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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

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]

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

Condition category

Condition code

Surgery

Other surgery

Anaesthesiology

Other anaesthesiology

Respiratory

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]

Treatment: Devices

Intervention code [2]

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]

% 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]

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]

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]

Post-operative day 1 to post-operative day 14

Secondary outcome [2]

Length of hospital stay in days taken from hospital clinical data management systems

Timepoint [2]

Total days in hospital from admission to discharge to a community dwelling

Secondary outcome [3]

ICU length of stay taken from hospital clinical data management systems

Timepoint [3]

During the acute hospital stay

Secondary outcome [4]

Unplanned ICU readmission taken from hospital clinical data management systems

Timepoint [4]

Any time during acute hospital stay

Secondary outcome [5]

Reintubation rates taken from hospital clinical data management systems

Timepoint [5]

Anytime in acute hospital episode

Secondary outcome [6]

in-hospital mortality taken from hospital clinical data management systems

Timepoint [6]

Anytime in acute hospital episode

Secondary outcome [7]

All-cause mortality taken from state and federal government data management systems

Timepoint [7]

to 12 months

Secondary outcome [8]

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]

Post-operative day 1 to post-operative day 14.

Secondary outcome [9]

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]

Within 14 postoperative hospital days

Secondary outcome [10]

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]

During, immediately following, and post 30-minutes of BiPAP NIV application

Secondary outcome [11]

Feasibility of BiPAP NIV will be reported as any reason resulting in early cessation of therapy.

Timepoint [11]

During NIV therapy sessions

Secondary outcome [12]

Feasibility of BiPAP NIV will be reported as any reason NIV therapy is unable to be provided to a participant.

Timepoint [12]

Within the first 3 postoperative hospital days

Secondary outcome [13]

Feasibility of BiPAP NIV will be reported as time to the first BiPAP NIV delivered in hours following post-surgical extubation

Timepoint [13]

Within the first three postoperative days

Secondary outcome [14]

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]

Within the first three postoperative days

Secondary outcome [15]

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]

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]

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]

On completion of the participants acute hospital stay (discharge from the hospital or discharge to a rehab facility).

Secondary outcome [17]

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]

During, immediately following, and within 30-minutes post BiPAP NIV application.

Secondary outcome [18]

Feasibility of BiPAP NIV intervention will also be reported as duration of each BiPAP NIV session (in minutes) delivered to participants.

Timepoint [18]

Within three postoperative days.

Secondary outcome [19]

Feasibility of BiPAP NIV will also be reported as the number of BiPAP NIV sessions delivered to each participant.

Timepoint [19]

Within three postoperative days.

Secondary outcome [20]

Consent rate and recruitment ability

Timepoint [20]

Within the first three postoperative days

Secondary outcome [21]

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]

Within three postoperative days

Secondary outcome [22]

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]

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?

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)

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]

Launceston General Hospital - Launceston

Recruitment postcode(s) [1]

7250 - Launceston

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Clifford Craig Medical Research Trust

Address [1]

W.D. Booth Centre
5th Floor
Launceston General Hospital
274-280 Charles Street
Launceston Tas 7250

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Tasmanian Human Ethics Committee

Ethics committee address [1]

Office of Research Services
University of Tasmania
Private Bag 1
Hobart, Tasmania, 7001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/08/2016

Approval date [1]

08/02/2017

Ethics approval number [1]

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

Ms Ianthe Boden

Address

Physiotherapy Department
Launceston General Hospital
PO Box 1963
Launceston, Tasmania 7250

Country

Australia

Phone

+61 3 6777 6216

Fax

[email protected]

Contact person for public queries

Name

Ianthe Boden

Address

Physiotherapy Department
Launceston General Hospital
PO Box 1963
Launceston, Tasmania 7250

Country

Australia

Phone

+61 3 6777 6216

Fax

[email protected]

Contact person for scientific queries

Name

Ianthe Boden

Address

Physiotherapy Department
Launceston General Hospital
PO Box 1963
Launceston, Tasmania 7250

Country

Australia

Phone

+61 3 6777 6216

Fax

[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/instutional review board clearance to share deidentified data.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1594	Study 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

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Documents added automatically

Source	Title	Year of Publication	DOI
Embase	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.	2019	https://dx.doi.org/10.1136/bmjopen-2018-023139
Embase	Non-Invasive Positive airway Pressure thErapy to Reduce Postoperative Lung complications following Upper abdominal Surgery (NIPPER PLUS): a pilot randomised control trial.	2022	https://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.

Trial Review

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