McGRATH MAC Video Laryngoscope

NCT ID: NCT02250521

Last Updated: 2018-11-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-06-30

Brief Summary

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This study was designed to determine the first attempt success rate of tracheal intubation with the McGRATH™ MAC laryngoscope using direct visualization in patients with known difficult airways, as well as exploring the possibility of identifying a particular direct Cormack-Lehane (C-L) grade view where indirect (video) visualization can be most beneficial during laryngoscopy and intubation.

Detailed Description

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Conditions

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Intubation; Difficult

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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McGrath Mac intubations

All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The liquid crystal display (LCD) monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.

Group Type EXPERIMENTAL

McGrath MAC enhanced direct laryngoscope

Intervention Type DEVICE

The McGRATH® MAC enhanced direct laryngoscope (EDL) combines the familiarity of direct laryngoscopy with an inline video camera for an enhanced view.

All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.

Interventions

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McGrath MAC enhanced direct laryngoscope

The McGRATH® MAC enhanced direct laryngoscope (EDL) combines the familiarity of direct laryngoscopy with an inline video camera for an enhanced view.

All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* BMI \< 50 kg/m2

Exclusion Criteria

* BMI ≥ 50 kg/m2
* emergency status
* cervical injury or pathology
* neck irradiation
* known difficult airway
* risk of gastric aspiration
* hemodynamic instability
* requiring rapid sequence intubation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic - MITG

INDUSTRY

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carin A Hagberg, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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HSC-MS-14-0365

Identifier Type: -

Identifier Source: org_study_id

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