Clinical trial NCT02250521: McGRATH MAC Video Laryngoscope
Official title: McGRATH MAC Video Laryngoscope - To View or Not To View?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Medtronic - MITG
First posted: 2014-09-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Successfully Intubated on First Attempt With Use of Either a Direct or Indirect Laryngoscopic View
timeFrame: after successful endotracheal tube placement
Secondary outcomes:
measure: Glottic View With Direct Laryngoscopy
timeFrame: at the time of laryngoscopy
measure: Glottic View With Indirect Laryngoscopy
timeFrame: at the time of laryngoscopy
measure: Time for Direct View Laryngoscopy During the First Attempt
timeFrame: at the time of laryngoscopy
measure: Time for Indirect View Laryngoscopy During the First Attempt
timeFrame: at the time of laryngoscopy
measure: Time for Intubation
timeFrame: at the time of laryngoscopy
measure: Number of Intubation Attempts
timeFrame: at the time of intubation
measure: Number of Participants Who Received External Laryngeal Manipulation During the First Attempt
timeFrame: at the time of intubation
measure: Number of Participants on Whom Bougie (Introducer) Was Used to Facilitate Intubation on the First Attempt
timeFrame: at the time of intubation
measure: Subjective Ease of Laryngoscopy
timeFrame: at the time of laryngoscopy
measure: Subjective Ease of Intubation
timeFrame: at the time of laryngoscopy
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Carin A Hagberg, MD
role: PRINCIPAL_INVESTIGATOR
References: