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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Airway Management; Intubation, Endotracheal
• Intervention / Treatment: Device: Laringocel® videolaryngoscope; Device: C-MAC® D-Blade videolaryngoscope

• Study Type: Interventional
• Enrollment (Estimated): 252
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabriel R Muñoz Miranda, MD, MSc (candidate); Phone Number: +57 3187162895; Email: gabrielr.munozm@udea.edu.co

Study Locations

• Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia, 050021
      • Recruiting
      • Hospital Alma Mater de Antioquia
      • Contact: Hospital Alma Máter de Antioquia; Phone Number: Option 1 31004 6049595; Email: investigacion@almamater.hospital
      • Principal Investigator: Gabriel R Muñoz Miranda, MD
      • Sub-Investigator: Mario A Zamudio Burbano, MD, Specialist, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laringocel; Participants in this group will undergo orotracheal intubation using the Laringocel videolaryngoscope	Device: 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.
Active Comparator: C-MAC D-Blade; Participants in this group will undergo orotracheal intubation using the C-MAC D-Blade video laryngoscope (Karl Storz).	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First-attempt orotracheal intubation success	Proportion of participants with successful tracheal intubation on the first attempt, defined as correct placement of the endotracheal tube confirmed by continuous capnography. A successful attempt is one in which the videolaryngoscope is introduced and removed only once, without requiring a second attempt, device change, or external assistance.	During the intubation procedure (intraoperative, immediately after induction of anesthesia)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall orotracheal intubation success within three attempts	Proportion of participants with successful tracheal intubation within a maximum of three attempts using the assigned videolaryngoscope, defined as correct tube placement confirmed by continuous capnography.	During the intubation procedure (intraoperative, immediately after induction of anesthesia)
Percentage of Glottic Opening (POGO) score	Continuous measure from 0 to 100% estimating the visible portion of the vocal cords during videolaryngoscopy. Higher values indicate a better glottic view. Mean POGO scores will be compared between intervention groups.	During the intubation procedure (intraoperative, immediately after induction of anesthesia)
Intubation time	Time in seconds from insertion of the videolaryngoscope into the mouth until confirmation of successful tracheal tube placement by capnography.	During the intubation procedure (intraoperative, immediately after induction of anesthesia)
Operator satisfaction	Mean score of four items on a 5-point Likert scale evaluating technical ease, physical comfort, overall satisfaction, and willingness to reuse the device (1 = very satisfied, 5 = not satisfied).	Immediately after the intubation procedure (intraoperative period)
Team situation awareness (SAGAT method)	Assessed by an external observer using the Situation Awareness Global Assessment Technique (SAGAT). Binary responses to three questions representing perception, comprehension, and projection of the situation.	Immediately after the intubation procedure (intraoperative period)
Adverse events related to intubation	Proportion of participants presenting sore throat, dental injury, or visible mucosal/oropharyngeal lesions after extubation, assessed by direct examination and participant report.	One hour after extubation (post-anesthesia care unit or intensive care unit)
Fremantle score	Ordinal scale combining the best laryngeal view obtained (Full, Partial, None) and ease of intubation (1 = easy, 2 = modified, 3 = impossible). Lower scores indicate easier intubation.	During the intubation procedure (intraoperative, immediately after induction of anesthesia).

Collaborators and Investigators

• Sponsor: Mario Zamudio

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: November 15, 2025
• First Submitted That Met QC Criteria: November 15, 2025
• First Posted (Estimated): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Videolaryngoscopy
• Other Study ID Numbers: IN29-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data that underlie the published results will be shared. This will include demographic data, airway characteristics, and outcome variables used in the analyses. A data dictionary will accompany the dataset.
• IPD Sharing Time Frame: The de-identified individual participant data and supporting documentation will be available after the study is completed and the main results are published. Data will remain accessible for 5 years. After this period, requests will be evaluated on a case-by-case basis, depending on data storage conditions and the status of ethical approval.
• IPD Sharing Access Criteria: Access will be granted to qualified researchers with methodologically sound proposals for secondary analyses that align with the study objectives or advance research in airway management. Proposals will be reviewed by the Principal Investigator and the Institutional Ethics Committee of Hospital Alma Máter de Antioquia. Approved applicants must sign a data access agreement outlining confidentiality, data security, and publication terms. Requests should be sent to gabriel.munoz@udea.edu.co.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No