Clinical trial NCT01263873: Examining the Ease of Intubation Using the Parker Flex-Tip® or a Standard Endotracheal Tube
Official title: Examining the Ease of Intubation Using the Parker Flex-Tip® or a Standard Mallinckrodt® Endotracheal When Using the Glidescope®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Larynx
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2010-12-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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 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.

Primary outcomes:
measure: Ease of Intubation, as Measured by Time in Seconds for ETT Insertion
timeFrame: Participants were followed for the duration of intubation, an average of 10 minutes
measure: Ease of Intubation, as Measured by Number of ETT Redirections
timeFrame: Participants were followed for the duration of intubation, an average of 10 minutes
measure: Ease of Intubation, as Measured by an Ease of ETT Insertion Score.
timeFrame: Participants were followed for the duration of intubation, an average of 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Brian P Radesic, DNP, CRNA
role: PRINCIPAL_INVESTIGATOR
References: