McGRATH MAC Video Laryngoscope

Intubation; Difficult Clinical Trial

Official title:

McGRATH MAC Video Laryngoscope - To View or Not To View?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02250521
• Other study ID #: HSC-MS-14-0365
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: June 2016

Study information

• Verified date: October 2018
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• BMI < 50 kg/m2

• Two or more of the following inclusion criteria: Mallampati 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

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

Related Conditions & MeSH terms

• Intubation; Difficult

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Glottic View With Direct Laryngoscopy	Glottic view as described by Cormack and Lehane, scored as follows- Grade 1. Full view of glottis Grade 2a. Partial view of glottis Grade 2b. Arytenoids or posterior portion of cords just visible Grade 3. Only the epiglottis visible Grade 4. Neither epiglottis nor glottis visible	at the time of laryngoscopy
Secondary	Glottic View With Indirect Laryngoscopy	Glottic view as described by Cormack and Lehane (Samsoon GL, Young JR. Difficult tracheal intubation: A retrospective study. Anesthesia 1987; 42:487), scored as follows- Grade 1. Full view of glottis Grade 2a. Partial view of glottis Grade 2b. Arytenoids or posterior portion of cords just visible Grade 3. Only the epiglottis visible Grade 4. Neither epiglottis nor glottis visible	at the time of laryngoscopy
Secondary	Time for Direct View Laryngoscopy During the First Attempt	Time from mouth opening to best direct laryngoscopic view	at the time of laryngoscopy
Secondary	Time for Indirect View Laryngoscopy During the First Attempt	Time from mouth opening to best indirect laryngoscopic view	at the time of laryngoscopy
Secondary	Time for Intubation	Time for laryngoscopy (either direct or indirect) plus the time for endotracheal tube (ETT) cuff to pass vocal cords.	at the time of laryngoscopy
Secondary	Number of Intubation Attempts		at the time of intubation
Secondary	Number of Participants Who Received External Laryngeal Manipulation During the First Attempt		at the time of intubation
Secondary	Number of Participants on Whom Bougie (Introducer) Was Used to Facilitate Intubation on the First Attempt		at the time of intubation
Secondary	Subjective Ease of Laryngoscopy	The anesthesiologists rated the McGRATH™ MAC's ability in managing airways as "very easy," "easy," "slight resistance," "difficult," or "not possible." The difficulty of laryngoscopy was evaluated during the insertion and placement of the McGRATH™ MAC, from the patient's lips, into their oropharynx, until a glottic view was obtained.	at the time of laryngoscopy
Secondary	Subjective Ease of Intubation	The anesthesiologists rated the McGRATH™ MAC's ability in managing airways as "very easy," "easy," "slight resistance," "difficult," or "not possible." The difficulty of endotracheal tube (ETT) delivery (that is, intubation) was evaluated during the insertion of the ETT into the patient's mouth, until the ETT passed the vocal cords.	at the time of laryngoscopy

External Links

•   Device information