N/A
N=240
Comparison Study in Adult Surgical Patients of 5 Airway Devices
Laryngoscopy · Intubation
Bottom Line
View on ClinicalTrials.gov: NCT00602979 ↗Enrolled (actual)
240
Serious AEs
1.3%
Results posted
May 2017
Primary outcome: 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. — 1.98; 1.18; 1.27; 1.47 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Macintosh laryngoscope (Device); Airtraq® Optical Laryngoscope (Device); Storz DCI Video Laryngoscope® (Device); GlideScope® Video Laryngoscope (Device); McGRATH® Video Laryngoscope (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
1.98; 1.18; 1.27; 1.47; 1.13 | — |
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).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00602979). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.