Comparison Study in Adult Surgical Patients of 5 Airway Devices

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

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).

Study Overview

• Status: Completed
• Conditions: Intubation; Laryngoscopy
• Intervention / Treatment: Device: Macintosh laryngoscope; Device: Airtraq® Optical Laryngoscope; Device: Storz DCI Video Laryngoscope®; Device: GlideScope® Video Laryngoscope; Device: McGRATH® Video Laryngoscope

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 Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1 time during laryngoscopy

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: King Systems Corporation; KARL STORZ Endoscopy-America, Inc.
• Investigators: Principal Investigator: Jon Samuels, MD, Weill Medical College of Cornell University

Publications and helpful links

General Publications

• Cook TM. A new practical classification of laryngeal view. Anaesthesia. 2000 Mar;55(3):274-9. doi: 10.1046/j.1365-2044.2000.01270.x.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: January 15, 2008
• First Submitted That Met QC Criteria: January 15, 2008
• First Posted (Estimate): January 28, 2008

Study Record Updates

• Last Update Posted (Actual): May 19, 2017
• Last Update Submitted That Met QC Criteria: April 10, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: endotracheal intubation; surgery; intubation; laryngoscopy; laryngoscope
• Other Study ID Numbers: 0710009433

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No