|
ISRCTN
|
ISRCTN88216651
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
A Prospective descriptive Pilot Trial to investigate tracheal reflux in the early post-operative period in patients undergoing thoracotomy for lung resection.
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0054128023
|
|
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
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Surgery: Thoracotomy
|
|
Participants - inclusion criteria
|
50 patients undergoing Thoracotomy.
Patients who have thyroid goitre or pathology making thyrocricoid puncture difficult will be excluded. Patients with a history of gastro-oesophageal reflux disease (GORD), Hiatus hernia or currently taking proton pump inhibitor (PPI)/antacid will also be excluded.
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
01/06/2003
|
|
Anticipated end date
|
31/12/2003
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
50
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
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 measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
The Cardiothoracic Centre Liverpool NHS Trust
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
E
McCarron
|
|
Address
|
Department of Cardiac Surgery
The Cardiothoracic Centre
Liverpool NHS Trust
Thomas Drive
|
|
City/town
|
Liverpool
|
|
Zip/Postcode
|
L14 3PE
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)151 228 1616
|
|
Fax
|
+44 (0)151 228 8573
|
|
Email
|
|
|
Sponsor
|
Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
|
|
Address
|
The Department of Health, Richmond House, 79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/Home/fs/en
|
|
Date applied
|
30/09/2004
|
|
Last edited
|
22/12/2005
|
|
Date ISRCTN assigned
|
30/09/2004
|
