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

NCT06759038 | Recruiting DMC

• 1 other identifier: ERC-000146/SMBBIT/2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Video Laryngoscope; Double Lumen Tube Intubation; Elective Thoracic Surgery

Outcome Measures

Primary Outcomes (3)

• Time for intubation

  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

  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

  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

Study Arms (2)

Video laryngoscope Group

EXPERIMENTAL

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

Macintosh laryngoscope Group

ACTIVE COMPARATOR

Those participants who will randomly assigned for intubations with Macintosh Laryngoscope are placed in Group B

Device: Macintosh Laryngoscope

Interventions

C-MAC blade D video laryngoscope DEVICE

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

Video laryngoscope Group

Macintosh Laryngoscope DEVICE

Macintosh Laryngoscope is conventional laryngoscope used generally for intubations

Macintosh laryngoscope Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shaheed Mohtarma Benazir Bhutto Institue of Trauma: lead

Study Sites (1)

Shaheed Mohtarma Benazir Bhutto Institute of Trauma

Karachi, Sindh, Pakistan

RECRUITING

Related Publications (4)

• Smereka J, Ladny JR, Naylor A, Ruetzler K, Szarpak L. C-MAC compared with direct laryngoscopy for intubation in patients with cervical spine immobilization: A manikin trial. Am J Emerg Med. 2017 Aug;35(8):1142-1146. doi: 10.1016/j.ajem.2017.03.030. Epub 2017 Mar 16.

  PMID: 28341185 BACKGROUND

• Kim YS, Song J, Lim BG, Lee IO, Won YJ. Different classes of videoscopes and direct laryngoscopes for double-lumen tube intubation in thoracic surgery: A systematic review and network meta-analysis. PLoS One. 2020 Aug 28;15(8):e0238060. doi: 10.1371/journal.pone.0238060. eCollection 2020.

  PMID: 32857788 BACKGROUND

• Liu HH, Dong F, Liu JY, Wei JQ, Huang YK, Wang Y, Zhou T, Ma WH. The use of ETView endotracheal tube for surveillance after tube positioning in patients undergoing lobectomy, randomized trial. Medicine (Baltimore). 2018 Dec;97(49):e13170. doi: 10.1097/MD.0000000000013170.

  PMID: 30544376 BACKGROUND

• Tao D, Zhang G, Zheng X, Wang X, Gao G, Yang Z, Lin Y, Lu L. Feasibility study of intubation in lateral position using Viva-sight double-lumen tube combined with video laryngoscope in patients undergoing pulmonary lobectomy. Asian J Surg. 2024 Jan;47(1):373-379. doi: 10.1016/j.asjsur.2023.08.199. Epub 2023 Sep 9.

  PMID: 37696694 BACKGROUND

Central Study Contacts

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

CONTACT

+93333 2474831; sidra_dow@yahoo.com

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

CONTACT

+92334 6441539; drshahzadbaig@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only participant is unaware that which type of intervention is using over him.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: There are two groups of participants Group A and Group B. Allocation of participants in each group is done by basic randomization.

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: January 6, 2025
• Study Start: December 3, 2024
• Primary Completion: February 28, 2025
• Study Completion: March 1, 2025
• Last Updated: January 6, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)