Comparison of Requirement of External Laryngeal Manipulation in Double Lumen Tube Insertion With McGrath Laryngoscope vs Macintosh Laryngoscope. A Randomized Control Trial

NCT06525779 | Completed

• 1 other identifier: IRB-19-15
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

For anatomical and physiological isolation of the lung, a specialized endotracheal tube known as the double lumen tube (DLT) is used. The introduction of DLT into anesthesia can be attributed to Carlen's who brought forth the concept in 1949. Since then the structure of DLT has continuously evolved. Simplistically speaking; the double lumen tube is a co-axial tube i.e. it contains two tubes put together, the tube with the shorter length stays in the trachea whereas the tube with the longer length enters the right or left main bronchus. If the proximal or tracheal cuff is inflated, air entry is permitted into both lungs. However, if the distal or the bronchial cuff is inflated, ventilation is directed into either lung depending on which lumen has been clamped, at the proximal end of the tube. Conventionally the DLTs were made of red rubber and were reusable but now they have been replaced by disposable plastic tubes which make it easy to view any secretions or blood. Also, since the plastic makes for a thin wall it allows the lumen of the tube to be large enough to allow airflow with minimal resistance. Larger lumens also allow passage of suction catheters and fiber-optic bronchoscope which serves the purpose of confirming correct position of the double lumen tube after placement. Tracheal intubation with a DLT may be facilitated by maneuvers such as external laryngeal manipulation (ELM). It is a simple technique which has been used by anesthetists since many years to enable intubation. Various types of video-laryngoscopes (VL) have been found to perform a crucial part in patients with difficult airways McGrath video-laryngoscope - a portable machine - provides a better laryngeal view compared to Macintosh laryngoscopy, involving cases of intubation involving patients with normal or difficult airways. Though the use of VL for DLT placement has been reported, such studies have fallen short of producing the desired quality of evidence that is required to make a clear determination in favor of one method over the other. It is suggested that more work is needed on this in order to create a wider, more reliable data pool.

Conditions

Intubation Complication

Keywords

Double Lumen Tube, External Laryngeal Manipulation, Macintosh, McGrath

Outcome Measures

Primary Outcomes (1)

• Requirement of External Laryngeal Manipulation

  Requirement of External Laryngeal Manipulation

  6 MONTHS

Study Arms (2)

Macintosh Laryngoscope Group

ACTIVE COMPARATOR

Patient undergoing intubation with direct laryngoscope using macintosh laryngoscope

Device: Use of macintosh laryngoscope

McGrath Laryngoscope Group

ACTIVE COMPARATOR

Patient undergoing intubation with video laryngoscope using mcGrath laryngoscope

Device: Use of mcGarth laryngoscope

Interventions

Use of macintosh laryngoscope DEVICE

The requirement of external laryngeal manipulation recorded in use of macintosh vs mcGrath laryngoscope in double lumen tube insertion

Macintosh Laryngoscope Group

Use of mcGarth laryngoscope DEVICE

Use of mcGarth laryngoscope

McGrath Laryngoscope Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA 1, 2, 3 patients
• years of age
• Patients undergoing surgery under general anesthesia requiring double lumen tube insertion (e.g. thoracic surgery, three stage esophagectomies)

You may not qualify if:

• Patient's refusal
• Patients with cervical spine instability/cervical myelopathy
• Patients requiring rapid sequence intubation
• Patients requiring additional intubation aids like bougie
• Patients having Wilson's Risk Score \> 5 (refer to annexure)
• Patients with loose teeth

Sponsors & Collaborators

• Shaukat Khanum Memorial Cancer Hospital & Research Centre: lead

Study Sites (1)

Shaukat Khanum Memorial Cancer Hospital and Research Center

Lahore, Punjab Province, 54000, Pakistan

Location

Study Design

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

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: January 25, 2021
• Primary Completion: July 25, 2021
• Study Completion: July 25, 2021
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: data is available to be shared
• Access Criteria: will be available once published

Locations

PA (1)