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

Not Applicable

Recruiting

• Conditions: Video Laryngoscope; Double Lumen Tube Intubation; Elective Thoracic Surgery

• Registration Number: NCT06759038
• Lead Sponsor: Shaheed Mohtarma Benazir Bhutto Institue of Trauma

Brief Summary

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.

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 Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-03
• Study First Submitted: 2024-12-11
• Study First Submitted QC: 2024-12-27
• Last Update Submitted: 2024-12-27
• Study First Posted: 2025-01-06
• Last Update Posted: 2025-01-06
• Primary Completion: 2025-02-28
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time for intubation	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.
Heart Rate changes to laryngoscopy	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.
Blood pressure changes to laryngoscopy	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.

Trial Locations

Locations (1)

Shaheed Mohtarma Benazir Bhutto Institute of Trauma; 🇵🇰 Karachi, Sindh, Pakistan