Trial Outcomes & Findings for Examining the Ease of Intubation Using the Parker Flex-Tip® or a Standard Endotracheal Tube (NCT NCT01263873)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

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

Results posted on

2014-12-17

Participant Flow

October, 2010 through January, 2011 in operative room.

Participant milestones

Participant milestones
Measure	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.	Mallinckrodt® Endotracheal Tube Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
Overall Study STARTED	30	30
Overall Study COMPLETED	29	29
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Mallinckrodt® Endotracheal Tube Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
Overall Study One provider unable to complete numbers	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Parker Flex Tip Endotracheal Tube n=30 Participants 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.	Mallinckrodt® Endotracheal Tube n=30 Participants Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Age, Continuous	55 years STANDARD_DEVIATION 14 • n=5 Participants	51 years STANDARD_DEVIATION 19 • n=7 Participants	53 years STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	15 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Parker Flex Tip Endotracheal Tube n=30 Participants 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.	Mallinckrodt® Endotracheal Tube n=30 Participants Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
Ease of Intubation, as Measured by Time in Seconds for ETT Insertion	10.8 Seconds Standard Deviation 7.6	12.7 Seconds Standard Deviation 7.3

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Parker Flex Tip Endotracheal Tube n=30 Participants 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.	Mallinckrodt® Endotracheal Tube n=30 Participants Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
Ease of Intubation, as Measured by Number of ETT Redirections	0.7 Number of redirections to place ETT Standard Deviation 1.4	1.3 Number of redirections to place ETT Standard Deviation 2.8

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Parker Flex Tip Endotracheal Tube n=30 Participants 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.	Mallinckrodt® Endotracheal Tube n=30 Participants Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
Ease of Intubation, as Measured by an Ease of ETT Insertion Score.	12.7 Visual Analog Score in millimeters Standard Deviation 12.4	17.8 Visual Analog Score in millimeters Standard Deviation 19.9

Adverse Events

Parker Flex Tip Endotracheal Tube

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mallinckrodt® Endotracheal Tube

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brian Radesic

University Hospitals of Cleveland

Phone: 3309725175

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place