Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
15/01/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr E McCarron

ORCID ID

Contact details

Department of Cardiac Surgery
The Cardiothoracic Centre
Liverpool NHS Trust
Thomas Drive
Liverpool
L14 3PE
United Kingdom
+44 (0)151 228 1616

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

http://www.dh.gov.uk/Home/fs/en

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

  1. 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.

Additional files

Editorial Notes