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
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