Does the incentive spirometer decrease post-operative pulmonary complications and shorten hospital stay?

ISRCTN	ISRCTN30832694
DOI	https://doi.org/10.1186/ISRCTN30832694
Secondary identifying numbers	N0557168271

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 27/04/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Khong Yoong
Scientific

Consultant General Surgeon
Surgical Offices, 1st Floor, West Wing
Russells Hall Hospital
Dudley
DY1 2HQ
United Kingdom

Phone	+44 (0)1384 244163
Email	Kirsty.Westwood@dgoh.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Does the incentive spirometer decrease post-operative pulmonary complications and shorten hospital stay? A randomised controlled trial
Study objectives	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?
Ethics approval(s)	Dudley Local Ethics Committee (UK), 03/08/2005, REC ref: 05/Q2702/30.
Health condition(s) or problem(s) studied	Surgery: Abdominal
Intervention	360 patients undergoing major abdominal surgery, randomised to: 1. Traditional physiotherapy (180 patients) 2. Use of incentive spirometer and traditional physiotherapy (180 patients)
Intervention type	Procedure/Surgery
Primary outcome measure	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 measures	No secondary outcome measures
Overall study start date	11/08/2005
Completion date	31/07/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	360
Key inclusion criteria	All patients on surgical high dependency ward following abdominal surgery and able to understand and use the incentive spirometer
Key exclusion criteria	Patients who cannot understand and use the incentive spiromenter
Date of first enrolment	11/08/2005
Date of final enrolment	31/07/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Russells Hall Hospital

Dudley
DY1 2HQ
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

The Dudley Group of Hospitals NHS Trust (UK), NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

27/04/2018: No publications found, verifying study status with principal investigator.
22/03/2016: No publications found, verifying study status with principal investigator.