## Protocol Section
### Identification Module
**NCT ID:** NCT00602979

**Brief Title:** Comparison Study in Adult Surgical Patients of 5 Airway Devices

**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

#### Organization Study ID Info
**ID:** 0710009433
#### Organization
**Class:** OTHER
**Full Name:** Weill Medical College of Cornell University
### Status Module
#### Completion Date
**Date:** 2011-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-05-19

**Type:** ACTUAL

**Last Update Submit Date:** 2017-04-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2009-09

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2017-05-19

**Type:** ACTUAL

**Results First Submit Date:** 2017-02-17

**Results First Submit QC Date:** 2017-04-10

#### Start Date
**Date:** 2008-04

**Status Verified Date:** 2017-04

#### Study First Post Date
**Date:** 2008-01-28
**Type:** ESTIMATED
**Study First Submit Date:** 2008-01-15
**Study First Submit QC Date:** 2008-01-15
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** King Systems Corporation

**Class:** INDUSTRY

**Name:** KARL STORZ Endoscopy-America, Inc.

#### Lead Sponsor

**Class:** OTHER

**Name:** Weill Medical College of Cornell University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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).

**Detailed Description:** 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.

### Conditions Module

**Conditions:**

- Laryngoscopy

- Intubation

**Keywords:**

- endotracheal intubation

- intubation

- laryngoscopy

- laryngoscope

- surgery

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 240

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Device: Macintosh laryngoscope

**Label:** Macintosh laryngoscope

**Type:** OTHER

#### Arm Group 2

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

**Intervention Names:**

- Device: Airtraq® Optical Laryngoscope

**Label:** Airtraq Optical Laryngoscope

**Type:** OTHER

#### Arm Group 3

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

**Intervention Names:**

- Device: Storz DCI Video Laryngoscope®

**Label:** Storz DCI Video Laryngoscope

**Type:** OTHER

#### Arm Group 4

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

**Intervention Names:**

- Device: GlideScope® Video Laryngoscope

**Label:** GlideScope Video Laryngoscope

**Type:** OTHER

#### Arm Group 5

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

**Intervention Names:**

- Device: McGRATH® Video Laryngoscope

**Label:** McGRATH Video Laryngoscope

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Macintosh laryngoscope

**Description:** Used during laryngoscopy to facilitate intubation.

**Name:** Macintosh laryngoscope

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Airtraq Optical Laryngoscope

**Description:** Used during laryngoscopy to facilitate intubation.

**Name:** Airtraq® Optical Laryngoscope

**Type:** DEVICE

#### Intervention 3

**Arm Group Labels:**

- Storz DCI Video Laryngoscope

**Description:** Used during laryngoscopy to facilitate intubation

**Name:** Storz DCI Video Laryngoscope®

**Type:** DEVICE

#### Intervention 4

**Arm Group Labels:**

- GlideScope Video Laryngoscope

**Description:** Used during laryngoscopy to facilitate intubation

**Name:** GlideScope® Video Laryngoscope

**Type:** DEVICE

#### Intervention 5

**Arm Group Labels:**

- McGRATH Video Laryngoscope

**Description:** Used during laryngoscopy to facilitate intubation

**Name:** McGRATH® Video Laryngoscope

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** 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.

**Time Frame:** 1 time during laryngoscopy

### Eligibility Module

**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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Weill Medical College of Cornell University

**Name:** Jon Samuels, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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

## Derived Section

### Misc Info Module

#### Removed Countries

- Country: United States

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Macintosh Laryngoscope

**Deaths Num At Risk:** 48

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

Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation.

**ID:** EG000

**Other Num at Risk:** 48

**Serious Number Affected:** 2

**Serious Number At Risk:** 48

**Title:** Macintosh Laryngoscope

**Group ID:** EG001

**Title:** Airtraq Optical Laryngoscope

**Deaths Num At Risk:** 48

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

Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation.

