Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N0054131773
Study information
Scientific title
Acronym
Study hypothesis
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
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
Patient information sheet
Condition
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
Overall study end date
31/05/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Adult patients undergoing thoracotomy or thoracoscopy.
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.
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/11/2003
Recruitment end date
31/05/2004
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Department of Anaesthesia
Liverpool
L14 3PE
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
Government
Funder name
The Cardiothoracic Centre Liverpool NHS Trust (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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2006 | Yes | No |