Airway Management, Intubation, Endotracheal
Conditions
Keywords
Videolaryngoscopy
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.
Interventions
DEVICELaringocel® 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.
DEVICEC-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.
Sponsors
Mario Zamudio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
the person who generated the randomization sequence is independent from patient recruitment, intervention, and outcome assessment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First-attempt orotracheal intubation success | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Glottic Opening (POGO) score | 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. |
| Fremantle score | 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. |
| Intubation time | 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. |
| Overall orotracheal intubation success within three attempts | 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. |
| Team situation awareness (SAGAT method) | 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. |
| Adverse events related to intubation | 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. |
| Operator satisfaction | 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). |
Countries
Colombia
Contacts
Primary ContactGabriel R Muñoz Miranda, MD, MSc (candidate)
Outcome results
None listed