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

• Sponsor: University Hospitals Cleveland Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01263873
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 5.9
• Patients Per Site Per Month: 10.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Larynx	Device: Mallinckrodt (ETT); Device: Parker Flex-Tip (ETT)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Official Title: Examining the Ease of Intubation Using the Parker Flex-Tip® or a Standard Mallinckrodt® Endotracheal When Using the Glidescope®
• Study Start Date: Nov 1, 2010
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Mallinckrodt (ETT) Artifical Airway Device	Device: Mallinckrodt (ETT); 7.0 millimeter internal diameter for female 8.0 millimeter internal diameter for male
Experimental: Parker Flex Tip (ETT) Artifical Airway Device	Device: Parker Flex-Tip (ETT); 7.0 millimeter internal diameter for female 8.0 millimeter internal diameter for male

Outcome Measures

Primary Outcome Measures

1. 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).

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

4. Any subject needing rapid sequence induction.

5. Any subject that the anesthesia provider considers the GlideScope® to be contraindicated.

6. Any subject that an anesthesia provider feels for any reason at any time is not appropriate for inclusion in this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals of Cleveland	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

• University Hospitals Cleveland Medical Center

Investigators

• Principal Investigator: Brian P Radesic, DNP, CRNA, University Hospitals Cleveland Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Brian Radesic, CRNA, University Hospitals Cleveland Medical Center
• ClinicalTrials.gov Identifier: NCT01263873
• Other Study ID Numbers: 04-10-05
• First Posted: Dec 21, 2010
• Last Update Posted: Dec 17, 2014
• Last Verified: Dec 1, 2014

Study Results

Participant Flow

Recruitment Details	October, 2010 through January, 2011 in operative room.

Arm/Group Title	Parker Flex Tip Endotracheal Tube	Mallinckrodt® Endotracheal Tube
Arm/Group Description	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.	Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
Period Title: Overall Study
STARTED	30	30
COMPLETED	29	29
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Parker Flex Tip Endotracheal Tube	Mallinckrodt® Endotracheal Tube	Total
Arm/Group Description	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.	Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.	Total of all reporting groups
Overall Participants	30	30	60
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	21 70%	20 66.7%	41 68.3%
>=65 years	9 30%	10 33.3%	19 31.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55 (14)	51 (19)	53 (16)
Sex: Female, Male (Count of Participants)
Female	18 60%	15 50%	33 55%
Male	12 40%	15 50%	27 45%
Region of Enrollment (participants) [Number]
United States	30 100%	30 100%	60 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Parker Flex Tip Endotracheal Tube	Mallinckrodt® Endotracheal Tube
Arm/Group Description	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.	Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
Measure Participants	30	30
Mean (Standard Deviation) [Seconds]	10.8 (7.6)	12.7 (7.3)

2. Primary Outcome

Title	Ease of Intubation, as Measured by Number of ETT Redirections
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Parker Flex Tip Endotracheal Tube	Mallinckrodt® Endotracheal Tube
Arm/Group Description	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.	Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
Measure Participants	30	30
Mean (Standard Deviation) [Number of redirections to place ETT]	0.7 (1.4)	1.3 (2.8)

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Parker Flex Tip Endotracheal Tube	Mallinckrodt® Endotracheal Tube
Arm/Group Description	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.	Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
Measure Participants	30	30
Mean (Standard Deviation) [Visual Analog Score in millimeters]	12.7 (12.4)	17.8 (19.9)

Adverse Events

Arm/Group Title	Parker Flex Tip Endotracheal Tube		Mallinckrodt® Endotracheal Tube
Arm/Group Description	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.		Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
All Cause Mortality
	Parker Flex Tip Endotracheal Tube		Mallinckrodt® Endotracheal Tube
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Parker Flex Tip Endotracheal Tube		Mallinckrodt® Endotracheal Tube
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Parker Flex Tip Endotracheal Tube		Mallinckrodt® Endotracheal Tube
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.