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

Primary Purpose

Thoracic Diseases, Thoracic Neoplasms, Thoracic Empyema

Status

Recruiting

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

MaCintosh Laryngoscope (DL)

McGrath Laryngoscope (VL)

About this trial

This is an interventional other trial for Thoracic Diseases

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Aga Khan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

Outcomes

Primary Outcome Measures

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.

Successful Intubation at first attempt.

The number of times the laryngoscope will be inserted.

Secondary Outcome Measures

Full Information

NCT ID

NCT05988736

First Posted

July 27, 2023

Last Updated

August 9, 2023

Sponsor

Aga Khan University

1. Study Identification

Unique Protocol Identification Number

NCT05988736

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 15, 2022 (Actual)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aga Khan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thoracic Diseases, Thoracic Neoplasms, Thoracic Empyema

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Title

Group B

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

MaCintosh Laryngoscope (DL)

Intervention Description

A conventional Laryngoscope. It is battery powered, with a detachable MaCintosh blade that contains a light source.

Intervention Type

Device

Intervention Name(s)

McGrath Laryngoscope (VL)

Intervention Description

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

Primary Outcome Measure Information:

Title

Time required for correct placement of the Double Lumen Tube (DLT).

Description

Time will be measured in seconds during laryngoscopy while placement of Double Lumen Tube (DLT) until appearance of end tidal carbon dioxide on capnograph.

Time Frame

During intervention time period

Title

Successful Intubation at first attempt.

Description

The number of times the laryngoscope will be inserted.

Time Frame

immediately after Intervention.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

sadique Wadho, MBBS

Phone

+923322792932

sadique.ali@aku.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Khalid Samad, MBBS, FCPS

Phone

+923343311603

khalid.samad@aku.edu

Facility Information:

Facility Name

Aga Khan University Hospital

City

Karachi

State/Province

Sindh

Country

Pakistan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

sadique Wadho, MBBS

Phone

+923322792932

sadique.ali@aku.edu

First Name & Middle Initial & Last Name & Degree

Khalid Samad, MBBS. FCPS

Phone

+923343311603

khalid.samad@aku.edu

First Name & Middle Initial & Last Name & Degree

sadique Wadho, MBBS

First Name & Middle Initial & Last Name & Degree

Khalid Samad, MBBS, FCPS

12. IPD Sharing Statement

Learn more about this trial

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

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