Two Video Laryngoscopes (Laringocel® and C-MAC®) for First-Attempt Intubation in Adults Undergoing Elective Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMario Zamudio
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Laringocel® videolaryngoscope
DeviceOrotracheal 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
DeviceOrotracheal 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.
Treatment groups
252 Participants
are divided into 2 treatment groupsGroup A: LaringocelExperimental treatment 1 intervention
Group B: C-MAC D-BladeActive comparator 1 intervention
Trial outcomes
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.
Time frame
During the intubation procedure (intraoperative, immediately after induction of anesthesia)Secondary outcomes
1
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.
Time frame
During the intubation procedure (intraoperative, immediately after induction of anesthesia)2
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.
Time frame
During the intubation procedure (intraoperative, immediately after induction of anesthesia)3
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.
Time frame
During the intubation procedure (intraoperative, immediately after induction of anesthesia).4
Intubation time
Time in seconds from insertion of the videolaryngoscope into the mouth until confirmation of successful tracheal tube placement by capnography.
Time frame
During the intubation procedure (intraoperative, immediately after induction of anesthesia)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Mario Zamudio
Lead sponsor
Universidad de Antioquia
Sponsor institution
Source ClinicalTrials.gov