Comparison of Parker Flex-Tip Endotracheal Tube to Standard Endotracheal Tube
2 other identifiers
interventional
200
1 country
1
Brief Summary
Patients presenting for elective surgery requiring tracheal intubation will be randomized to one of two different endotracheal tubes (ETT).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 2, 2009
CompletedFirst Posted
Study publicly available on registry
March 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedAugust 5, 2011
August 1, 2011
11 months
September 2, 2009
August 4, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Vocal changes
48-72 hours
Study Arms (2)
FlexTip ETT
EXPERIMENTALFlexTip ETT
Control
PLACEBO COMPARATORStandard Flexible ETT Mallinckrodt Hi-Lo cuffed tracheal tube Catalog # 86114 Mallinckrodt, ST. Louis, MO, 63134
Interventions
FlexTip ETT used for endotracheal intubation
Control - standard flexible ETT Mallinckrodt Hi-Lo cuffed tracheal tube, Catalog # 86114, Mallinckrodt, ST. Louis, MO, 63134
Eligibility Criteria
You may qualify if:
- Any adult patient scheduled for elective surgery.
- ETT is indicated for the procedure in the opinion of the attending anesthesiologist.
You may not qualify if:
- Any patients with known or probable difficult airways.
- Any patient requiring rapid sequence induction.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Western Ontario
London, Ontario, N6A5A5, Canada
Related Publications (1)
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.
PMID: 22057874DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy P Turkstra, MD, M. Eng
Western University, Canada
- PRINCIPAL INVESTIGATOR
Philip M Jones, MD
Western University, Canada
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 2, 2009
First Posted
March 30, 2010
Study Start
July 1, 2009
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
August 5, 2011
Record last verified: 2011-08