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

NCT04936516 | Completed

• 1 other identifier: UNUD-CTR-FK110621-001
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intubation; Difficult or Failed

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Number of intubation attempts

  From first intubation attempt until successful intubation, an average of one minute

• Glottic visualization

  During first intubation attempt, an average of 30 seconds

• Complications of intubation

  From first intubation attempt until successful intubation, an average of one minute

Study Arms (2)

McGrath Video Laryngoscope

ACTIVE COMPARATOR

Device: Endotracheal intubation

C-MAC Video Laryngoscope

ACTIVE COMPARATOR

Device: Endotracheal intubation

Interventions

Endotracheal intubation DEVICE

Endotracheal intubation using either McGrath or C-MAC video laryngoscopy

C-MAC Video Laryngoscope; McGrath Video Laryngoscope

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Udayana University: lead

Study Sites (1)

Sanglah General Hospital

Denpasar, Bali, 80114, Indonesia

Location

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques

Study Officials

• Tjokorda GA Senapathi, Dr

  Udayana University

  STUDY CHAIR

• Jhoni P Pasaribu

  Udayana University

  STUDY DIRECTOR

• Christopher Ryalino

  Udayana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 23, 2021
• Study Start: August 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: October 14, 2021
• Last Updated: October 19, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)