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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):
Jon Samuels, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00602979
First received: January 15, 2008
Last updated: February 17, 2012
Last verified: February 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intubation time: Measured from entry of the device into the oral cavity until confirmation of proper placement of tracheal tube, as judged by an exhaled tidal volume greater than 200ml and the presence of end-tidal carbon dioxide (CO2). [ Time Frame: 1 time during intubation ] [ Designated as safety issue: No ]
  • Success rate: Number of attempts required for successful intubation by an attending anesthesiologist. [ Time Frame: 1 time during intubation ] [ Designated as safety issue: No ]
  • Maximal neck extension: Using Atlanto-occipital joint extension scale. [ Time Frame: 1 time during laryngoscopy/intubation ] [ Designated as safety issue: No ]
  • Ease of intubation: Judged by laryngoscopist on a 5-point rating scale: 5 is excellent, 1 is poor. [ Time Frame: 1 time, after intubation ] [ Designated as safety issue: No ]
  • Complication Rate: All complications will be recorded, with special attention given to common complications, such as upper airway and dental trauma. [ Time Frame: continuous during study participation ] [ Designated as safety issue: No ]
  • Inter-incisor distance: Maximal mouth opening necessary for intubation. [ Time Frame: 1 time during intubation ] [ Designated as safety issue: No ]
  • Laryngoscopist's comments: Pertinent device-specific clinical comments. [ Time Frame: 1 time, after intubation ] [ Designated as safety issue: No ]
  • Vitals signs (blood pressure, heart rate, mean arterial pressure, and pulse oximeter rate) [ Time Frame: pre-intubation ] [ Designated as safety issue: No ]

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
1
Macintosh laryngoscope (control group/direct laryngoscopy) - current standard
 Device: Macintosh laryngoscope
Used during laryngoscopy to facilitate intubation.
2
Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy)
 Device: Airtraq® Optical Laryngoscope
Used during laryngoscopy to facilitate intubation.
3
Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy)
 Device: Storz DCI Video Laryngoscope®
Used during laryngoscopy to facilitate intubation
4
GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy)
 Device: GlideScope® Video Laryngoscope
Used during laryngoscopy to facilitate intubation
5
McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy)
 Device: McGRATH® Video Laryngoscope
Used during laryngoscopy to facilitate intubation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: Jon Samuels, Attending Anesthesiologist, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00602979     History of Changes
Other Study ID Numbers: 0710009433
Study First Received: January 15, 2008
Last Updated: February 17, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013