Comparison Study in Adult Surgical Patients of 5 Airway Devices

NCT ID: NCT00602979

Last Updated: 2017-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2011-07-31

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

Laryngoscopy; Intubation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Macintosh laryngoscope

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

Group Type: OTHER

Macintosh laryngoscope

Intervention Type: DEVICE

Used during laryngoscopy to facilitate intubation.

Airtraq Optical Laryngoscope

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

Group Type: OTHER

Airtraq® Optical Laryngoscope

Intervention Type: DEVICE

Used during laryngoscopy to facilitate intubation.

Storz DCI Video Laryngoscope

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

Group Type: OTHER

Storz DCI Video Laryngoscope®

Intervention Type: DEVICE

Used during laryngoscopy to facilitate intubation

GlideScope Video Laryngoscope

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

Group Type: OTHER

GlideScope® Video Laryngoscope

Intervention Type: DEVICE

Used during laryngoscopy to facilitate intubation

McGRATH Video Laryngoscope

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

Group Type: OTHER

McGRATH® Video Laryngoscope

Intervention Type: DEVICE

Used during laryngoscopy to facilitate intubation

Interventions

Macintosh laryngoscope

Used during laryngoscopy to facilitate intubation.

Intervention Type: DEVICE

Airtraq® Optical Laryngoscope

Used during laryngoscopy to facilitate intubation.

Intervention Type: DEVICE

Storz DCI Video Laryngoscope®

Used during laryngoscopy to facilitate intubation

Intervention Type: DEVICE

GlideScope® Video Laryngoscope

Used during laryngoscopy to facilitate intubation

Intervention Type: DEVICE

McGRATH® Video Laryngoscope

Used during laryngoscopy to facilitate intubation

Intervention Type: DEVICE

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 Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Systems Corporation

INDUSTRY

Sponsor Role: collaborator

KARL STORZ Endoscopy-America, Inc.

INDUSTRY

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jon Samuels, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

References

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.

Reference Type: BACKGROUND

PMID: 10671848 (View on PubMed)

Other Identifiers

0710009433

Identifier Type: -

Identifier Source: org_study_id