Airway ManagementLARINGOCOLNCT07239141
Two Video Laryngoscopes (Laringocel® and C-MAC®) for First-Attempt Intubation in Adults Undergoing Elective Surgery
A study testing Laringocel® videolaryngoscope and C-MAC® D-Blade videolaryngoscope in people with Airway Management and Intubation, Endotracheal, run by Mario Zamudio at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Airway Management, Intubation, Endotracheal
- What is being tested?
- Laringocel® videolaryngoscope and C-MAC® D-Blade videolaryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteColombia
- Study dates
- 4 Dec 2025to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
Hospital Alma Máter de Antioquia
Medellín, Antioquia, 050021
Hospital Alma Máter de Antioquia, 6049595 ext. Option 1 31004, investigacion@almamater.hospital
Gabriel R Muñoz Miranda, MD
About this study
Official title: 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.
Read more
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
- Being tested
- Laringocel® videolaryngoscope, C-MAC® D-Blade videolaryngoscope
- Keywords
- Videolaryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laringocel® videolaryngoscopeDevice
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 videolaryngoscopeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Laringocel | Experimental | Participants in this group will undergo orotracheal intubation using the Laringocel videolaryngoscope Receives: 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). Receives: Device: C-MAC® D-Blade videolaryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the intubation procedure (intraoperative, immediately after induction of anesthesia)
Secondary outcomes (7)
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.
Measured: 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.
Measured: During the intubation procedure (intraoperative, immediately after induction of anesthesia)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: One hour after extubation (post-anesthesia care unit or intensive care unit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start4 Dec 2025
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mario Zamudio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mario Zamudio, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239141
- Sponsor's protocol ID
- IN29-2025
- Acronym
- LARINGOCOL
- Status last verified
- Dec 2025
- First submitted
- 15 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 30231446Mort 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.
PubMed 15271750Zhang 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.
PubMed 33904779Heidegger T. Management of the Difficult Airway. N Engl J Med. 2021 May 13;384(19):1836-1847. doi: 10.1056/NEJMra1916801. No abstract available.
PubMed 33979490Piaggio 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.
PubMed 23268518Aziz 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.
PubMed 26579847Hansel 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.
PubMed 35373840Apfelbaum 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.
PubMed 34762729Cook 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.
PubMed 21447488
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07239141
- Acronym / sponsor ID
- LARINGOCOL / IN29-2025
- Conditions
- Airway Management, Intubation, Endotracheal
- Keywords
- Videolaryngoscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Mario ZamudioUniversity, hospital or other
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laringocel | Experimental | Device: Laringocel® videolaryngoscopeParticipants in this group will undergo orotracheal intubation using the Laringocel videolaryngoscope |
| C-MAC D-Blade | Active comparator | Device: C-MAC® D-Blade videolaryngoscopeParticipants in this group will undergo orotracheal intubation using the C-MAC D-Blade video laryngoscope (Karl Storz). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laringocel® videolaryngoscopeOrotracheal 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. | Device | Laringocel |
| C-MAC® D-Blade videolaryngoscopeOrotracheal 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. | Device | C-MAC D-Blade |
Primary outcome
First-attempt orotracheal intubation success
Time frame: During the intubation procedure (intraoperative, immediately after induction of anesthesia)
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.
7 secondary outcomes
Overall orotracheal intubation success within three attempts
Time frame: During the intubation procedure (intraoperative, immediately after induction of anesthesia)
Percentage of Glottic Opening (POGO) score
Time frame: During the intubation procedure (intraoperative, immediately after induction of anesthesia)
Fremantle score
Time frame: During the intubation procedure (intraoperative, immediately after induction of anesthesia).
Intubation time
Time frame: During the intubation procedure (intraoperative, immediately after induction of anesthesia)
Operator satisfaction
Time frame: Immediately after the intubation procedure (intraoperative period)
Team situation awareness (SAGAT method)
Time frame: Immediately after the intubation procedure (intraoperative period)
Adverse events related to intubation
Time frame: One hour after extubation (post-anesthesia care unit or intensive care unit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Background: PubMed 30231446Sotres-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.
- Background: PubMed 15271750Mort 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.
- Background: PubMed 33904779Zhang 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.
- Background: PubMed 33979490Heidegger T. Management of the Difficult Airway. N Engl J Med. 2021 May 13;384(19):1836-1847. doi: 10.1056/NEJMra1916801. No abstract available.
- Background: PubMed 23268518Piaggio 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.
- Background: PubMed 26579847Aziz 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.
- Background: PubMed 35373840Hansel 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.
- Background: PubMed 34762729Apfelbaum 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.
- Background: PubMed 21447488Cook 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laringocel® videolaryngoscope and C-MAC® D-Blade videolaryngoscope in people with Airway Management and Intubation, Endotracheal, run by Mario Zamudio at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriel R Muñoz Miranda, MD, MSc (candidate) (+57 3187162895, gabrielr.munozm@udea.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First-attempt orotracheal intubation success (time frame: During the intubation procedure (intraoperative, immediately after induction of anesthesia)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07239141, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.