N/A
N=60
Examining the Ease of Intubation Using the Parker Flex-Tip® or a Standard Endotracheal Tube
Larynx
Bottom Line
View on ClinicalTrials.gov: NCT01263873 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcome: Primary: Ease of Intubation, as Measured by Time in Seconds for ETT Insertion — 10.8; 12.7 Seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mallinckrodt (ETT) (Device); Parker Flex-Tip (ETT) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospitals Cleveland Medical Center
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ease of Intubation, as Measured by Time in Seconds for ETT Insertion |
10.8; 12.7 | — |
| PRIMARY Ease of Intubation, as Measured by Number of ETT Redirections |
0.7; 1.3 | — |
| PRIMARY Ease of Intubation, as Measured by an Ease of ETT Insertion Score. |
12.7; 17.8 | — |
Summary
The purpose of the study is to determine if there are differences related to ease of intubation reported by clinicians who use the Parker Flex-Tip® endotracheal tubes(ETT)compared to the standard Mallinckrodt® (ETT). The problem is two (ETTs), the Parker Flex-Tip® and the Mallinckrodt®, are currently available for use in operative suites for intubation, but few studies have compared these devices with each other. Two research questions to be answered in the study are 1. Is there a difference in the ease of intubation when the Parker Flex-Tip® (ETT) is used when compared to the standard Mallinckrodt® (ETT)? and 2. Are there differences in the number of successful intubations when comparing the Parker Flex-Tip® (ETT) and the standard Mallinckrodt® (ETT)? The hypotheses are the use of the Parker Flex-Tip® (ETT) will demonstrate: 1. Fewer seconds to intubate the trachea. 2. Higher self-reported ease of placement scores and 3. Fewer redirections to intubate the trachea. The number of successful intubations is expected to be the same in both arms of the study.
Eligibility Criteria
Inclusion Criteria
- Subjects that are males and non-pregnant females > or equal to 18 years of age that require a general anesthetic with an (ETT).
- Able to give informed consent (adults, English reading and speaking)
Exclusion Criteria
- Any subject on examination with a mallampati III or greater and/or history of difficult intubation.
- Any subject with an American Society of Anesthesiologist classification greater than 3.
- Any subject needing rapid sequence induction.
- Any subject that the anesthesia provider considers the GlideScope® to be contraindicated.
- Any subject that an anesthesia provider feels for any reason at any time is not appropriate for inclusion in this study.
Data sourced from ClinicalTrials.gov (NCT01263873). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.