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
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).
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Weill Medical College of Cornell University | KARL STORZ Endoscopy-America, Inc., King Systems Corporation |
Cook TM. A new practical classification of laryngeal view. Anaesthesia. 2000 Mar;55(3):274-9. — View Citation
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 |
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