Two Video Laryngoscopes (Laringocel® and C-MAC®) for First-Attempt Intubation in Adults Undergoing Elective Surgery

Официальное название

Estimation of the Non-Inferiority of the Laringocel® Videolaryngoscope Compared With the C-MAC D-BLADE (Karl Storz®) for First-Attempt Intubation in Adult Patients Undergoing Elective Surgery

Обзор

This study will test two video laryngoscopes that help doctors place a breathing tube during surgery. A breathing tube is needed for people who receive general anesthesia so they can breathe safely. Video laryngoscopes use a small camera to give a better view of the throat and vocal cords, which may help the tube go in on the first try. The purpose of this research is to find out if a Colombian device called Laringocel® works as well as the widely used international device C-MAC D-Blade® (Karl Storz). If Laringocel® performs similarly, it could be a more affordable option for hospitals with limited resources. 252 adults (126 in each group) who need elective surgery at Alma Máter Hospital de Antioquia (Medellín, Colombia) will take part. Each participant will be randomly assigned, like flipping a coin, to have their breathing tube placed with either Laringocel® or C-MAC D-Blade®. Only trained anesthesiologists will perform the procedure. The study will look at: Main goal: how often the tube goes in correctly on the first attempt. Other goals: overall success within 3 attempts, how well the airway is seen, how long the intubation takes, how satisfied the doctor is with the device, and possible side effects such as sore throat, dental injury, or oral injury. Participation will not change the usual care people receive during anesthesia. Both devices are already approved for clinical use. Risks are the same as with any standard intubation, and participants will be checked after surgery for any problems. By comparing these two devices, researchers hope to learn if Laringocel® can provide safe and effective intubation at lower cost, improving access to advanced airway tools.

Вмешательства

• Устройство Laringocel® videolaryngoscope
  Orotracheal intubation performed with a hyperangulated Laringocel® videolaryngoscope by board-certified anesthesiologists who have completed a validated learning curve (CUSUM). Participants will undergo general anesthesia with adequate neuromuscular relaxation. The type and dose of anesthetic drugs will be determined by the attending anesthesiologist, ensuring at least an effective dose equivalent to ED95. If succinylcholine is used, intubation will be performed 45 seconds after administration;
• Устройство C-MAC® D-Blade videolaryngoscope
  Orotracheal intubation performed with a hyperangulated C-MAC® D-Blade videolaryngoscope (Karl Storz®) by board-certified anesthesiologists who have completed a validated learning curve (CUSUM). Participants will undergo general anesthesia with adequate neuromuscular relaxation. The type and dose of anesthetic drugs will be determined by the attending anesthesiologist, ensuring at least an effective dose equivalent to ED95. If succinylcholine is used, intubation will be performed 45 seconds afte

Первичные конечные точки

• First-attempt orotracheal intubation success [Срок оценки: During the intubation procedure (intraoperative, immediately after induction of anesthesia)]

Вторичные конечные точки (7)

• Overall orotracheal intubation success within three attempts [Срок оценки: During the intubation procedure (intraoperative, immediately after induction of anesthesia)]
• Percentage of Glottic Opening (POGO) score [Срок оценки: During the intubation procedure (intraoperative, immediately after induction of anesthesia)]
• Fremantle score [Срок оценки: During the intubation procedure (intraoperative, immediately after induction of anesthesia).]
• Intubation time [Срок оценки: During the intubation procedure (intraoperative, immediately after induction of anesthesia)]
• Operator satisfaction [Срок оценки: Immediately after the intubation procedure (intraoperative period)]
• Team situation awareness (SAGAT method) [Срок оценки: Immediately after the intubation procedure (intraoperative period)]
• Adverse events related to intubation [Срок оценки: One hour after extubation (post-anesthesia care unit or intensive care unit)]

Критерии участия

Критерии включения

• Patients 18 years of age or older
• Patients scheduled for elective surgery under general anesthesia
• Patients requiring single-lumen orotracheal intubation
• Patients compliant with the anesthetic indication and standard preoperative fasting requirements

Критерии исключения

• Patients with an anticipated difficult airway (more than two anatomical risk factors for difficult airway)
• Patient refusal to participate in the study via informed consent

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

Двойное слепое

Основная цель

Другое

Центры проведения

Колумбия · 1 центр

• Hospital Alma Máter de Antioquia — Medellín

Публикации

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• Mort TC. Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts. Anesth Analg. 2004 Aug;99(2):607-13, table of contents. doi: 10.1213/01.ANE.0000122825.04923.15. PMID 15271750
• Zhang J, Jiang W, Urdaneta F. Economic analysis of the use of video laryngoscopy versus direct laryngoscopy in the surgical setting. J Comp Eff Res. 2021 Jul;10(10):831-844. doi: 10.2217/cer-2021-0068. Epub 2021 Apr 27. PMID 33904779
• Heidegger T. Management of the Difficult Airway. N Engl J Med. 2021 May 13;384(19):1836-1847. doi: 10.1056/NEJMra1916801. No abstract available. PMID 33979490
• Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG; CONSORT Group. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA. 2012 Dec 26;308(24):2594-604. doi: 10.1001/jama.2012.87802. PMID 23268518
• Aziz MF, Abrons RO, Cattano D, Bayman EO, Swanson DE, Hagberg CA, Todd MM, Brambrink AM. First-Attempt Intubation Success of Video Laryngoscopy in Patients with Anticipated Difficult Direct Laryngoscopy: A Multicenter Randomized Controlled Trial Comparing the C-MAC D-Blade Versus the GlideScope in a Mixed Provider and Diverse Patient Population. Anesth Analg. 2016 Mar;122(3):740-750. doi: 10.1213/ PMID 26579847
• Hansel J, Rogers AM, Lewis SR, Cook TM, Smith AF. Videolaryngoscopy versus direct laryngoscopy for adults undergoing tracheal intubation. Cochrane Database Syst Rev. 2022 Apr 4;4(4):CD011136. doi: 10.1002/14651858.CD011136.pub3. PMID 35373840
• Apfelbaum JL, Hagberg CA, Connis RT, Abdelmalak BB, Agarkar M, Dutton RP, Fiadjoe JE, Greif R, Klock PA, Mercier D, Myatra SN, O'Sullivan EP, Rosenblatt WH, Sorbello M, Tung A. 2022 American Society of Anesthesiologists Practice Guidelines for Management of the Difficult Airway. Anesthesiology. 2022 Jan 1;136(1):31-81. doi: 10.1097/ALN.0000000000004002. PMID 34762729

Идентификаторы

NCT: NCT07239141 · IN29-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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