Would continued ventilation during cardiopulmonary bypass reduce lung complications following cardiac surgery?
| ISRCTN | ISRCTN25577630 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25577630 |
| Secondary identifying numbers | N0116135566 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 21/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr LCH John
Scientific
Scientific
Cardiothoracic Surgery
King's College Hospital
London
SE5 9RS
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 1. intubation time 2. duration of inpatient stay 3. incidence of chest complications |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/2003 |
| Completion date | 01/08/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Male |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cardiothoracic Surgery
London
SE5 9RS
United Kingdom
SE5 9RS
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Other
Kings College Hospital NHS Trust R&D Consortium (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2008 | Yes | No |
