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Clinical Trials/NCT01095861
NCT01095861
Completed
Not Applicable

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

Lawson Health Research Institute1 site in 1 country200 target enrollmentJuly 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endotracheal Intubation
Sponsor
Lawson Health Research Institute
Enrollment
200
Locations
1
Primary Endpoint
Sore throat
Status
Completed
Last Updated
14 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
July 2009
End Date
June 2010
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Any adult patient scheduled for elective surgery.
  • ETT is indicated for the procedure in the opinion of the attending anesthesiologist.

Exclusion Criteria

  • Any patients with known or probable difficult airways.
  • Any patient requiring rapid sequence induction.

Outcomes

Primary Outcomes

Sore throat

Time Frame: 48-72 hours

Patients fill in a questionaire 48-72 hours after Surgery by a blinded data assessor. They are asked if they had a sore throat after their surgery. If so, they are asked to grade the sore throat as mild, moderate, or severe, when it was at its worst. Note: There is only one questionaire for both outcomes.

Secondary Outcomes

  • Vocal changes(48-72 hours)

Study Sites (1)

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