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Examining the Ease of Intubation Using the Parker Flex-Tip® or a Standard Endotracheal Tube

NCT ID: NCT01263873

Last Updated: 2014-12-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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There are not many different types of (ETT)s with different ends or tips. The standard (ETT) by Mallinckrodt® is a disposable polyvinyl chloride plastic tube that has one hooded Murphy tip eye at the end of the tube. The Murphy tip eye is to help with ventilation and air passage if the main end is occluded with mucus or a foreign body. Another type of (ETT) is the Parker Flex-Tip® (ETT), which has a soft flex-tip that is configured to pass easily through the airway anatomy and has two Murphy tip eyes. Currently there are no published data comparing the Parker Flex-Tip® (ETT) with standard Mallinckrodt® (ETT) when the GlideScope® is used. The data are limited concerning the ease of intubation when using the Parker Flex-Tip® (ETT). The study is a two-factor randomized block intervention study design. Subjects assigned to the first group will be intubated using the standard Mallinckrodt® (ETT). The subjects assigned to the second group will be intubated using the Parker Flex-Tip® (ETT). Randomization will be accomplished using the sealed envelope technique. There are six anesthesia providers who will be using ETTs to intubate. A block design will be used to make sure each anesthesia provider receives the same number of patients randomized to the Mallinckrodt and to the Parker Flex-Tip® (ETT)s.

Conditions

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Larynx

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Mallinckrodt (ETT)

Artifical Airway Device

Group Type ACTIVE_COMPARATOR

Mallinckrodt (ETT)

Intervention Type DEVICE

7.0 millimeter internal diameter for female 8.0 millimeter internal diameter for male

Parker Flex Tip (ETT)

Artifical Airway Device

Group Type EXPERIMENTAL

Parker Flex-Tip (ETT)

Intervention Type DEVICE

7.0 millimeter internal diameter for female 8.0 millimeter internal diameter for male

Interventions

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Mallinckrodt (ETT)

7.0 millimeter internal diameter for female 8.0 millimeter internal diameter for male

Intervention Type DEVICE

Parker Flex-Tip (ETT)

7.0 millimeter internal diameter for female 8.0 millimeter internal diameter for male

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Subjects that are males and non-pregnant females \> or equal to 18 years of age that require a general anesthetic with an (ETT).
2. Able to give informed consent (adults, English reading and speaking)

Exclusion Criteria

1. Any subject on examination with a mallampati III or greater and/or history of difficult intubation.
2. Any subject with an American Society of Anesthesiologist classification greater than 3.
3. Any subject needing rapid sequence induction.
4. Any subject that the anesthesia provider considers the GlideScope® to be contraindicated.
5. Any subject that an anesthesia provider feels for any reason at any time is not appropriate for inclusion in this study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospitals Cleveland Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Brian Radesic

CRNA

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brian P Radesic, DNP, CRNA

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

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University Hospitals of Cleveland

Cleveland, Ohio, United States

Site Status

Countries

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United States

Related Links

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http://www.parkermedical.com

Parker Flex tip endotracheal tube

Other Identifiers

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04-10-05

Identifier Type: -

Identifier Source: org_study_id