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
Protocol serial number	N0054128023
Sponsor	Department of Health
Funder	The Cardiothoracic Centre Liverpool NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr E McCarron
Scientific

Department of Cardiac Surgery
The Cardiothoracic Centre
Liverpool NHS Trust
Thomas Drive
Liverpool
L14 3PE
United Kingdom

Phone	+44 (0)151 228 1616

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2003

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	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

Department of Cardiac Surgery

Liverpool
L14 3PE
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2006		Yes	No