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

NCT07239141 | Recruiting

• 1 other identifier: IN29-2025
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Airway Management; Intubation, Endotracheal

Keywords

Videolaryngoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Overall orotracheal intubation success within three attempts

  During the intubation procedure (intraoperative, immediately after induction of anesthesia)

• Percentage of Glottic Opening (POGO) score

  During the intubation procedure (intraoperative, immediately after induction of anesthesia)

• Fremantle score

  During the intubation procedure (intraoperative, immediately after induction of anesthesia).

• Intubation time

  During the intubation procedure (intraoperative, immediately after induction of anesthesia)

• Operator satisfaction

  Immediately after the intubation procedure (intraoperative period)

Study Arms (2)

Laringocel

EXPERIMENTAL

Participants in this group will undergo orotracheal intubation using the Laringocel videolaryngoscope

Device: Laringocel® videolaryngoscope

C-MAC D-Blade

ACTIVE COMPARATOR

Participants in this group will undergo orotracheal intubation using the C-MAC D-Blade video laryngoscope (Karl Storz).

Device: C-MAC® D-Blade videolaryngoscope

Interventions

C-MAC® D-Blade videolaryngoscope DEVICE

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.

C-MAC D-Blade

Laringocel® videolaryngoscope DEVICE

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.

Laringocel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mario Zamudio: lead

Study Sites (1)

Hospital Alma Máter de Antioquia

Medellín, Antioquia, 050021, Colombia

RECRUITING

Related Publications (9)

• 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.

  PMID: 30231446 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 26579847 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 21447488 BACKGROUND

Central Study Contacts

Gabriel R Muñoz Miranda, MD, MSc (candidate)

CONTACT

+57 3187162895; gabrielr.munozm@udea.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: the person who generated the randomization sequence is independent from patient recruitment, intervention, and outcome assessment
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: University professor with a master's degree in clinical epidemiology

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 20, 2025
• Study Start: December 4, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• 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.
• 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.

Locations

CO (1)