Comparison Study in Adult Surgical Patients of 5 Airway Devices

NCT00602979 | Completed Results

• 1 other identifier: 0710009433
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Laryngoscopy; Intubation

Keywords

endotracheal intubation; intubation; laryngoscopy; laryngoscope; surgery

Outcome Measures

Primary Outcomes (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.

  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

Study Arms (5)

Macintosh laryngoscope

OTHER

Macintosh laryngoscope (control group/direct laryngoscopy) - current standard

Device: Macintosh laryngoscope

Airtraq Optical Laryngoscope

OTHER

Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy)

Device: Airtraq® Optical Laryngoscope

Storz DCI Video Laryngoscope

OTHER

Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy)

Device: Storz DCI Video Laryngoscope®

GlideScope Video Laryngoscope

OTHER

GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy)

Device: GlideScope® Video Laryngoscope

McGRATH Video Laryngoscope

OTHER

McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy)

Device: McGRATH® Video Laryngoscope

Interventions

Macintosh laryngoscope DEVICE

Used during laryngoscopy to facilitate intubation.

Macintosh laryngoscope

Airtraq® Optical Laryngoscope DEVICE

Used during laryngoscopy to facilitate intubation.

Airtraq Optical Laryngoscope

Storz DCI Video Laryngoscope® DEVICE

Used during laryngoscopy to facilitate intubation

Storz DCI Video Laryngoscope

GlideScope® Video Laryngoscope DEVICE

Used during laryngoscopy to facilitate intubation

GlideScope Video Laryngoscope

McGRATH® Video Laryngoscope DEVICE

Used during laryngoscopy to facilitate intubation

McGRATH Video Laryngoscope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective adult surgical patient requiring general endotracheal anesthesia.
• Males and Females.
• ASA Physical Status 1-3.
• Age 18 years of age and older

You may not qualify if:

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

Sponsors & Collaborators

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

Related Publications (1)

• 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.

  PMID: 10671848 BACKGROUND

Results Point of Contact

• Title: Michele Steinkamp
• Organization: Weill Cornell Medicine

mls9004@med.cornell.edu

212-746-2953

Study Officials

• Jon Samuels, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2008
• First Posted: January 28, 2008
• Study Start: April 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: July 1, 2011
• Last Updated: May 19, 2017
• Results First Posted: May 19, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share