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

Larynx Clinical Trial

— ETT  

Official title:

Examining the Ease of Intubation Using the Parker Flex-Tip® or a Standard Mallinckrodt® Endotracheal When Using the Glidescope®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01263873
• Other study ID #: 04-10-05
• Status: Completed
• Phase: N/A
• First received: December 17, 2010
• Last updated: December 2, 2014
• Start date: November 2010
• Est. completion date: May 2011

Study information

• Verified date: December 2014
• Source: University Hospital Case Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Larynx

Intervention

Device:
• Mallinckrodt (ETT)
7.0 millimeter internal diameter for female 8.0 millimeter internal diameter for male
• Parker Flex-Tip (ETT)
7.0 millimeter internal diameter for female 8.0 millimeter internal diameter for male

Locations

Country	Name	City	State
United States	University Hospitals of Cleveland	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Case Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No

External Links

•   Parker Flex tip endotracheal tube