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Completed

NCT Number: NCT01095861

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

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

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Key information

Conditions

Endotracheal Intubation

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Western Ontario

London, Ontario, N6A5A5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FlexTip ETT (Parker FlexTip/GlideScope FlexTip)

Device

FlexTip ETT used for endotracheal intubation

Other names: Parker FlexTip, GlideScope FlexTip

Control - standard flexible ETT (Mallinckrodt)

Device

Control - standard flexible ETT

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

Primary outcomes

  1. 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

  1. Vocal changes

    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 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.

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 30, 2010
Registry last updated
Aug 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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