C-MAC Blade D Video Vs Macintosh Laryngoscope for Double Lumen Tube Insertion (DLT)

December 27, 2024 updated by: Sidra Tahir, Shaheed Mohtarma Benazir Bhutto Institue of Trauma

Comparison Between C-MAC Blade D Video Laryngoscope and Macintosh Laryngoscope for Double Lumen Tube Insertion in Patients Undergoing Elective Thoracic Surgeries

The goal of this clinical trial is to know which type of laryngoscope is better for Double Lumen Tube (DLT) insertion, in participants undergoing elective thoracic surgeries.

The main question aim to answer is Is C-MAC blade D video laryngoscope better than Macintosh laryngoscope for DLT insertion in term of time taking for intubation and hemodynamic changes to laryngoscopy? Researchers are comparing two groups of participants

  • Participants in Group A are receiving intubation from C-MAC blade D video laryngoscope.
  • Participants in Group B are receiving intubations from Macintosh laryngoscope.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Double Lumen Tube (DLT) is a common airway management device, used to implement lung isolation technique during thoracic surgeries. Intubation of DLT is challenging because it is much larger in diameter and rotational insertion technique is associated with significant risk of prolong intubation, intubation failure, greater hemodynamic changes and airway trauma.

Objective of this study is to compare the outcome C-MAC blade D video laryngoscope and Macintosh laryngoscope for DLT insertion, in term of time taking for DLT intubation and hemodynamic changes to laryngoscopy.

This study is conducting at Department of Anesthesiology at SMBBIT, Pakistan. Data is collecting after taking approval from Ethical Review Committee and written informed consent from participants.

Participants are enrolling by primary investigator, day before surgery. All participants are undergoing simple randomization by lottery method.

During induction of aesthesia, time for intubation is noting from introduction of the laryngoscope blade till three complete capnograph cycles.

Participants have also been assessed for hemodynamic parameters {Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Pressure (MAP)} to intubation at 0 (Baseline), 1st Minute , 3rd Minute and 5th Minute after intubation.

After Completing data collection, Data analysis will be done by using SPSS version 26.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dr Sidra Javed Consultant Anaesthetist, MBBS, FCPS, pain Fellow
  • Phone Number: +93333 2474831
  • Email: sidra_dow@yahoo.com

Study Contact Backup

  • Name: Dr Mirza Shahzad Baig Consultant Anaesthetist, MBBS,MCPS, FCPS
  • Phone Number: +92334 6441539
  • Email: drshahzadbaig@hotmail.com

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • Recruiting
        • Shaheed Mohtarma Benazir Bhutto Institute of Trauma
        • Contact:
          • Sidra Tahir, MBBS, FCPS II trainee
        • Contact:
          • Sidra Javed Assistant Professor, MBBS, FCPS, Pain Fellow

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Mallampati 1 and 2.
  • ASA 1 and 2.
  • Patients who will be prepared for elective thoracic surgeries under general anesthesia.

Exclusion Criteria:

  • Pregnant Patients.
  • Patients with anticipated difficult airway.
  • Patients with limited neck extension.
  • Thyromental distance less than 6.5cm.
  • BMI greater than 35. (Weight in kilogram (kg) divided by height in meters squared)
  • Patients at a risk of aspiration.
  • Failure to intubate the patient after 3 attempts.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Video laryngoscope Group
Those participants who will randomly assigned for intubations with C-MAC Blade D Video laryngoscope are placed in Group A
Device: C-MAC blade D video laryngoscope
C-MAC blade D Video Laryngoscope is used for difficult intubation and for better glottic view
Active Comparator: Macintosh laryngoscope Group
Those participants who will randomly assigned for intubations with Macintosh Laryngoscope are placed in Group B
Device: Macintosh Laryngoscope
Macintosh Laryngoscope is conventional laryngoscope used generally for intubations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time for intubation
Time Frame: During induction of anesthesia, It will take 10 to 15 minutes
1st outcome is time for intubation time for intubation will be noted during intubation of Double Lumen Tube. Time start from introduction of laryngoscope blade till three complete capnograph cycles.
During induction of anesthesia, It will take 10 to 15 minutes
Heart Rate changes to laryngoscopy
Time Frame: From enrollment till completion it will take approximately 24 hours
Heart Rate of a patient will be noted before induction of Anaesthesia as baseline heart rate and will be labelled as 0. Then at 1 minute, at 3 minutes and at 5 minutes after intubation, and labelled as 1 ,3 & 5.
From enrollment till completion it will take approximately 24 hours
Blood pressure changes to laryngoscopy
Time Frame: Time from enrolment to completion will be 24 hours
Changes of blood pressure to laryngoscopy as Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DPB) and Mean Arterial Pressure (MAP) will be noted before induction of anesthesia as baseline and labelled as 0. Then at 1 minute, 3 minutes and 5 minutes after intubation and labelled as 1, 3 and 5.
Time from enrolment to completion will be 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaheed Mohtarma Benazir Bhutto Institue of Trauma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2024

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

December 11, 2024

First Submitted That Met QC Criteria

December 27, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 27, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • ERC-000146/SMBBIT/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient Confidentiality: Sharing IPD could compromise patient confidentiality and anonymity Informed Consent: Participants are not providing informed consent for their data to be shared and it could raise ethical concerns.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Elective Thoracic Surgery

Clinical Trials on C-MAC blade D video laryngoscope

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe