Comparison Study in Adult Surgical Patients of 5 Airway Devices

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00602979
• Collaborator: King Systems Corporation (Industry), KARL STORZ Endoscopy-America, Inc. (Industry)
• Enrollment: 240
• Arms: 5
• Duration (Months): 39

Study Details

Study Description

Brief Summary

The placement of endotracheal tubes (intubation) is a physiologically stressful procedure for patients. Laryngoscopes are devices-typically composed of a blade attached to a handle with a light source-that allow examination of the upper airway through the mouth, often for the purposes of intubation. Recently some new laryngoscope devices (including the Airtraq® Optical Laryngoscope, the Storz DCI Video laryngoscope®, McGRATH® Video Laryngoscope, and the GlideScope®) have been developed, which may either decrease the stress related to intubation (reduce neck extension, reduce risk of complications or reduce time elapsed during intubation) or improve intubation success (reduce the number of attempts at intubating). Data are being collected in this study to determine which of these commonly-used devices may be better, particularly in comparison to the current hospital standard, the Macintosh laryngoscope. All of the devices to be used in this study are currently cleared or exempt by the Food and Drug Administration (FDA).

Condition or Disease	Intervention/Treatment	Phase
Laryngoscopy; Intubation	Device: Macintosh laryngoscope; Device: Airtraq® Optical Laryngoscope; Device: Storz DCI Video Laryngoscope®; Device: GlideScope® Video Laryngoscope; Device: McGRATH® Video Laryngoscope	N/A

Detailed Description

Historically, optical and video laryngoscopes have been used as alternative airway management devices for the difficult airway, and as rescue devices. Their use by experienced laryngoscopists has not been compared in a prospective, randomized, head-to-head comparison for routine airway management in adult surgical patients. Video and optical laryngoscopes have been developed to improve the laryngeal view for tracheal intubation and to decrease physiological stress associated with the procedure. The objective of this study is to determine whether these devices offer superior intubating conditions for routine surgical management, over the Macintosh laryngoscope, which is the current standard. The devices to be compared in this study are the most commonly used video and optical laryngoscopes on the market and are cleared or exempt by the Food and Drug Administration (FDA).

Eligible subjects include elective adult surgical patients with an ASA status between 1 and 3 requiring general endotracheal anesthesia. Subjects with a BMI ≥ 40, or undergoing surgery in close proximity to the neck will be excluded. Prior to surgery, subjects will receive a pre-anesthesia evaluation with particular attention to the airway using the Mallampati classification system; atlanto-occipital joint extension; thyro-mental distance; temporomandibular joint function; inter-incisor distance; and dental assessment. Subjects will be randomized for intubation with one of the five laryngoscopes in equal proportions. The following data were recorded: total intubation time, maximum neck extension using an angle gauge, glottic view, assessed by the anesthesiologist using the Cook modification of the Cormack-Lehane grading system (Figure 1), and ease of tracheal intubation using a 5-point rating scale; 5 (excellent) to 1 (poor). Subjects were queried about soreness or painful swallowing in the PACU and a week later via a phone call.

Study Design

• Study Type: Interventional
• Actual Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: Prospective, Randomized Comparison of Intubating Conditions With Airtraq Optical, Storz DCI Video, McGRATH Video, GlideScope Video, & Macintosh Laryngoscope in Randomly Selected Elective Adult Surgical Patients
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: Macintosh laryngoscope Macintosh laryngoscope (control group/direct laryngoscopy) - current standard	Device: Macintosh laryngoscope; Used during laryngoscopy to facilitate intubation.
Other: Airtraq Optical Laryngoscope Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy)	Device: Airtraq® Optical Laryngoscope; Used during laryngoscopy to facilitate intubation.
Other: Storz DCI Video Laryngoscope Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy)	Device: Storz DCI Video Laryngoscope®; Used during laryngoscopy to facilitate intubation
Other: GlideScope Video Laryngoscope GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy)	Device: GlideScope® Video Laryngoscope; Used during laryngoscopy to facilitate intubation
Other: McGRATH Video Laryngoscope McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy)	Device: McGRATH® Video Laryngoscope; Used during laryngoscopy to facilitate intubation

Outcome Measures

Primary Outcome Measures

1. Percentage Distribution of Cook's Modification of Cormack-Lehane's Grading System. Each Study Subject Will Receive a Grade of 1, 2A, 2B, 3A, 3B, or 4 in the Cormack-Lehane Grading System. [1 time during laryngoscopy]

   Percentage distribution of Cook's modification of Cormack-Lehane's grading system. This is a classification that records the best laryngeal view obtained with or without anterior laryngeal pressure. Each study subject will receive a grade of 1, 2A, 2B, 3A, 3B, or 4 in the Cormack-Lehane grading system. Grades 1 and 2A classify as an easy view: when the laryngeal inlet is visible. Grades 2B and 3A classify as restricted: when the posterior glottic structures are visible or the epiglottis is visible and can be lifted. Grades 3B and 4 classify as difficult: when the epiglottis cannot be lifted or when no laryngeal structures are visible. Cook's modification of Cormack-Lehane's Grades 1=1, 2=2A,3=2B, 4=3A, 5=3B, 6=4.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Elective adult surgical patient requiring general endotracheal anesthesia.

• Males and Females.

• ASA Physical Status 1-3.

• Age 18 years of age and older

Exclusion Criteria:

• Body Mass Index (BMI) ≥35kg/m2.

• If subject is of childbearing potential, a positive pregnancy test at the time of study enrollment.

• Has physical, mental, or medical conditions which, in the opinion of the Investigator, could compromise the subject's welfare, ability to communicate with the study staff, complete study activities, or would otherwise contraindicate study participation.

• Intubated prior to surgery.

• Severe cardiovascular, hepatic or renal disease.

• Need for nasal intubation.

• An investigator of this study.

• Inclusion in another clinical research study.

• Subject's refusal or inability to agree to and to sign the Informed Consent Form in English.

• Subject requiring awake airway management.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Weill Medical College of Cornell University
• King Systems Corporation
• KARL STORZ Endoscopy-America, Inc.

Investigators

• Principal Investigator: Jon Samuels, MD, Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Cook TM. A new practical classification of laryngeal view. Anaesthesia. 2000 Mar;55(3):274-9.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT00602979
• Other Study ID Numbers: 0710009433
• First Posted: Jan 28, 2008
• Last Update Posted: May 19, 2017
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Weill Medical College of Cornell University: endotracheal intubation; intubation; laryngoscopy; laryngoscope; surgery

Study Results

Participant Flow

Arm/Group Title	Macintosh Laryngoscope	Airtraq Optical Laryngoscope	Storz DCI Video Laryngoscope	GlideScope Video Laryngoscope	McGRATH Video Laryngoscope
Arm/Group Description	Macintosh laryngoscope (control group/direct laryngoscopy) - current standard Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation.	Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy) Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation.	Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy) Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation	GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy) GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation	McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy) McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation
Period Title: Overall Study
STARTED	48	48	48	48	48
COMPLETED	45	45	45	45	45
NOT COMPLETED	3	3	3	3	3

Baseline Characteristics

Arm/Group Title	Macintosh Laryngoscope	Airtraq Optical Laryngoscope	Storz DCI Video Laryngoscope	GlideScope Video Laryngoscope	McGRATH Video Laryngoscope	Total
Arm/Group Description	Macintosh laryngoscope (control group/direct laryngoscopy) - current standard Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation.	Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy) Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation.	Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy) Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation	GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy) GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation	McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy) McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation	Total of all reporting groups
Overall Participants	48	48	48	48	48	240
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.3 (16.9)	46.1 (13.5)	47.8 (15.4)	50.0 (15.2)	49.3 (15.8)	48.7 (15.4)
Sex: Female, Male (Count of Participants)
Female	20 41.7%	25 52.1%	21 43.8%	25 52.1%	23 47.9%	114 47.5%
Male	28 58.3%	23 47.9%	27 56.3%	23 47.9%	25 52.1%	126 52.5%

