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

NCT ID: NCT01095861

Last Updated: 2011-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-06-30

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.

Conditions

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Endotracheal Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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FlexTip ETT

FlexTip ETT

Group Type EXPERIMENTAL

FlexTip ETT (Parker FlexTip/GlideScope FlexTip)

Intervention Type DEVICE

FlexTip ETT used for endotracheal intubation

Control

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

Group Type PLACEBO_COMPARATOR

Control - standard flexible ETT (Mallinckrodt)

Intervention Type DEVICE

Control - standard flexible ETT

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

Interventions

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FlexTip ETT (Parker FlexTip/GlideScope FlexTip)

FlexTip ETT used for endotracheal intubation

Intervention Type DEVICE

Control - standard flexible ETT (Mallinckrodt)

Control - standard flexible ETT

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

Intervention Type DEVICE

Other Intervention Names

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Parker FlexTip GlideScope FlexTip

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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University of Western Ontario

Principal Investigators

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Timothy P Turkstra, MD, M. Eng

Role: PRINCIPAL_INVESTIGATOR

Western University, Canada

Philip M Jones, MD

Role: PRINCIPAL_INVESTIGATOR

Western University, Canada

Locations

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University of Western Ontario

London, Ontario, Canada

Site Status

Countries

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Canada

References

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Turkstra TP, Smitheram AK, Alabdulhadi O, Youssef H, Jones PM. The Flex-Tip tracheal tube does not reduce the incidence of postoperative sore throat: a randomized controlled trial. Can J Anaesth. 2011 Dec;58(12):1090-6. doi: 10.1007/s12630-011-9592-5. Epub 2011 Nov 5.

Reference Type DERIVED
PMID: 22057874 (View on PubMed)

Other Identifiers

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16016

Identifier Type: OTHER

Identifier Source: secondary_id

R-09-126

Identifier Type: -

Identifier Source: org_study_id

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