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Comparison Study in Adult Surgical Patients of 5 Airway Devices

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00602979
Enrollment
240
Registered
2008-01-28
Start date
2008-04-30
Completion date
2011-07-31
Last updated
2017-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation, Laryngoscopy

Keywords

endotracheal intubation, intubation, laryngoscopy, laryngoscope, surgery

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.

Interventions

DEVICEMacintosh laryngoscope

Used during laryngoscopy to facilitate intubation.

DEVICEAirtraq® Optical Laryngoscope

Used during laryngoscopy to facilitate intubation.

DEVICEStorz DCI Video Laryngoscope®

Used during laryngoscopy to facilitate intubation

Used during laryngoscopy to facilitate intubation

DEVICEMcGRATH® Video Laryngoscope

Used during laryngoscopy to facilitate intubation

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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 laryngoscopyPercentage 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.

Participant flow

Participants by arm

ArmCount
Macintosh Laryngoscope
Macintosh laryngoscope (control group/direct laryngoscopy) - current standard Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation.
48
Airtraq Optical Laryngoscope
Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy) Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation.
48
Storz DCI Video Laryngoscope
Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy) Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation
48
GlideScope Video Laryngoscope
GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy) GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation
48
McGRATH Video Laryngoscope
McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy) McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation
48
Total240

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004
Overall StudyFailed Intubation01010
Overall StudyLost to Follow-up32323

Baseline characteristics

CharacteristicTotalMacintosh LaryngoscopeAirtraq Optical LaryngoscopeStorz DCI Video LaryngoscopeGlideScope Video LaryngoscopeMcGRATH Video Laryngoscope
Age, Continuous48.7 years
STANDARD_DEVIATION 15.4
50.3 years
STANDARD_DEVIATION 16.9
46.1 years
STANDARD_DEVIATION 13.5
47.8 years
STANDARD_DEVIATION 15.4
50.0 years
STANDARD_DEVIATION 15.2
49.3 years
STANDARD_DEVIATION 15.8
Sex: Female, Male
Female
114 Participants20 Participants25 Participants21 Participants25 Participants23 Participants
Sex: Female, Male
Male
126 Participants28 Participants23 Participants27 Participants23 Participants25 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
0 / 480 / 480 / 480 / 480 / 48
other
Total, other adverse events
0 / 480 / 480 / 480 / 481 / 48
serious
Total, serious adverse events
2 / 480 / 480 / 480 / 481 / 48

Outcome results

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.

Time frame: 1 time during laryngoscopy

ArmMeasureValue (MEAN)Dispersion
Macintosh LaryngoscopePercentage 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 units on a scaleStandard Deviation 1.96
Airtraq Optical LaryngoscopePercentage 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.1.18 units on a scaleStandard Deviation 0.44
Storz DCI Video LaryngoscopePercentage 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.1.27 units on a scaleStandard Deviation 0.54
GlideScope Video LaryngoscopePercentage 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.1.47 units on a scaleStandard Deviation 0.59
McGRATH Video LaryngoscopePercentage 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.1.13 units on a scaleStandard Deviation 0.34

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026