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

September 2, 2009
August 4, 2011
July 2009
June 2010   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01095861 on ClinicalTrials.gov Archive Site
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.

Same as current
Not Provided
Not Provided
 
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

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Endotracheal Intubation
  • Device: FlexTip ETT (Parker FlexTip/GlideScope FlexTip)
    FlexTip ETT used for endotracheal intubation
    Other Names:
    • Parker FlexTip
    • GlideScope FlexTip
  • Device: Control - standard flexible ETT (Mallinckrodt)

    Control - standard flexible ETT

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

  • Experimental: FlexTip ETT
    FlexTip ETT
    Intervention: Device: FlexTip ETT (Parker FlexTip/GlideScope FlexTip)
  • Placebo Comparator: Control
    Standard Flexible ETT Mallinckrodt Hi-Lo cuffed tracheal tube Catalog # 86114 Mallinckrodt, ST. Louis, MO, 63134
    Intervention: Device: Control - standard flexible ETT (Mallinckrodt)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
June 2010
June 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01095861
R-09-126, 16016
No
Timothy P Turkstra, University of Western Ontario
Lawson Health Research Institute
Not Provided
Principal Investigator: Timothy P Turkstra, MD, M. Eng University of Western Ontario, Canada
Principal Investigator: Philip M Jones, MD University of Western Ontario, Canada
Lawson Health Research Institute
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP