Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
22/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Khong Yoong

ORCID ID

Contact details

Consultant General Surgeon
Surgical Offices
1st Floor
West Wing
Russells Hall Hospital
Dudley
DY1 2HQ
United Kingdom
+44 (0)1384 244163
Kirsty.Westwood@dgoh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0557168271

Study information

Scientific title

Does the incentive spirometer decrease post-operative pulmonary complications and shorten hospital stay? A randomised controlled trial

Acronym

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?

Ethics approval

Dudley Local Ethics Committee (UK), 03/08/2005, REC ref: 05/Q2702/30.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

11/08/2005

Overall trial end date

31/07/2009

Reason abandoned

Eligibility

Participant inclusion criteria

All patients on surgical high dependency ward following abdominal surgery and able to understand and use the incentive spirometer.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

360

Participant exclusion criteria

Patients who cannot understand and use the incentive spiromenter

Recruitment start date

11/08/2005

Recruitment end date

31/07/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Russells Hall Hospital
Dudley
DY1 2HQ
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

22/03/2016: No publications found, verifying study status with principal investigator