Leakage of fluid around the bronchial cuffs of double lumen endobronchial tubes (DLEBT)
| ISRCTN | ISRCTN55322156 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55322156 |
| Secondary identifying numbers | N0054131773 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 07/01/2009
- 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
Dr P Sanjay
Scientific
Scientific
Department of Anaesthesia
The Cardiothoracic Centre
Liverpool NHS Trust
Thomas Drive
Liverpool
L14 3PE
United Kingdom
| Phone | +44 (0)151 228 1616 |
|---|
Study information
| Study design | Prospective randomised double blind trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | To determine the incidence of fluid leakage past the bronchial cuff of double lumen endobronchial tubes and to investigate the effectiveness of gel lubrication in reducing fluid leakage past the bronchial cuff. Demonstration by fibreoptic bronchoscopy of dye leakage past the bronchial cuff of double lumen endobronchial tubes placed in patients undergoing right sided thoracic procedure in the lateral position. An aspiration rate of 44% has been shown in patients receiving unlubricated double lumen endobronchial tubes. We consider a clinically important reduction would be a reduction of 50%. Assuming a baseline aspiration rate of 44%, a sample size of 55 per group will provide a study of 80% power to detect this difference with a 5% chance of error (one tailed). 55 patients per group, plus 5 per group to allow for data corruption i.e. (55+5) x 2 = 120 patients in total. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Thoracic |
| Intervention | Adult patients scheduled to undergo a right thoracic procedure involving lung isolation will be randomly assigned to one of two groups. One group will receive an unlubricated DLEBT and the other group will receive a DLEBT liberally lubricated with aqueous jelly. A left sided DLEBT will be used for a right sided procedure. After placing the patients in a lateral position and confirming correct placement of the DLEBT with a fibreoptic bronchoscope, both groups will receive 10 mg (1 ml) of methylthionium chloride (methylene blue) made up to 5 ml with normal saline placed above the bronchial cuff via an epidural catheter. At 30-minute intervals during the procedure and immediately prior to extubation, the endobronchial lumen will be aspirated and the aspirates examined by a blinded observer for staining. The same observer will then utilise a fibreoptic bronchoscope to examine the bronchial mucosa for blue staining. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Some patients develop acute respiratory distress syndrome (ARDS) after an uneventful pneumonectomy a condition termed post-pneumonectomy syndrome. The pathogenesis of this syndrome is poorly understood. An increase in hydrostatic pressure after lung removal is unlikely to be the sole cause in the majority of patients. Aspiration of infected material or gastric acid past the endobronchial cuff of an endobronchial tube may be a significant factor in the development of this syndrome. This study will demonstrate by fibreoptic bronchoscopy of dye leakage past the bronchial cuff of double lumen endobronchial tubes placed in patients undergoing right sided thoracic procedure in the lateral position. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/11/2003 |
| Completion date | 31/05/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 55 patients per group, plus 5 per group to allow for data corruption i.e. (55+5) x 2 = 120 patients in total. |
| Key inclusion criteria | Adult patients undergoing thoracotomy or thoracoscopy. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/11/2003 |
| Date of final enrolment | 31/05/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Anaesthesia
Liverpool
L14 3PE
United Kingdom
L14 3PE
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
Government
The Cardiothoracic Centre Liverpool NHS Trust (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 | 01/02/2006 | Yes | No |
