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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brian Radesic, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT01263873
First received: December 17, 2010
Last updated: November 14, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Larynx
Device: Mallinckrodt (ETT)
Device: Parker Flex-Tip (ETT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Examining the Ease of Intubation Using the Parker Flex-Tip® or a Standard Mallinckrodt® Endotracheal When Using the Glidescope®

Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • Ease of Intubation, as Measured by Time in Seconds for ETT Insertion [ Time Frame: Participants were followed for the duration of intubation, an average of 10 minutes ] [ Designated as safety issue: No ]
    To measure the ease of intubation by time in seconds for ETT insertion. Time was measured in seconds and started when the anesthesia provider asked for the ETT and stopped once the ETT was placed through the glottis. The time was obtained from video recordings during the intubation by the principal investigator (PI).

  • Ease of Intubation, as Measured by Number of ETT Redirections [ Time Frame: Participants were followed for the duration of intubation, an average of 10 minutes ] [ Designated as safety issue: No ]
    To measure the ease of intubation, once the airway structure was visualized with the GlideScope, the number of ETT redirections at the glottis to intubate the trachea was counted by video recordings by the PI.

  • Ease of Intubation, as Measured by an Ease of ETT Insertion Score. [ Time Frame: Participants were followed for the duration of intubation, an average of 10 minutes ] [ Designated as safety issue: No ]
    To measure the ease of intubation, an ease of ETT insertion score was obtained by using a 100 millimeter visual analog scale done by the anesthesia provider doing the intubation. The score of 0 millimeters was the easiest intubation and a score of 100 millimeters was the hardest intubation done by that anesthesia provider.


Enrollment: 60
Study Start Date: November 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mallinckrodt (ETT)
Artifical Airway Device
Device: Mallinckrodt (ETT)
7.0 millimeter internal diameter for female 8.0 millimeter internal diameter for male
Experimental: Parker Flex Tip (ETT)
Artifical Airway Device
Device: Parker Flex-Tip (ETT)
7.0 millimeter internal diameter for female 8.0 millimeter internal diameter for male

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01263873

Locations
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospital Case Medical Center
Investigators
Principal Investigator: Brian P Radesic, DNP, CRNA University Hospital Case Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Brian Radesic, CRNA, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT01263873     History of Changes
Other Study ID Numbers: 04-10-05
Study First Received: December 17, 2010
Results First Received: May 26, 2011
Last Updated: November 14, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 19, 2014