Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
21/07/2009
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 LCH John

ORCID ID

Contact details

Cardiothoracic Surgery
King's College Hospital
London
SE5 9RS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0116135566

Study information

Scientific title

Acronym

Study hypothesis

Does continued ventilation during cardiopulmonary bypass reduce lung complications following cardiac surgery?

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

Surgery: Cardiovascular

Intervention

In order to answer the research question above the study has the following specific research aims. For selected patients undergoing cardiac surgery and randomised into either a group that is ventilated on bypass or a group that is not, to measure and compare between the two groups:

1. Pulmonary gas exchange
2. Lung mechanics
3. The activation of "inflammatory" pathways within the lungs
4. The presence of increased pulmonary vascular endothelial permeability
5. The presence of other evidence for pulmonary vascular endothelial damage or lung epithelial injury

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

1. intubation time
2. duration of inpatient stay
3. incidence of chest complications

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2003

Overall trial end date

01/08/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. male
2. aged between 50-75 years
3. normal or mildly impaired left ventricular function and no significant elevation of pulmonary artery pressure on preoperative echocardiogram
4. body mass index <30

Participant type

Patient

Age group

Other

Gender

Male

Target number of participants

23

Participant exclusion criteria

1. insulin dependent diabetes
2. history of lung disease

Recruitment start date

01/09/2003

Recruitment end date

01/08/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cardiothoracic Surgery
London
SE5 9RS
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Other

Funder name

Kings College Hospital NHS Trust R&D Consortium (UK)

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

2008 results in http://www.ncbi.nlm.nih.gov//pubmed/17933836

Publication citations

Additional files

Editorial Notes