|
ISRCTN
|
ISRCTN30832694
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Does the incentive spirometer decrease post operative pulmonary complications and shorten hospital stay? A randomised controlled trial
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0557168271
|
|
Study hypothesis
|
Does incentive spirometry in addition to standard physiotherapy decrease the incidence of post operative pulmonary complications and shorten length of stay on High Dependency and total length of stay in hospital compared with traditional physiotherapy offered to post operative patients who have undergone major abdominal surgery?
|
|
Lay summary
|
|
|
Ethics approval
|
Added 08/09/08: Dudley Local Ethics Committee (UK), 03/08/2005, REC ref 05/Q2702/30.
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Surgery: Abdominal
|
|
Participants - inclusion criteria
|
All patients on surgical high dependency ward following abdominal surgery and able to understand and use the incentive spirometer.
|
|
Participants - exclusion criteria
|
Patients who cannot understand and use the incentive spiromenter.
|
|
Anticipated start date
|
11/08/2005
|
|
Anticipated end date
|
31/07/2009
|
|
Status of trial
|
Completed |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
360
|
|
Interventions
|
360 patients undergoing major abdominal surgery, randomised to:
1. Traditional physiotherapy (180 patients)
2. Use of incentive spirometer and traditional physiotherapy (180 patients)
|
|
Primary outcome measure(s)
|
1. Length of stay on the High Dependency Unit
2. Length of hospital stay
3. Post operative pulmonary complications as judged by predefined criteria
4. Standard physiological observations
5. Antibiotic usage and indication for use
6. Chest x-ray findings
7. Number of physiotherapy contacts and time spent with each patient
|
|
Secondary outcome measure(s)
|
No secondary outcome measures
|
|
Sources of funding
|
The Dudley Group of Hospitals NHS Trust (UK), NHS R&D Support Funding
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Mr
Khong
Yoong
|
|
Address
|
Consultant General Surgeon
Surgical Offices, 1st Floor, West Wing
Russells Hall Hospital
|
|
City/town
|
Dudley
|
|
Zip/Postcode
|
DY1 2HQ
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 01384 244163
|
|
Fax
|
+44 01384 244156
|
|
Email
|
Kirsty.Westwood@dgoh.nhs.uk
|
|
Sponsor
|
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
|
|
Address
|
The Department of Health, Richmond House, 79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/Home/fs/en
|
|
Date applied
|
29/09/2006
|
|
Last edited
|
05/09/2008
|
|
Date ISRCTN assigned
|
29/09/2006
|
