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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство C-MAC blade D video laryngoscope
  C-MAC blade D Video Laryngoscope is used for difficult intubation and for better glottic view
• Устройство Macintosh Laryngoscope
  Macintosh Laryngoscope is conventional laryngoscope used generally for intubations

Первичные конечные точки

• Time for intubation [Срок оценки: During induction of anesthesia, It will take 10 to 15 minutes]
• Heart Rate changes to laryngoscopy [Срок оценки: From enrollment till completion it will take approximately 24 hours]
• Blood pressure changes to laryngoscopy [Срок оценки: Time from enrolment to completion will be 24 hours]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Пакистан · 1 центр

• Shaheed Mohtarma Benazir Bhutto Institute of Trauma — Karachi

Публикации

• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06759038 · ERC-000146/SMBBIT/2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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