Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
07/01/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr P Sanjay

ORCID ID

Contact details

Department of Anaesthesia
The Cardiothoracic Centre
Liverpool NHS Trust
Thomas Drive
Liverpool
L14 3PE
United Kingdom
+44 (0)151 228 1616

Additional identifiers

EudraCT 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

Not provided at time of registration

Study design

Prospective randomised double blind trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial 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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/11/2003

Overall trial end date

31/05/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Adult patients undergoing thoracotomy or thoracoscopy.

Participant type

Patient

Age group

Adult

Gender

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

United Kingdom

Trial 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

http://www.dh.gov.uk/Home/fs/en

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16430565

Publication citations

  1. Results

    Sanjay PS, Miller SA, Corry PR, Russell GN, Pennefather SH, The effect of gel lubrication on cuff leakage of double lumen tubes during thoracic surgery., Anaesthesia, 2006, 61, 2, 133-137, doi: 10.1111/j.1365-2044.2005.04440.x.

Additional files

Editorial Notes