Larynx
Conditions
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.
Interventions
DEVICEMallinckrodt (ETT)
7.0 millimeter internal diameter for female 8.0 millimeter internal diameter for male
DEVICEParker Flex-Tip (ETT)
7.0 millimeter internal diameter for female 8.0 millimeter internal diameter for male
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Intubation, as Measured by Time in Seconds for ETT Insertion | Participants were followed for the duration of intubation, an average of 10 minutes | 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 | Participants were followed for the duration of intubation, an average of 10 minutes | 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. | Participants were followed for the duration of intubation, an average of 10 minutes | 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. |
Countries
United States
Participant flow
Recruitment details
October, 2010 through January, 2011 in operative room.
Participants by arm
| Arm | Count |
|---|---|
| Parker Flex Tip Endotracheal Tube Parker Flex-Tip® which is a disposable polyvinyl chloride (PVC) Endotracheal tube with a flexible, tapered tip that is anatomically designed to the airway structures. | 30 |
| Mallinckrodt® Endotracheal Tube Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134. | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | One provider unable to complete numbers | 1 | 1 |
Baseline characteristics
| Characteristic | Mallinckrodt® Endotracheal Tube | Parker Flex Tip Endotracheal Tube | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 9 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 21 Participants | 41 Participants |
| Age, Continuous | 51 years STANDARD_DEVIATION 19 | 55 years STANDARD_DEVIATION 14 | 53 years STANDARD_DEVIATION 16 |
| Region of Enrollment United States | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 15 Participants | 18 Participants | 33 Participants |
| Sex: Female, Male Male | 15 Participants | 12 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
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.
Time frame: Participants were followed for the duration of intubation, an average of 10 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parker Flex Tip Endotracheal Tube | Ease of Intubation, as Measured by an Ease of ETT Insertion Score. | 12.7 Visual Analog Score in millimeters | Standard Deviation 12.4 |
| Mallinckrodt® Endotracheal Tube | Ease of Intubation, as Measured by an Ease of ETT Insertion Score. | 17.8 Visual Analog Score in millimeters | Standard Deviation 19.9 |
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.
Time frame: Participants were followed for the duration of intubation, an average of 10 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parker Flex Tip Endotracheal Tube | Ease of Intubation, as Measured by Number of ETT Redirections | 0.7 Number of redirections to place ETT | Standard Deviation 1.4 |
| Mallinckrodt® Endotracheal Tube | Ease of Intubation, as Measured by Number of ETT Redirections | 1.3 Number of redirections to place ETT | Standard Deviation 2.8 |
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).
Time frame: Participants were followed for the duration of intubation, an average of 10 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parker Flex Tip Endotracheal Tube | Ease of Intubation, as Measured by Time in Seconds for ETT Insertion | 10.8 Seconds | Standard Deviation 7.6 |
| Mallinckrodt® Endotracheal Tube | Ease of Intubation, as Measured by Time in Seconds for ETT Insertion | 12.7 Seconds | Standard Deviation 7.3 |