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Trial registered on ANZCTR


Registration number
Ethics application status
Yes
Date submitted
11/06/2013
Date registered
Date last updated

Titles & IDs
Public title
LIPPSMAck POP trial - Lung Infection Prevention Post Surgery (Major Abdominal) with Pre-Operative Physiotherapy education.
Scientific title
For adults awaiting major elective upper abdominal surgery, does face to face pre-operative education from a Physiotherapist reduce their risk of getting a post-operative pulmonary complication, compared to receiving an information booklet alone?
Secondary ID [1] 282652 0
Nil
Universal Trial Number (UTN)
U1111-1144-2282
Trial acronym
LIPPSMAck POP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative pulmonary complications 289354 0
Condition category
Condition code
Surgery 289689 289689 0 0
Other surgery
Physical Medicine / Rehabilitation 289690 289690 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One (1) 30-45 minute face to face pre-operative education session delivered by a Physiotherapist within 6 weeks of the schedued operation date. Each session will consist of education on the prevention of post-operative pulmonary complications stressing the importance of early post-operative ambulation and self-directed deep breathing and coughing (DB&C) exercises. 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 only and assist them out of bed to walk as far as possible on that day. 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. The patients will also have practice on how to sit over the edge of the bed by themselves in preparation for this activity post-operatively when they have a large abdominal wound.
During the pre-operative education session the patients will have supervised practice of DB&C exercises of 2 sets of 10 slow deep breaths to maximum capacity with each deep breath ending with a 3 to 5 second breath hold. A cough, or huff, 3 times in a row is to follow after each set of 10 breaths. The patient will be introduced to the use of a “cough pillow” and educated on its role to support the abdominal wound following surgery and to use it during each cough or huff to encourage greater expiratory force. They will be encouraged to practice these exercises prior to their surgical procedure at least twice a day to develop familiarity. They will be instructed to perform these DB&C exercises following their operation every hour during daytime waking hours especially focusing on the 1st to 3rd post-operative day.
Each patient in the intervention group will be given a rough 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.
Intervention code [1] 287318 0
Prevention
Comparator / control treatment
Provision of an education booklet (indentical to the intervention group) outlining prevention of post-operative pulmonary complications, 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.
Control group
Placebo

Outcomes
Primary outcome [1] 289784 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
• Chest radiograph report of collapse/consolidation
• Raised maximum tympanic temperature >38C on more than one consecutive post-operative day
• Pulse oximetry oxygen saturation (Sp02) <90% on room air on more than one consecutive post-operative day
• Production of yellow or green sputum different to pre-operative assessment
• Presence of infection on sputum culture report
• An otherwise unexplained white cell count greater than 11 OR prescription of an antibiotic specific for respiratory infection
• New abnormal breath sounds on auscultation different to preoperative assessment
• Physician’s diagnosis of postoperative pulmonary complication
Timepoint [1] 289784 0
Daily measure
Secondary outcome [1] 303232 0
Length of hospital stay in days
Timepoint [1] 303232 0
Daily

Eligibility
Key inclusion criteria
All patients awaiting elective major upper abdominal surgery at the Launceston General Hospital, Tasmania. UAS is defined as any type of open incision above the umbilicus.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pre-existing condition that would limit their ability to participate in the standardised mobilisation protocol post-operatively. This is defined as any person who is unable to stand upright and ambulate for a maximum of 6 minutes without a seated rest. eg paraplegics, hoist transfer nursing home and disability patients, severely cognitively disabled patients who would not reliably participate in the post-operative ambulation program.
- Unable to understand verbal or written instructions in English
- Unable to attend a pre-admission assessment and education session with a Physiotherapist.

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)
Eligible patients who are listed for elective major upper abdominal surgery will be identified from the hospital's elective gastrointestinal, urology, and general surgery waiting lists. Written information about the clinical trial and consent form will be sent to the patient in the mail. The information and consent form will be re-presented to patient, or next of kin, at presentation to hospital for their pre-admission appointment.
Allocation: Patients will be randomly allocated by the Pre-operative Physiotherapist by opening a pre-prepared sealed opaque envelope containing a card with the nominated group allocation . After allocation patient details will be written on envelope once opened to ensure that patients were randomised in the same order as they were recruited.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An administration assistant (who then takes no further part in the study) will prepare sequentially numbered opaque envelopes, each containing a card with allocation group determined by computer generated random number (odd=intervention).
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
Recent published Australian studies (Scholes 2009, Browning 2007) in this patient population have measured the rate of post-operative pulmonary complications at 15-20% in context of providing pre-operative physiotherapy education and a once only post-operative physiotherapy session.
To measure a significant difference between groups it is calculated that a total sample size of 377 is required given an overall 20% PPC rate and a clinically effective reduction of this rate to be 10%, and calculating for a 20% dropout rate. This is calculated using Inference for Proportions: Comparing Two Independent Samples (Alpha 0.05, Beta 80%, 1 sided test)

The effectiveness of the randomisation process will be tested by single logistic regression for categorical variables; general linear modelling for normally distributed continuous data, and ordinal logistic regression for non-normal continuous data.
The rate of PPC in the trial groups will be compared using a multivariate logistic regression (to allow assessment of binary outcomes without or with adjustment for potential confounding variables). LOS will be compared using ordinal logistic regression to determine differences at the individual level; and mean and 95% CI will be estimated for the group differences using mixed methods linear regression with bootstrap estimates of asymmetric confidence intervals. Alpha will be set at 0.05

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2013
Actual
Date of last participant enrolment
Anticipated
31/07/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
377
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS,VIC
Recruitment hospital [1] 1118 0
Launceston General Hospital - Launceston
Recruitment hospital [2] 1119 0
Western Hospital - Footscray
Recruitment postcode(s) [1] 6956 0
7250 - Launceston
Recruitment postcode(s) [2] 6957 0
3011 - Footscray

Funding & Sponsors
Funding source category [1] 287436 0
Charities/Societies/Foundations
Name [1] 287436 0
Clifford Craig Medical Research Trust
Country [1] 287436 0
Australia
Primary sponsor type
Individual
Name
Ianthe Boden
Address
Physiotherapy Department
Launceston General Hospital
Charles St
Launceston, Tasmania, 7250
Country
Australia
Secondary sponsor category [1] 286179 0
None
Name [1] 286179 0
Address [1] 286179 0
Country [1] 286179 0
Other collaborator category [1] 277448 0
University
Name [1] 277448 0
Department of Physiotherapy
Melbourne School of Health Sciences
The University of Melbourne
Address [1] 277448 0
Physiotherapy
Melbourne School of Health Sciences
The University of Melbourne
Alan Gilbert Building
161 Barry Street, Carlton
Victoria 3053
Country [1] 277448 0
Australia

Ethics approval
Ethics application status
Yes
Ethics committee name [1] 289412 0
Human Research Ethics committee (Tasmania) network
Ethics committee address [1] 289412 0
Ethics committee country [1] 289412 0
Australia
Date submitted for ethics approval [1] 289412 0
Approval date [1] 289412 0
06/09/2011
Ethics approval number [1] 289412 0
H0011911

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40666 0
Ms Ianthe Boden
Address 40666 0
Physiotherapy Department
Launceston General Hospital
Launceston, Tasmania
Country 40666 0
Australia
Phone 40666 0
+61, 3, 6348 7216
Fax 40666 0
Email 40666 0
ianthe.boden@dhhs.tas.gov.au
Contact person for public queries
Name 40667 0
Ianthe Boden
Address 40667 0
Physiotherapy Department
Launceston General Hospital
Launceston, Tasmania
Country 40667 0
Australia
Phone 40667 0
+61 3 63487216
Fax 40667 0
Email 40667 0
ianthe.boden@dhhs.tas.gov.au
Contact person for scientific queries
Name 40668 0
Ianthe Boden
Address 40668 0
Physiotherapy Department
Launceston General Hospital
Launceston, Tasmania
Country 40668 0
Australia
Phone 40668 0
+61 3 63487216
Fax 40668 0
Email 40668 0
ianthe.boden@dhhs.tas.gov.au

No information has been provided regarding IPD availability


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
No additional documents have been identified.