Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
20/08/2012
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

Dr NGPB Batchelor

ORCID ID

Contact details

Anaesthetic Dept
Jubilee Wing
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 (0)113 3926554

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436146556

Study information

Scientific title

Acronym

Study hypothesis

Using alveolar recruitment strategies in the immediate post operative period following cardiopulmonary bypass improves lung function as displayed by an increase in arterial oxygenation. This may therefore reduce post operative complications. i.e pneumonia and reduce time sedated on intensive care.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cardiopulmonary bypass surgery

Intervention

Randomised controlled trial

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

To increase arterial oxygenation

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/12/2003

Overall trial end date

01/06/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Elective coronary artery bypass and uncomplicated aortic root surgery through a median sternotomy

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

28 patients in each arm of the study

Participant exclusion criteria

Patient refusal, pre-existing lung disease, mitral valve disease, known pulmonary hypertension, chronic renal failure, morbid obesity or emergency surgery.

Recruitment start date

01/12/2003

Recruitment end date

01/06/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Anaesthetic Dept
Leeds
LS1 3EX
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

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

Leeds Teaching Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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