McGRATH MAC Video Laryngoscope

NCT02250521 | Completed Results FDA Device

• 1 other identifier: HSC-MS-14-0365
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intubation; Difficult

Keywords

BMI < 50 kg/m2; Mallampatti class: III-IV; Reduced mouth opening < 4 cm; Neck circumference > 40 cm for females and > 43 cm for males; Thyromental distance < 6 cm; Ratio of the patient's height to thyromental distance ≥ 23.5; Sternomental distance < 12 cm

Outcome Measures

Primary Outcomes (1)

• Number of Participants Successfully Intubated on First Attempt With Use of Either a Direct or Indirect Laryngoscopic 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.

  after successful endotracheal tube placement

Secondary Outcomes (10)

• Glottic View With Direct Laryngoscopy

  at the time of laryngoscopy

• Glottic View With Indirect Laryngoscopy

  at the time of laryngoscopy

• Time for Direct View Laryngoscopy During the First Attempt

  at the time of laryngoscopy

• Time for Indirect View Laryngoscopy During the First Attempt

  at the time of laryngoscopy

• Time for Intubation

  at the time of laryngoscopy

Study Arms (1)

McGrath Mac intubations

EXPERIMENTAL

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.

Device: McGrath MAC enhanced direct laryngoscope

Interventions

McGrath MAC enhanced direct laryngoscope 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.

McGrath Mac intubations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI \< 50 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Medtronic - MITG: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Links

• Device information

Results Point of Contact

• Title: Carin A. Hagberg, MD
• Organization: The University of Texas Health Science Center at Houston

Carin.A.Hagberg@uth.tmc.edu

713-500-6200

Study Officials

• Carin A Hagberg, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: September 26, 2014
• Study Start: August 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 9, 2018
• Results First Posted: November 9, 2018

Record last verified: 2018-10

Locations

US (1)