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NCT Number: NCT06759038

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shaheed Mohtarma Benazir Bhutto Institute of Trauma

Karachi, Sindh, Pakistan

Location status: Recruiting

Location contact

Sidra Javed Assistant Professor, MBBS, FCPS, Pain Fellow

CONTACT

Sidra Tahir, MBBS, FCPS II trainee

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

C-MAC blade D video laryngoscope

Device

C-MAC blade D Video Laryngoscope is used for difficult intubation and for better glottic view

Macintosh laryngoscope

Device

Macintosh Laryngoscope is conventional laryngoscope used generally for intubations

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Mirza Shahzad Baig Consultant Anaesthetist, MBBS,MCPS, FCPS

CONTACT

[email protected]

+92334 6441539

Dr Sidra Javed Consultant Anaesthetist, MBBS, FCPS, pain Fellow

CONTACT

[email protected]

+93333 2474831

Sponsors and collaborators

Lead sponsor

Shaheed Mohtarma Benazir Bhutto Institue of Trauma

Other

Registry information

Official study title

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

Acronym: DLT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 6, 2025
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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