediately following, and post 30-minutes of BiPAP NIV application
Secondary outcome [11] 331878 0
Feasibility of BiPAP NIV will be reported as any reason resulting in early cessation of therapy.
Timepoint [11] 331878 0
During NIV therapy sessions
Secondary outcome [12] 331879 0
Feasibility of BiPAP NIV will be reported as any reason NIV therapy is unable to be provided to a participant.
Timepoint [12] 331879 0
Within the first 3 postoperative hospital days
Secondary outcome [13] 342608 0
Feasibility of BiPAP NIV will be reported as time to the first BiPAP NIV delivered in hours following post-surgical extubation
Timepoint [13] 342608 0
Within the first three postoperative days
Secondary outcome [14] 342609 0
Feasibility of HFNP will be reported as time to HFNP following extubation from surgery, and duration of HFNP in the first 48 hours following extubation. All reasons for non-delivery of HFNP will be reported.
Timepoint [14] 342609 0
Within the first three postoperative days
Secondary outcome [15] 342610 0
Health Related Quality of Life (HRQoL) using the EQ-5D-5L preoperatively, postoperative day seven, postoperative day fourteen and at 12-months post-surgery.
Timepoint [15] 342610 0
Preoperatively (within six weeks prior to surgery) at the participants pre-admission physiotherapy appointment, postoperative day seven, postoperative day fourteen and at 12-months post surgery.
Secondary outcome [16] 342611 0
Health service costs of HFNP and physiotherapy-led BiPAP NIV service delivery assessed using; the equipment costs involved (including BiPAP NIV and HFNP circuits and BiPAP NIV masks per participant), cleaning and machine service costs assessed from hospital records, costs of the physiotherapy BiPAP NIV service assessed by physiotherapy time attributed to the provision of the BiPAP NIV for the two postoperative days and costs of an ICU bed day and surgical ward day for each participant using medical records. Stays of less than one day in either the ICU or surgical ward will be rounded up to one day.
Timepoint [16] 342611 0
On completion of the participants acute hospital stay (discharge from the hospital or discharge to a rehab facility).
Secondary outcome [17] 342612 0
Transient physiological events directly related to the intervention will be reported and documented including i. hypotension, defined as a decrease in blood pressure >20mmHg determined by pre/post blood pressure observations not requiring medical management ii decrease in Sp02 >10% from baseline or <85% for >60 seconds, iii. uncontrolled vomiting iv. gastric distention as clinically reported by the treating surgeon v. Nasal bridge or facial erythema or ulceration
Timepoint [17] 342612 0
During, immediately following, and within 30-minutes post BiPAP NIV application.
Secondary outcome [18] 342613 0
Feasibility of BiPAP NIV intervention will also be reported as duration of each BiPAP NIV session (in minutes) delivered to participants.
Timepoint [18] 342613 0
Within three postoperative days.
Secondary outcome [19] 342614 0
Feasibility of BiPAP NIV will also be reported as the number of BiPAP NIV sessions delivered to each participant.
Timepoint [19] 342614 0
Within three postoperative days.
Secondary outcome [20] 344788 0
Consent rate and recruitment ability
Timepoint [20] 344788 0
Within the first three postoperative days
Secondary outcome [21] 344789 0
Protocol adherence of physiotherapy-led BiPAP NIV therapy. Successful physiotherapy-led BiPAP NIV is set at equal to or less than 20% protocol deviations. This will be measured by the proportion of intervention participants who receive the first BiPAP NIV session within four hours of surgical-extubation and the proportion of intervention participants who receive five, 30-minute BiPAP NIV sessions in the first two postoperative days
Timepoint [21] 344789 0
Within three postoperative days
Secondary outcome [22] 344790 0
Protocol adherence of HFNP oxygen therapy. Successful HFNP oxygen therapy implementation is set at equal to or less than 20% protocol deviations. This will be measured by the proportion of participants who receive HFNP oxygen therapy for 48 continuous hours following surgical-extubation.
Timepoint [22] 344790 0
Within the first three postoperative days

Eligibility
Key inclusion criteria
Adults having elective open upper abdominal surgery and/or advanced hand-assisted laparoscopic abdominal surgery with a planned postsurgical admission to ICU, or those having elective open upper abdominal surgery and/or advanced hand-assisted laparoscopic abdominal surgery for post-surgical admission to the ward who are screened as being at high risk of a PPC using the Melbourne Risk Prediction Tool (Scholes et al 2007)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under 18 years of age, any absolute contraindications to BiPAP NIV in the period following surgery prior to the first NIV session, requiring oesophagectomy surgery, obstructive sleep apnoea requiring continuous positive airway pressure (CPAP) overnight, extreme claustrophobia and unable to tolerate a NIV facemask, unable to understand verbal instructions in English, do not have capacity to give consent themselves, a current hospital patient for a separate episode of care, requiring organ transplant,

