Leakage of fluid around the bronchial cuffs of double lumen endobronchial tubes (DLEBT)

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN55322156
• Date of registration: 30/09/2004
• Prospective Registration: No
• Primary sponsor: Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
• Public title: Leakage of fluid around the bronchial cuffs of double lumen endobronchial tubes (DLEBT)
• Date of first enrolment: 01/11/2003
• Target sample size: 120
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN55322156
• Study type: Interventional
• Study design: Prospective randomised double blind trial (Not Specified)

Countries of recruitment

United Kingdom

Contacts

• Name: P Sanjay

Key inclusion & exclusion criteria

Inclusion criteria: Adult patients undergoing thoracotomy or thoracoscopy.
Exclusion criteria: Not provided at time of registration

Age minimum:
Age maximum:
Gender: Not Specified

Health Condition(s) or Problem(s) studied

Surgery: Thoracic
Surgery
Thoracic

Intervention(s)

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.

Primary Outcome(s)

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(s)

Not provided at time of registration

Secondary ID(s)

N0054131773

Source(s) of Monetary Support

The Cardiothoracic Centre Liverpool NHS Trust (UK)