Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0054128023
Study information
Scientific title
Acronym
Study hypothesis
A Randomised Controlled Trial to investigate tracheal reflux in the early postoperative period. Can acid reflux be reduced by the oral administration of a Proton Pump Inhibitor?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Surgery: Thoracotomy
Intervention
A Prospective Randomised Double Blind Controlled Trial to investigate tracheal reflux in the early post-operative period. Consenting patients who are presenting for Thoracotomy for Lung resection under the care of two Thoracic surgeons. Patients after completion of surgery but prior to reversal of general anaesthetic, will have a 1.5 mm antimony pH probe inserted percutaneously under brochoscopic control into the trachea via the cricothyroid membrane. The device will then record and store pH every 5 seconds for the first 48 hour post-operatively, The data will be analysed for number and duration of aspiration episodes.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Study end points will be:
1. The number of episodes per hour as defined by a reversible decrease in pH to less than 6.5 and lasting at least 1 min
2. The fractional (%) time the pH is less than 6.5
3. The number of aspiration episodes lasting more than 5 min
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/06/2003
Overall trial end date
31/12/2003
Reason abandoned
Eligibility
Participant inclusion criteria
50 patients undergoing thoracotomy
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
50
Participant exclusion criteria
1. Patients who have thyroid goitre or pathology making thyrocricoid puncture difficult
2. Patients with a history of gastro-oesophageal reflux disease (GORD), Hiatus hernia or currently taking proton pump inhibitor (PPI)/antacid
Recruitment start date
01/06/2003
Recruitment end date
31/12/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Cardiac Surgery
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
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16521172
Publication citations
-
Results
Shackcloth MJ, McCarron E, Kendall J, Russell GN, Pennefather SH, Tran J, Page RD, Randomized clinical trial to determine the effect of nasogastric drainage on tracheal acid aspiration following oesophagectomy., Br J Surg, 2006, 93, 5, 547-552, doi: 10.1002/bjs.5284.