Two Video Laryngoscopes (Laringocel® and C-MAC®) for First-Attempt Intubation in Adults Undergoing Elective Surgery
NCT ID: NCT07239141
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
252 participants
INTERVENTIONAL
2025-12-04
2026-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Laringocel
Participants in this group will undergo orotracheal intubation using the Laringocel videolaryngoscope
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; for cisatracurium, after 4 minutes; and for vecuronium or rocuronium, after 2 minutes.
C-MAC D-Blade
Participants in this group will undergo orotracheal intubation using the C-MAC D-Blade video laryngoscope (Karl Storz).
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 after administration; for cisatracurium, after 4 minutes; and for vecuronium or rocuronium, after 2 minutes.
Interventions
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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; for cisatracurium, after 4 minutes; and for vecuronium or rocuronium, after 2 minutes.
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 after administration; for cisatracurium, after 4 minutes; and for vecuronium or rocuronium, after 2 minutes.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Patient refusal to participate in the study via informed consent
18 Years
ALL
Yes
Sponsors
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Mario Zamudio
OTHER
Responsible Party
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Mario Zamudio
University professor with a master's degree in clinical epidemiology
Locations
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Hospital Alma Máter de Antioquia
Medellín, Antioquia, Colombia
Countries
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Central Contacts
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Facility Contacts
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References
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Sotres-Ramos D, Almendra-Arao F, Anguiano-Mondragon E. A New Method for the Comparison of Powers of Noninferiority Exact Tests for the Difference of Proportions. Ther Innov Regul Sci. 2014 Sep;48(5):592-600. doi: 10.1177/2168479014523005.
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.
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.
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.
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.
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/ANE.0000000000001084.
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.
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.
Cook TM, Woodall N, Frerk C; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia. Br J Anaesth. 2011 May;106(5):617-31. doi: 10.1093/bja/aer058. Epub 2011 Mar 29.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IN29-2025
Identifier Type: -
Identifier Source: org_study_id
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