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)
Participants will be randomly allocated at the end of their surgical procedure when their post-surgical destination is confirmed and exclusion criteria assessed using a block design via sequentially numbered opaque envelopes prepared by a statistician and administrated by an independent assistant who will take no further part in the study. Each envelope will contain a card with the allocation group determined by a computer generated block. Randomisation will be stratified to planned postsurgical destination (ICU or WARD).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated at the end of their surgical procedure when their post-surgical destination is confirmed and exclusion criteria assessed using a block design via sequentially numbered opaque envelopes prepared by a statistician and administrated by an independent assistant who will take no further part in the study. Each envelope will contain a card with the allocation group determined by a computer generated block. Randomisation will be stratified to planned postsurgical destination (ICU or WARD).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The prognostic strength and size of imbalances due to potential confounding baseline variables between groups will be assessed. Adjustment covariates will be selected by backward stepwise regression from covariates that may have the potential for clinically significant alterations in effect sizes. These include: history of a respiratory comorbidity, smoking history, age, length in time of operation, operation category (upper gastrointestinal, colorectal, urological, other), incision type and location, intraoperative ventilation strategies, fluid delivery, blood transfusions, and mode of post-operative analgesia.
The primary outcomes of absolute and relative rates of PPC in the trial groups will be estimated using multivariate robust random effects Poisson generalised linear modelling to allow assessment of binary outcomes with or without adjustment for potential confounding variables (incidence rates and rate ratios, 95 % confidence intervals, P-values). In addition, the effect of time from the end of surgery/anaesthesia to diagnosis of PPC will be compared using Cox proportional hazards regression with and without covariate adjustment (hazards ratio, 95 % confidence intervals, P-values). Graphic representation of this analysis will be performed using the Kaplan-Meier method.
A number of secondary outcomes will be treated as time-to-event analyses, with hazard ratios estimated using Cox proportional hazards regression: 1) The day of first diagnosis of other events will be recorded (pneumonia, SIRS, sepsis, reintubation, death); 2) Treatment group comparison for time from surgery to readiness for discharge, and to actual discharge (LOS), will be made using Cox proportional hazards regression, with successful discharge treated as censoring “failure” and death or no discharge within 30 days treated as censoring “non-failure”. Binomial secondary outcomes including unplanned ICU admission, unplanned reintubation will be analysed using mixed effects Poisson regression. Secondary outcomes with irregular distributions, including length of time periods (ICU and total post-operative LOS) and HRQoL, will be evaluated for group differences using mixed effects ordered logistic regression, with mean time (95 % CI) estimated for descriptive purposes using mixed effects linear regression. An intention-to-protocol sensitivity analysis will be performed by excluding from the analysis any participant who did not undergo the planned postoperative NIV intervention treatment. The sensitivity of the outcome estimates to missing data will be evaluated using multiple imputation. All analyses will be performed using Stata version 14 or later (StataCorp, College Station, TX, USA) and analysed on an intention-to-treat basis.

For the trial, there will be a stopping rule for the potential of NIV or high-flow nasal oxygen therapy to be harmful. An unacceptable rate of anastomotic leakage of over 2.5% will trigger consideration for trial termination by the independent DSMB established for the oversight of this clinical trial. To detect a 2.5% anastomotic leakage rate in either group requires a minimum of 57 patients (one-sample test of proportion compared to hypothetical 0.1% rate; power 80%; alpha 0.05). Analysis of anastomotic leakage rates in both groups will therefore be performed at participant recruitment number 60 using cumulative summation analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/02/2017
Actual
23/02/2017
Date of last participant enrolment
Anticipated
23/08/2018
Actual
6/08/2018
Date of last data collection
Anticipated
6/08/2019
Actual
6/08/2019
Sample size
Target
130
Accrual to date
Final
130
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 7490 0
Launceston General Hospital - Launceston
Recruitment postcode(s) [1] 15315 0
7250 - Launceston

