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

Sponsor

Aga Khan University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05988736

Collaborator

(none)

Enrollment

Location

Arms

18.5

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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,

Rate of successful intubation at first attempt and
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.

Condition or Disease	Intervention/Treatment	Phase
Thoracic Diseases Thoracic Neoplasms Thoracic Empyema	Device: MaCintosh Laryngoscope (DL) Device: McGrath Laryngoscope (VL)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jun 15, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aga Khan University Hospital	Karachi	Sindh	Pakistan

Sponsors and Collaborators

Aga Khan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sadique Ali, Principal Investigator, Aga Khan University

ClinicalTrials.gov Identifier:

NCT05988736

Other Study ID Numbers:

2022-7215-21602

First Posted:

Aug 14, 2023

Last Update Posted:

Aug 14, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 14, 2023