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

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

Detailed Description
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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.

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

Conditions
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Endotracheal Intubation

Intervention / Treatment
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* Device: FlexTip ETT (Parker FlexTip/GlideScope FlexTip)
* Device: Control - standard flexible ETT (Mallinckrodt)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FlexTip ETT<br>FlexTip ETT | Device: FlexTip ETT (Parker FlexTip/GlideScope FlexTip)<br>* FlexTip ETT used for endotracheal intubation<br>* Other names: GlideScope FlexTip;|
| Placebo Comparator: Control<br>Standard Flexible ETT Mallinckrodt Hi-Lo cuffed tracheal tube Catalog # 86114 Mallinckrodt, ST. Louis, MO, 63134 | Device: Control - standard flexible ETT (Mallinckrodt)<br>* Control - standard flexible ETT Mallinckrodt Hi-Lo cuffed tracheal tube, Catalog # 86114, Mallinckrodt, ST. Louis, MO, 63134<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endotracheal tube