McGrath vs. C-MAC Video Laryngoscopy Comparison in Endotracheal Tube Insertion

Effectiveness Comparison Between McGrath and C-MAC Video Laryngoscope in Endotracheal Tube Insertion

Tracheal intubation is commonly performed using a standard Macintosh blade, but recently there has been advanced technology using video laryngoscopy (VL).In this modern era, there are various types of available VL to make it easier for anesthesiologists to perform intubation, especially in patients with difficult airway anatomy.

Various studies showed different results regarding the effectiveness of both C-MAC® and McGrath®, by assessing the comparison of the effectiveness, valuable information will be obtained for further consideration by experts in choosing the best tools in the future.

Study Overview

• Status: Completed
• Conditions: Intubation; Difficult or Failed
• Intervention / Treatment: Device: Endotracheal intubation

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Bali
    • Denpasar, Bali, Indonesia, 80114
      • Sanglah General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Elective surgery patients without neck and face trauma
2. Undergo surgery requiring general anesthesia with endotracheal intubation
3. Patients with physical status ASA I-III
4. Patients aged 18-65 years
5. Nutritional status (BMI < 35 Kg/m2)

Exclusion Criteria:

1. Patients refusal to be included in the study
2. Patients with cervical spine instability
3. Anatomical and structural abnormalities of the maxillary teeth
4. Thyromental distance <6 cm and inter-incisor distance <3.5 cm
5. History of difficult intubation
6. LEMON criteria ≥ 3

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: McGrath Video Laryngoscope	Device: Endotracheal intubation; Endotracheal intubation using either McGrath or C-MAC video laryngoscopy
Active Comparator: C-MAC Video Laryngoscope	Device: Endotracheal intubation; Endotracheal intubation using either McGrath or C-MAC video laryngoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation time	Time required to perform intubation until endotracheal tube is properly positioned	From first intubation attempt until successful intubation, an average of one minute
Ease of intubation	Difficulty level of intubation, scores 1-2, 1=effortless, 2=difficult	From first intubation attempt until successful intubation, an average of two minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of intubation attempts	The number of times required for a successful intubation	From first intubation attempt until successful intubation, an average of one minute
Glottic visualization	Visualization of glottic assessed by the POGO (Percentage of Glottis Opening) score, 1=best, 4=worst	During first intubation attempt, an average of 30 seconds
Complications of intubation	Includes orotracheal trauma, presence of blood in the blades, laryngospasm, bradycardia	From first intubation attempt until successful intubation, an average of one minute

Collaborators and Investigators

• Sponsor: Udayana University
• Investigators: Study Director: Jhoni P Pasaribu, Udayana University; Principal Investigator: Christopher Ryalino, Udayana University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): October 14, 2021

Study Registration Dates

• First Submitted: June 10, 2021
• First Submitted That Met QC Criteria: June 15, 2021
• First Posted (Actual): June 23, 2021

Study Record Updates

• Last Update Posted (Actual): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 18, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: UNUD-CTR-FK110621-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No