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

ISRCTN	ISRCTN25577630
DOI	https://doi.org/10.1186/ISRCTN25577630
Protocol serial number	N0116135566
Sponsor	Department of Health
Funder	Kings College Hospital NHS Trust R&D Consortium (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr LCH John
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Does continued ventilation during cardiopulmonary bypass reduce lung complications following cardiac surgery?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	1. intubation time 2. duration of inpatient stay 3. incidence of chest complications
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/08/2004

Participant type(s)	Patient
Age group	Other
Sex	Male
Target sample size at registration	23
Key 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
Key exclusion criteria	1. insulin dependent diabetes 2. history of lung disease
Date of first enrolment	01/09/2003
Date of final enrolment	01/08/2004

Cardiothoracic Surgery

London
SE5 9RS
United Kingdom

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2008		Yes	No