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Comparison Study in Adult Surgical Patients of 5 Airway Devices

This study has been completed.
Sponsor:
Collaborators:
King Systems Corporation
KARL STORZ Endoscopy-America, Inc.
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00602979
First received: January 15, 2008
Last updated: April 10, 2017
Last verified: April 2017
  Purpose
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 Intervention
Laryngoscopy Intubation Device: Macintosh laryngoscope Device: Airtraq® Optical Laryngoscope Device: Storz DCI Video Laryngoscope® Device: GlideScope® Video Laryngoscope Device: McGRATH® Video Laryngoscope

Study Type: Interventional
Study Design: 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

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • 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. [ Time Frame: 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.



Enrollment: 240
Study Start Date: April 2008
Study Completion Date: July 2011
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Macintosh laryngoscope
Macintosh laryngoscope (control group/direct laryngoscopy) - current standard
Device: Macintosh laryngoscope
Used during laryngoscopy to facilitate intubation.
Airtraq Optical Laryngoscope
Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy)
Device: Airtraq® Optical Laryngoscope
Used during laryngoscopy to facilitate intubation.
Storz DCI Video Laryngoscope
Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy)
Device: Storz DCI Video Laryngoscope®
Used during laryngoscopy to facilitate intubation
GlideScope Video Laryngoscope
GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy)
Device: GlideScope® Video Laryngoscope
Used during laryngoscopy to facilitate intubation
McGRATH Video Laryngoscope
McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy)
Device: McGRATH® Video Laryngoscope
Used during laryngoscopy to facilitate intubation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00602979

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
  More Information

Publications:
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00602979     History of Changes
Other Study ID Numbers: 0710009433
Study First Received: January 15, 2008
Results First Received: February 17, 2017
Last Updated: April 10, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Weill Medical College of Cornell University:
endotracheal intubation
intubation
laryngoscopy
laryngoscope
surgery

ClinicalTrials.gov processed this record on August 18, 2017