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| Name | Class |
|---|---|
| King Systems Corporation | INDUSTRY |
| KARL STORZ Endoscopy-America, Inc. | INDUSTRY |
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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).
Historically, optical and video laryngoscopes have been used as alternative airway management devices for the difficult airway, and as rescue devices. Their use by experienced laryngoscopists has not been compared in a prospective, randomized, head-to-head comparison for routine airway management in adult surgical patients. Video and optical laryngoscopes have been developed to improve the laryngeal view for tracheal intubation and to decrease physiological stress associated with the procedure. The objective of this study is to determine whether these devices offer superior intubating conditions for routine surgical management, over the Macintosh laryngoscope, which is the current standard. The devices to be compared in this study are the most commonly used video and optical laryngoscopes on the market and are cleared or exempt by the Food and Drug Administration (FDA).
Eligible subjects include elective adult surgical patients with an ASA status between 1 and 3 requiring general endotracheal anesthesia. Subjects with a BMI ≥ 40, or undergoing surgery in close proximity to the neck will be excluded. Prior to surgery, subjects will receive a pre-anesthesia evaluation with particular attention to the airway using the Mallampati classification system; atlanto-occipital joint extension; thyro-mental distance; temporomandibular joint function; inter-incisor distance; and dental assessment. Subjects will be randomized for intubation with one of the five laryngoscopes in equal proportions. The following data were recorded: total intubation time, maximum neck extension using an angle gauge, glottic view, assessed by the anesthesiologist using the Cook modification of the Cormack-Lehane grading system (Figure 1), and ease of tracheal intubation using a 5-point rating scale; 5 (excellent) to 1 (poor). Subjects were queried about soreness or painful swallowing in the PACU and a week later via a phone call.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Macintosh laryngoscope | Other | Macintosh laryngoscope (control group/direct laryngoscopy) - current standard |
|
| Airtraq Optical Laryngoscope | Other | Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy) |
|
| Storz DCI Video Laryngoscope | Other | Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy) |
|
| GlideScope Video Laryngoscope | Other | GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy) |
|
| McGRATH Video Laryngoscope | Other | McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macintosh laryngoscope | Device | Used during laryngoscopy to facilitate intubation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon Samuels, MD | Weill Medical College of Cornell University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10671848 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Macintosh Laryngoscope | Macintosh laryngoscope (control group/direct laryngoscopy) - current standard Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation. |
| FG001 | Airtraq Optical Laryngoscope | Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy) Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation. |
| FG002 | Storz DCI Video Laryngoscope | Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy) Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation |
| FG003 | GlideScope Video Laryngoscope | GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy) GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation |
| FG004 | McGRATH Video Laryngoscope | McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy) McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Macintosh Laryngoscope | Macintosh laryngoscope (control group/direct laryngoscopy) - current standard Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation. |
| BG001 | Airtraq Optical Laryngoscope |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 1 time during laryngoscopy |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Macintosh Laryngoscope | Macintosh laryngoscope (control group/direct laryngoscopy) - current standard Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal Laceration | Eye disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Swollen Lip | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michele Steinkamp | Weill Cornell Medicine | 212-746-2953 | mls9004@med.cornell.edu |
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| Airtraq® Optical Laryngoscope | Device | Used during laryngoscopy to facilitate intubation. |
|
| Storz DCI Video Laryngoscope® | Device | Used during laryngoscopy to facilitate intubation |
|
| GlideScope® Video Laryngoscope | Device | Used during laryngoscopy to facilitate intubation |
|
| McGRATH® Video Laryngoscope | Device | Used during laryngoscopy to facilitate intubation |
|
| Failed Intubation |
|
Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy)
Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation.
| BG002 | Storz DCI Video Laryngoscope | Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy) Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation |
| BG003 | GlideScope Video Laryngoscope | GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy) GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation |
| BG004 | McGRATH Video Laryngoscope | McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy) McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Macintosh laryngoscope (control group/direct laryngoscopy) - current standard Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation. |
| OG001 | Airtraq Optical Laryngoscope | Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy) Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation. |
| OG002 | Storz DCI Video Laryngoscope | Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy) Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation |
| OG003 | GlideScope Video Laryngoscope | GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy) GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation |
| OG004 | McGRATH Video Laryngoscope | McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy) McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation |
|
|
| 0 |
| 48 |
| 2 |
| 48 |
| 0 |
| 48 |
| EG001 | Airtraq Optical Laryngoscope | Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy) Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation. | 0 | 48 | 0 | 48 | 0 | 48 |
| EG002 | Storz DCI Video Laryngoscope | Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy) Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation | 0 | 48 | 0 | 48 | 0 | 48 |
| EG003 | GlideScope Video Laryngoscope | GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy) GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation | 0 | 48 | 0 | 48 | 0 | 48 |
| EG004 | McGRATH Video Laryngoscope | McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy) McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation | 0 | 48 | 1 | 48 | 1 | 48 |
| Iliac Vein Rupture | Vascular disorders | Non-systematic Assessment |
|
| Right Tonsillar Pillar Laceration | Blood and lymphatic system disorders | Non-systematic Assessment |
|
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