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

This study has been completed.
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01095861
First received: September 2, 2009
Last updated: August 4, 2011
Last verified: August 2011
  Purpose

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


Condition Intervention
Endotracheal Intubation
Device: FlexTip ETT (Parker FlexTip/GlideScope FlexTip)
Device: Control - standard flexible ETT (Mallinckrodt)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of Parker Flex-Tip Endotracheal Tube to Standard Endotracheal Tube: A Randomized Controlled Trial

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Sore throat [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Vocal changes [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]

    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.



Enrollment: 200
Study Start Date: July 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FlexTip ETT
FlexTip ETT
Device: FlexTip ETT (Parker FlexTip/GlideScope FlexTip)
FlexTip ETT used for endotracheal intubation
Other Names:
  • Parker FlexTip
  • GlideScope FlexTip
Placebo Comparator: Control
Standard Flexible ETT Mallinckrodt Hi-Lo cuffed tracheal tube Catalog # 86114 Mallinckrodt, ST. Louis, MO, 63134
Device: Control - standard flexible ETT (Mallinckrodt)

Control - standard flexible ETT

Mallinckrodt Hi-Lo cuffed tracheal tube, Catalog # 86114, Mallinckrodt, ST. Louis, MO, 63134


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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01095861

Locations
Canada, Ontario
University of Western Ontario
London, Ontario, Canada, N6A5A5
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Timothy P Turkstra, MD, M. Eng University of Western Ontario, Canada
Principal Investigator: Philip M Jones, MD University of Western Ontario, Canada
  More Information

No publications provided

Responsible Party: Timothy P Turkstra, University of Western Ontario
ClinicalTrials.gov Identifier: NCT01095861     History of Changes
Other Study ID Numbers: R-09-126, 16016
Study First Received: September 2, 2009
Last Updated: August 4, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
endotracheal tube

ClinicalTrials.gov processed this record on August 18, 2014