Comparison Between McGrath and Macintosh Laryngoscopes for DLT Intubation in Thoracic Surgery Patients.

Comparison Between McGrath and Macintosh Laryngoscopes for Double-lumen Tube Intubation in Patients Undergoing Thoracic Surgery, A Prospective Randomized Controlled Trial

The goal of this RCT is to compare outcome with McGrath vs Macintosh laryngoscopes among patients undergoing thoracic surgery. The main questions it aims to answer are,

1. Rate of successful intubation at first attempt and
2. Time for intubation required with each device. Participants are required to sign the informed consent for, they will be placed in two groups, Group A: Macintosh (DL) Group B: McGrath (VL) Researchers will compare in Group A: Macintosh (DL) and Group B: McGrath (VL) the differences in rate of successful intubation at first attempt and time for intubation required with each device.

Study Overview

• Status: Recruiting
• Conditions: Thoracic Neoplasms; Thoracic Diseases; Thoracic Empyema
• Intervention / Treatment: Device: MaCintosh Laryngoscope (DL); Device: McGrath Laryngoscope (VL)

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: sadique Wadho, MBBS; Phone Number: +923322792932; Email: sadique.ali@aku.edu
• Study Contact Backup: Name: Khalid Samad, MBBS, FCPS; Phone Number: +923343311603; Email: khalid.samad@aku.edu

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Recruiting
      • Aga Khan University Hospital
      • Contact: sadique Wadho, MBBS; Phone Number: +923322792932; Email: sadique.ali@aku.edu
      • Contact: Khalid Samad, MBBS. FCPS; Phone Number: +923343311603; Email: khalid.samad@aku.edu
      • Principal Investigator: sadique Wadho, MBBS
      • Principal Investigator: Khalid Samad, MBBS, FCPS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18-65 years
• American Society of Anaesthesiologists physical status (ASA) I, II, III
• Elective thoracic surgery patients, requiring one lung ventilation.

Exclusion Criteria:

• Patients requiring rapid sequence induction
• Patients with a structural problem in the airway on chest radiography
• History of difficult intubation

• Planned tracheostomy \ the presence of a tracheostomy

  • Patients with a BMI >35 kg\m2. Who at risk of regurgitation\ Aspiration
  • Anticipated Difficult Airway (Mallampati IV)
  • Pre-existing sore throat or hoarseness, or recent respiratory infection (<15 days)

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
Experimental: Group A	Device: MaCintosh Laryngoscope (DL); A conventional Laryngoscope. It is battery powered, with a detachable MaCintosh blade that contains a light source.
Active Comparator: Group B	Device: McGrath Laryngoscope (VL); A video Laryngoscope that has a high-resolution video camera, and a light source at the cone end of the blade allowing for direct and indirect viewing of the glottis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time required for correct placement of the Double Lumen Tube (DLT).	Time will be measured in seconds during laryngoscopy while placement of Double Lumen Tube (DLT) until appearance of end tidal carbon dioxide on capnograph.	During intervention time period
Successful Intubation at first attempt.	The number of times the laryngoscope will be inserted.	immediately after Intervention.

Collaborators and Investigators

• Sponsor: Aga Khan University

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: July 27, 2023
• First Submitted That Met QC Criteria: August 9, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Inflammation; Pleural Diseases; Suppuration; Aneurysm; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Thoracic Diseases; Thoracic Neoplasms; Empyema; Empyema, Pleural; Aortic Dissection
• Other Study ID Numbers: 2022-7215-21602

Drug and device information, study documents

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