**ID:** EG001

**Other Num at Risk:** 48

**Serious Number At Risk:** 48

**Title:** Airtraq Optical Laryngoscope

**Group ID:** EG002

**Title:** Storz DCI Video Laryngoscope

**Deaths Num At Risk:** 48

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

Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation

**ID:** EG002

**Other Num at Risk:** 48

**Serious Number At Risk:** 48

**Title:** Storz DCI Video Laryngoscope

**Group ID:** EG003

**Title:** GlideScope Video Laryngoscope

**Deaths Num At Risk:** 48

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

GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation

**ID:** EG003

**Other Num at Risk:** 48

**Serious Number At Risk:** 48

**Title:** GlideScope Video Laryngoscope

**Group ID:** EG004

**Title:** McGRATH Video Laryngoscope

**Deaths Num At Risk:** 48

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

McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation

**ID:** EG004

**Other Num Affected:** 1

**Other Num at Risk:** 48

**Serious Number Affected:** 1

**Serious Number At Risk:** 48

**Title:** McGRATH Video Laryngoscope

**Frequency Threshold:** 2

#### Other Events

**Term:** Swollen Lip

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

#### Serious Events

**Term:** Corneal Laceration

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 48

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 48

**Group ID:** EG002

**Num At Risk:** 48

**Group ID:** EG003

**Num At Risk:** 48

**Group ID:** EG004

**Num At Risk:** 48

**Term:** Iliac Vein Rupture

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 48

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 48

**Group ID:** EG002

**Num At Risk:** 48

**Group ID:** EG003

**Num At Risk:** 48

**Group ID:** EG004

**Num At Risk:** 48

**Term:** Right Tonsillar Pillar Laceration

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 48

**Group ID:** EG001

**Num At Risk:** 48

**Group ID:** EG002

**Num At Risk:** 48

**Group ID:** EG003

**Num At Risk:** 48

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 48

**Num Events:** 1

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 48

**Group ID:** BG001

**Value:** 48

**Group ID:** BG002

**Value:** 48

**Group ID:** BG003

**Value:** 48

**Group ID:** BG004

**Value:** 48

**Group ID:** BG005

**Value:** 240

**Units:** Participants

### Group

**ID:** BG000

**Title:** Macintosh Laryngoscope

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

Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation.

### Group

**ID:** BG001

**Title:** Airtraq Optical Laryngoscope

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

Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation.

### Group

**ID:** BG002

**Title:** Storz DCI Video Laryngoscope

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

Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation

### Group

**ID:** BG003

**Title:** GlideScope Video Laryngoscope

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

GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation

### Group

**ID:** BG004

**Title:** McGRATH Video Laryngoscope

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

McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation

### Group

**ID:** BG005

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 16.9

**Value:** 50.3

#### Measurement

**Group ID:** BG001

**Spread:** 13.5

**Value:** 46.1

#### Measurement

**Group ID:** BG002

**Spread:** 15.4

**Value:** 47.8

#### Measurement

**Group ID:** BG003

**Spread:** 15.2

**Value:** 50.0

#### Measurement

**Group ID:** BG004

**Spread:** 15.8

**Value:** 49.3

#### Measurement

**Group ID:** BG005

**Spread:** 15.4

**Value:** 48.7

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 20

#### Measurement

**Group ID:** BG001

**Value:** 25

#### Measurement

**Group ID:** BG002

**Value:** 21

#### Measurement

**Group ID:** BG003

**Value:** 25

#### Measurement

**Group ID:** BG004

**Value:** 23

#### Measurement

**Group ID:** BG005

**Value:** 114

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 28

#### Measurement

**Group ID:** BG001

**Value:** 23

#### Measurement

**Group ID:** BG002

**Value:** 27

#### Measurement

**Group ID:** BG003

**Value:** 23

#### Measurement

**Group ID:** BG004

**Value:** 25

#### Measurement

**Group ID:** BG005

**Value:** 126

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** mls9004@med.cornell.edu
**Organization:** Weill Cornell Medicine
**Phone:** 212-746-2953
**Title:** Michele Steinkamp
## Results Section - Outcome Measures Module
### Outcome Measure 1
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.96
- **Upper Limit:** 
- **Value:** 1.98
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.44
- **Upper Limit:** 
- **Value:** 1.18
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.54
- **Upper Limit:** 
- **Value:** 1.27
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0.59
- **Upper Limit:** 
- **Value:** 1.47
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 0.34
- **Upper Limit:** 
- **Value:** 1.13
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** 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.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 1 time during laryngoscopy
**Title:** 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.
**Type:** PRIMARY
**Unit of Measure:** units on a scale
##### Group
**Description:** Macintosh laryngoscope (control group/direct laryngoscopy) - current standard

Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation.
**ID:** OG000
**Title:** Macintosh Laryngoscope
##### Group
**Description:** Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy)

Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation.
**ID:** OG001
**Title:** Airtraq Optical Laryngoscope
##### Group
**Description:** Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy)

Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation
**ID:** OG002
**Title:** Storz DCI Video Laryngoscope
##### Group
**Description:** GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy)

GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation
**ID:** OG003
**Title:** GlideScope Video Laryngoscope
##### Group
**Description:** McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy)

McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation
**ID:** OG004
**Title:** McGRATH Video Laryngoscope
### Participant Flow Module
#### Group
**Description:** Macintosh laryngoscope (control group/direct laryngoscopy) - current standard

Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation.
**ID:** FG000
**Title:** Macintosh Laryngoscope
#### Group
**Description:** Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy)

Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation.
**ID:** FG001
**Title:** Airtraq Optical Laryngoscope
#### Group
**Description:** Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy)

Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation
**ID:** FG002
**Title:** Storz DCI Video Laryngoscope
#### Group
**Description:** GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy)

GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation
**ID:** FG003
**Title:** GlideScope Video Laryngoscope
#### Group
**Description:** McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy)

McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation
**ID:** FG004
**Title:** McGRATH Video Laryngoscope
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
###### Reason
**Group ID:** FG002
**Number of Subjects:** 3
###### Reason
**Group ID:** FG003
**Number of Subjects:** 2
###### Reason
**Group ID:** FG004
**Number of Subjects:** 3
##### Withdraw
**Type:** Failed Intubation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 1
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 48
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 48
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 48
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 48
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 48
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 45
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 45
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 45
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 45
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 45
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 3
**Has Results:** True