Funding & Sponsors
Funding source category [1] 295623 0
Charities/Societies/Foundations
Name [1] 295623 0
Clifford Craig Medical Research Trust
Country [1] 295623 0
Australia
Primary sponsor type
Hospital
Name
Launceston General Hospital
Address
Physiotherapy Department
Launceston General Hospital
PO Box 1963
Launceston, Tasmania, 7250
Country
Australia
Secondary sponsor category [1] 294467 0
None
Name [1] 294467 0
Address [1] 294467 0
Country [1] 294467 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296944 0
Tasmanian Human Ethics Committee
Ethics committee address [1] 296944 0
Office of Research Services
University of Tasmania
Private Bag 1
Hobart, Tasmania, 7001
Ethics committee country [1] 296944 0
Australia
Date submitted for ethics approval [1] 296944 0
29/08/2016
Approval date [1] 296944 0
08/02/2017
Ethics approval number [1] 296944 0
H0016207

Summary
Brief summary
Abdominal surgery is the most common surgery in Australia with over 130,000 operations annually. Complications are unfortunately common following upper abdominal surgery (UAS) and the most common type of complication is a post-operative pulmonary complication (PPC) with a reported incidence of up to 60% depending on the underlying risk characteristics of the patient and the surgery type. The leading cause of in-hospital death following UAS during is sepsis with a primary infective source of pneumonia.
Preventing PPC is a key component of physiotherapy practice. Systematic reviews support the use of non-invasive ventilation (NIV) to prevent respiratory complications following abdominal surgery. NIV may reduce PPC risk by half, with a further sub-group effect specifically preventing pneumonia. Mechanically driven air-flow is delivered during inspiration via a sealed facemask or nasal interface until a predetermined positive airway pressure is obtained. This positive lung pressure increases lung volumes, reverses airway collapse, and improves gas exchange following abdominal surgery. Despite evidence supporting NIV, uptake in hospitals is poor and is utilised in just 3% of patients.
If NIV has been shown to be superior to usual care in the prevention of PPC following abdominal surgery, why is it that this therapy is not widely provided as standard care? It could be because the perceived risk/negatives outweigh the benefit and the requirement for a dedicated skilled health professional to apply, titrate, and to monitor the use of NIV outside ICU. Unfortunately, this is conjecture as there is a paucity of cost-benefit and risk analysis evidence for NIV and requires investigating in detail.
High flow nasal prongs (HFNP) have recently replaced standard oxygen therapy as standard care for surgical patients admitted to ICU. HFNP deliver heated and humidified gas flow via nasal prongs at a prescribed amount of oxygen with an increased flow of air which can provide a constant low level of positive airway pressure. HFNP may increase lung volumes and recruit collapsed alveoli. it is possible that HFNP could be a viable prophylactic modality preventing PPC and may be a more feasible option compared to NIV. This remains unproven as all NIV clinical trials investigating its prophylactic properties have only compared it to standard oxygen therapy. This trial aims to detect whether there is a possible signal towards reduction in PPC with the use of intermittent NIV in addition to continuous HFNP oxygen therapy following high-risk elective UAS and to measure the feasibility of providing these interventions. These findings will assist in designing and conducting future multi-centre trials.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72502 0
Ms Ianthe Boden
Address 72502 0
Physiotherapy Department
Launceston General Hospital
PO Box 1963
Launceston, Tasmania 7250
Country 72502 0
Australia
Phone 72502 0
+61 3 6777 6216
Fax 72502 0
Email 72502 0
ianthe.boden@ths.tas.gov.au
Contact person for public queries
Name 72503 0
Ms Ianthe Boden
Address 72503 0
Physiotherapy Department
Launceston General Hospital
PO Box 1963
Launceston, Tasmania 7250
Country 72503 0
Australia
Phone 72503 0
+61 3 6777 6216
Fax 72503 0
Email 72503 0
ianthe.boden@ths.tas.gov.au
Contact person for scientific queries
Name 72504 0
Ms Ianthe Boden
Address 72504 0
Physiotherapy Department
Launceston General Hospital
PO Box 1963
Launceston, Tasmania 7250
Country 72504 0
Australia
Phone 72504 0
+61 3 6777 6216
Fax 72504 0
Email 72504 0
ianthe.boden@ths.tas.gov.au

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/instutional review board clearance to share deidentified data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1594Study protocol    http://dx.doi.org/10.1136/bmjopen-2018-023139 372361-(Uploaded-12-03-2019-10-48-08)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseNon-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.2019https://dx.doi.org/10.1136/bmjopen-2018-023139
EmbaseNon-Invasive Positive airway Pressure thErapy to Reduce Postoperative Lung complications following Upper abdominal Surgery (NIPPER PLUS): a pilot randomised control trial.2022https://dx.doi.org/10.1016/j.physio.2022.06.001
N.B. These documents automatically identified may not have been verified by the study sponsor.