Outcome Measures

1. Primary Outcome

Title	Percentage Distribution of Cook's Modification of Cormack-Lehane's Grading System. Each Study Subject Will Receive a Grade of 1, 2A, 2B, 3A, 3B, or 4 in the Cormack-Lehane Grading System.
Description	Percentage distribution of Cook's modification of Cormack-Lehane's grading system. This is a classification that records the best laryngeal view obtained with or without anterior laryngeal pressure. Each study subject will receive a grade of 1, 2A, 2B, 3A, 3B, or 4 in the Cormack-Lehane grading system. Grades 1 and 2A classify as an easy view: when the laryngeal inlet is visible. Grades 2B and 3A classify as restricted: when the posterior glottic structures are visible or the epiglottis is visible and can be lifted. Grades 3B and 4 classify as difficult: when the epiglottis cannot be lifted or when no laryngeal structures are visible. Cook's modification of Cormack-Lehane's Grades 1=1, 2=2A,3=2B, 4=3A, 5=3B, 6=4.
Time Frame	1 time during laryngoscopy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Macintosh Laryngoscope	Airtraq Optical Laryngoscope	Storz DCI Video Laryngoscope	GlideScope Video Laryngoscope	McGRATH Video Laryngoscope
Arm/Group Description	Macintosh laryngoscope (control group/direct laryngoscopy) - current standard Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation.	Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy) Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation.	Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy) Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation	GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy) GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation	McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy) McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation
Measure Participants	45	45	45	45	45
Mean (Standard Deviation) [units on a scale]	1.98 (1.96)	1.18 (0.44)	1.27 (0.54)	1.47 (0.59)	1.13 (0.34)

Adverse Events

Arm/Group Title	Macintosh Laryngoscope		Airtraq Optical Laryngoscope		Storz DCI Video Laryngoscope		GlideScope Video Laryngoscope		McGRATH Video Laryngoscope
Arm/Group Description	Macintosh laryngoscope (control group/direct laryngoscopy) - current standard Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation.		Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy) Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation.		Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy) Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation		GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy) GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation		McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy) McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation
All Cause Mortality
	Macintosh Laryngoscope		Airtraq Optical Laryngoscope		Storz DCI Video Laryngoscope		GlideScope Video Laryngoscope		McGRATH Video Laryngoscope
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		0/48 (0%)		0/48 (0%)		0/48 (0%)		0/48 (0%)
Serious Adverse Events
	Macintosh Laryngoscope		Airtraq Optical Laryngoscope		Storz DCI Video Laryngoscope		GlideScope Video Laryngoscope		McGRATH Video Laryngoscope
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/48 (4.2%)		0/48 (0%)		0/48 (0%)		0/48 (0%)		1/48 (2.1%)
Blood and lymphatic system disorders
Right Tonsillar Pillar Laceration	0/48 (0%)	0	0/48 (0%)	0	0/48 (0%)	0	0/48 (0%)	0	1/48 (2.1%)	1
Eye disorders
Corneal Laceration	1/48 (2.1%)	1	0/48 (0%)	0	0/48 (0%)	0	0/48 (0%)	0	0/48 (0%)	0
Vascular disorders
Iliac Vein Rupture	1/48 (2.1%)	1	0/48 (0%)	0	0/48 (0%)	0	0/48 (0%)	0	0/48 (0%)	0
Other (Not Including Serious) Adverse Events
	Macintosh Laryngoscope		Airtraq Optical Laryngoscope		Storz DCI Video Laryngoscope		GlideScope Video Laryngoscope		McGRATH Video Laryngoscope
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		0/48 (0%)		0/48 (0%)		0/48 (0%)		1/48 (2.1%)
General disorders
Swollen Lip	0/48 (0%)	0	0/48 (0%)	0	0/48 (0%)	0	0/48 (0%)	0	1/48 (2.1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.