| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN88216651 |
| Date ISRCTN assigned | 30/09/2004 |
| Local reference number(s) | N0054128023 |
| 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 |
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| Acronym | N/A |
| Disease/condition/study domain | Surgery: Thoracotomy |
| 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? |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| 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 |
| Patient information material |
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| Anticipated start date | 01/06/2003 |
| Anticipated end date | 31/12/2003 |
| Status of trial | Completed |
| 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 |
| Sponsor name | Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK) |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr E McCarron |
| Contact details | Department of Cardiac Surgery
The Cardiothoracic Centre
Liverpool NHS Trust
Thomas Drive
Liverpool
United Kingdom
L14 3PE |
| Contact telephone | +44 (0)151 228 1616 |
| Contact fax | +44 (0)151 228 8573 |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN88216651 |
| Date last extracted from ISRCTN register | 17/04/2008 |
