NCT Number: NCT07239141
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Medellín, Antioquia, 050021, Colombia
Location status: Recruiting
Gabriel R Muñoz Miranda, MD
PRINCIPAL_INVESTIGATOR
Hospital Alma Máter de Antioquia
CONTACT
6049595 ext. Option 1 31004
Mario A Zamudio Burbano, MD, Specialist, MSc
SUB_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: During the intubation procedure (intraoperative, immediately after induction of anesthesia)
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.
Time frame: During the intubation procedure (intraoperative, immediately after induction of anesthesia)
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.
Time frame: During the intubation procedure (intraoperative, immediately after induction of anesthesia).
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.
Time frame: During the intubation procedure (intraoperative, immediately after induction of anesthesia)
Time in seconds from insertion of the videolaryngoscope into the mouth until confirmation of successful tracheal tube placement by capnography.
Time frame: Immediately after the intubation procedure (intraoperative period)
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).
Time frame: Immediately after the intubation procedure (intraoperative period)
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.
Time frame: One hour after extubation (post-anesthesia care unit or intensive care unit)
Proportion of participants presenting sore throat, dental injury, or visible mucosal/oropharyngeal lesions after extubation, assessed by direct examination and participant report.
Contact information is provided by the study sponsor or research team.
Mario Zamudio
Other
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
Acronym: LARINGOCOL
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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