Clinical Trials Directory

Trials / Completed

CompletedNCT01095861

Comparison of Parker Flex-Tip Endotracheal Tube to Standard Endotracheal Tube

Comparison of Parker Flex-Tip Endotracheal Tube to Standard Endotracheal Tube: A Randomized Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
200 (actual)
Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

Summary

Patients presenting for elective surgery requiring tracheal intubation will be randomized to one of two different endotracheal tubes (ETT).

Detailed description

The post-operative complication of a sore throat after endotracheal intubation is unfortunately common, with estimates ranging from 15-50%. Most estimates are in the order of 35-45%.(McHardy 1999, Higgins 2002) There is evidence that many patients do not report sore throat and/or vocal changes unless directly asked because surgical pain is more prominent and many patients may be unaware that intubation completed as part of the general anesthetic. (Harding 1987) The Parker FlexTip® endotracheal tube (ETT) is formulated with a softer plastic at the distal tip as well as a laterally curved profile to reduce trauma during ETT advancement. (Makino 2003) This ETT has been shown to be faster during fibreoptic intubation, but complication of sore throat was not examined. (Kristensen 2003) Our previous study (Jones 2007) demonstrated that modification of anesthetic techniques could reduce the incidence of post-operative sore throat in patients undergoing naso-tracheal intubation. We will now study the Parker Flex-Tip ETT to see if its use can also reduce the incidence of sore throat in patients undergoing oro-tracheal intubation.

Conditions

Interventions

TypeNameDescription
DEVICEFlexTip ETT (Parker FlexTip/GlideScope FlexTip)FlexTip ETT used for endotracheal intubation
DEVICEControl - standard flexible ETT (Mallinckrodt)Control - standard flexible ETT Mallinckrodt Hi-Lo cuffed tracheal tube, Catalog # 86114, Mallinckrodt, ST. Louis, MO, 63134

Timeline

Start date
2009-07-01
Primary completion
2010-06-01
Completion
2010-06-01
First posted
2010-03-30
Last updated
2011-08-05

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT01095861. Inclusion in this directory is not an endorsement.