Comparison Study in Adult Surgical Patients of 5 Airway Devices

Intubation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00602979
• Other study ID #: 0710009433
• Status: Completed
• Phase: N/A
• First received: January 15, 2008
• Last updated: June 13, 2013
• Start date: April 2008
• Est. completion date: July 2011

Study information

• Verified date: June 2013
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: July 2011
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Intubation
• Laryngoscopy

Intervention

Device:
• Macintosh laryngoscope
Used during laryngoscopy to facilitate intubation.
• Airtraq® Optical Laryngoscope
Used during laryngoscopy to facilitate intubation.
• Storz DCI Video Laryngoscope®
Used during laryngoscopy to facilitate intubation
• GlideScope® Video Laryngoscope
Used during laryngoscopy to facilitate intubation
• McGRATH® Video Laryngoscope
Used during laryngoscopy to facilitate intubation

Locations

Country	Name	City	State
n/a

Sponsors (3)

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

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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).		1 time during intubation	No
Secondary	Success rate: Number of attempts required for successful intubation by an attending anesthesiologist.		1 time during intubation	No
Secondary	Maximal neck extension: Using Atlanto-occipital joint extension scale.		1 time during laryngoscopy/intubation	No
Secondary	Ease of intubation: Judged by laryngoscopist on a 5-point rating scale: 5 is excellent, 1 is poor.		1 time, after intubation	No
Secondary	Complication Rate: All complications will be recorded, with special attention given to common complications, such as upper airway and dental trauma.		continuous during study participation	No
Secondary	Inter-incisor distance: Maximal mouth opening necessary for intubation.		1 time during intubation	No
Secondary	Laryngoscopist's comments: Pertinent device-specific clinical comments.		1 time, after intubation	No
Secondary	Vitals signs (blood pressure, heart rate, mean arterial pressure, and pulse oximeter rate)		pre-intubation	No