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

NCT01263873 | Completed Results DMC

• 1 other identifier: 04-10-05
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Larynx

Outcome Measures

Primary Outcomes (3)

• Ease of Intubation, as Measured by Time in Seconds for ETT Insertion

  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).

  Participants were followed for the duration of intubation, an average of 10 minutes

• Ease of Intubation, as Measured by Number of ETT Redirections

  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.

  Participants were followed for the duration of intubation, an average of 10 minutes

• Ease of Intubation, as Measured by an Ease of ETT Insertion Score.

  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.

  Participants were followed for the duration of intubation, an average of 10 minutes

Study Arms (2)

Mallinckrodt (ETT)

ACTIVE COMPARATOR

Artifical Airway Device

Device: Mallinckrodt (ETT)

Parker Flex Tip (ETT)

EXPERIMENTAL

Artifical Airway Device

Device: Parker Flex-Tip (ETT)

Interventions

Mallinckrodt (ETT) DEVICE

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

Mallinckrodt (ETT)

Parker Flex-Tip (ETT) DEVICE

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

Parker Flex Tip (ETT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Related Links

• Parker Flex tip endotracheal tube

MeSH Terms

Conditions

Laryngeal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Limitations and Caveats

Limitations of this study included an un-blinded use of ETTs

Results Point of Contact

• Title: Brian Radesic
• Organization: University Hospitals of Cleveland

radesic@uakron.edu

3309725175

Study Officials

• Brian P Radesic, DNP, CRNA

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CRNA

Study Record Dates

• First Submitted: December 17, 2010
• First Posted: December 21, 2010
• Study Start: November 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: December 17, 2014
• Results First Posted: December 19, 2011

Record last verified: 2014-12

Locations

US (1)