A Prospective descriptive Pilot Trial to investigate tracheal reflux in the early post-operative period in patients undergoing thoracotomy for lung resection.
| ISRCTN | ISRCTN88216651 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88216651 |
| Secondary identifying numbers | N0054128023 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 15/01/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr E McCarron
Scientific
Scientific
Department of Cardiac Surgery
The Cardiothoracic Centre
Liverpool NHS Trust
Thomas Drive
Liverpool
L14 3PE
United Kingdom
| Phone | +44 (0)151 228 1616 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/06/2003 |
| Completion date | 31/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 50 |
| Key inclusion criteria | 50 patients undergoing thoracotomy |
| Key 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 |
| Date of first enrolment | 01/06/2003 |
| Date of final enrolment | 31/12/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Cardiac Surgery
Liverpool
L14 3PE
United Kingdom
L14 3PE
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
The Cardiothoracic Centre Liverpool NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2006 | Yes | No |
