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

Endotracheal Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01095861
• Other study ID #: R-09-126
• Secondary ID: 16016
• Status: Completed
• Phase: N/A
• First received: September 2, 2009
• Last updated: August 4, 2011
• Start date: July 2009
• Est. completion date: June 2010

Study information

• Verified date: August 2011
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Endotracheal Intubation

Intervention

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

Locations

Country	Name	City	State
Canada	University of Western Ontario	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sore throat	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.	48-72 hours	No
Secondary	Vocal changes	Patients fill in a questionaire 48-72 hours after Surgery by a blinded data assessor.; They are asked if they had vocal changes after their surgery. If so, they are asked to grade the vocal changes as mild, moderate, or severe, when the changes were at its worst. Patients are asked for one word to best characterise the vocal changes.; Note: There is only one questionaire for both outcomes.	48-72 hours	No