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

ISRCTN	ISRCTN30832694
DOI	https://doi.org/10.1186/ISRCTN30832694
Protocol serial number	N0557168271
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funder	The Dudley Group of Hospitals NHS Trust (UK), NHS R&D Support Funding

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(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
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	31/07/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Russells Hall Hospital

Dudley
DY1 2HQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.