Novel SaCoVLM™ Video Laryngeal Mask Airway as an Intubation Conduit in Morbidly Obese Bariatric Surgery

Time to Successful SaCoVLM™ Insertion (seconds)

Time to successful insertion is measured in seconds as a continuous time-to-event variable. Successful insertion is defined as proper placement of the SaCoVLM™ with visible chest rise and a square-wave capnography trace. Shorter time indicates a better outcome (faster airway establishment). The primary metric reported will be the median insertion time with interquartile range, along with the proportion of successful insertions within 60, 90, and 120 seconds.

Time frame: From the start of device insertion into the mouth until the time of successful SaCoVLM™ placement with first confirmed ventilation, assessed up to 120 seconds. If insertion is not successful within 120 seconds, the event is censored at 120 seconds.

Number of SaCoVLM™ Insertion Attempts per Participant

An insertion attempt is defined as any entry of the SaCoVLM™ into the patient's mouth with the intention of placement, regardless of depth or success. Each withdrawal of the device from the mouth followed by re-entry counts as a new attempt. The total number of attempts required to achieve successful placement (confirmed by end-tidal CO₂ waveform) is recorded. Fewer attempts indicate a better outcome (easier insertion). The primary metric reported will be the mean (or median) number of attempts, the range, and the proportion of participants requiring 1, 2, or ≥3 attempts.

Time frame: From the first insertion attempt until successful SaCoVLM™ placement is achieved or until the procedure is abandoned, assessed during the initial airway management procedure (up to 120 seconds or a maximum of 3 attempts, whichever comes first).

the SaCoVLM™ glottic exposure grades

Time frame: Immediately after SaCoVLM™ placement

Oropharyngeal Leak Pressure (OLP) (cm H₂O)

OLP is measured by closing the adjustable pressure limiting valve of the anesthesia circuit while maintaining a fixed gas flow of 3 L/min. The airway pressure at which an audible leak occurs around the device (or the pressure at which the capnography waveform flattens) is recorded as the OLP in cm H₂O. Higher OLP indicates a better seal and is considered a better outcome (more effective supraglottic airway seal). The primary metric reported will be the mean (or median) OLP with standard deviation or interquartile range.

Time frame: Immediately after successful SaCoVLM™ insertion and before start of positive pressure ventilation (measured at a single time point: within 1 minute of confirmation of correct placement)

Proportion of Participants Requiring Any Airway Optimization Maneuver During SaCoVLM™ Placement

The airway optimization protocol includes predefined maneuvers to improve ventilation or seal when SaCoVLM™ placement is suboptimal (e.g., audible leak \>30 cm H₂O, absent capnography, or inability to ventilate). Recorded maneuvers may include: chin lift, jaw thrust, head extension/flexion, device rotation, partial withdrawal and reinsertion, or changing to a different size/type of supraglottic airway. The primary outcome metric is the proportion of participants requiring any optimization maneuver during the specified time frame. Secondary metrics include the number of different maneuvers used per participant and the specific maneuvers most frequently applied. No numerical scale is used; this is a descriptive/binary outcome (optimization required: yes/no). Fewer required maneuvers indicate a better outcome (easier device placement).

Time frame: During the initial airway management procedure, from the start of the first insertion attempt until successful ventilation is confirmed (assessed up to 120 seconds or a maximum of 3 attempts).

Incidence and Severity of Postoperative Sore Throat (POST) as Assessed by a 4-Point Scale

POST is measured using a 4-point categorical scale: 0 = no sore throat 1. = mild sore throat (complains only when asked) 2. = moderate sore throat (complains spontaneously) 3. = severe sore throat (hoarseness or difficulty swallowing) Minimum value = 0, maximum value = 3. Higher scores indicate a worse outcome (more severe sore throat). The primary metrics reported will be: Incidence = proportion of participants with any POST (score ≥1) at the specified time point Severity = mean (or median) score at each time point, plus the proportion with severe POST (score 3)

Time frame: At 72 hours after the end of surgery

Incidence and Severity of Postoperative Hoarseness as Assessed by a 4-Point Scale

Postoperative hoarseness is measured using a 4-point categorical scale: 0 = no hoarseness (voice normal) 1. = mild hoarseness (voice slightly different but able to speak without difficulty) 2. = moderate hoarseness (voice obviously changed, speaking with effort) 3. = severe hoarseness (voice barely audible or aphonic)

Time frame: At 24 hours after the end of surgery

Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

Adverse events (AEs) are defined according to \[specify system, e.g., Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 or a standardized surgical complication list\]. AEs include, but are not limited to: hypoxia, bradycardia, hypotension, laryngospasm, bronchospasm, dental trauma, bleeding, and allergic reaction. Each AE is graded for severity (mild/moderate/severe) and relationship to the procedure. The primary metric reported will be the proportion of participants experiencing at least one AE during the specified time frame. Secondary metrics include the total number of AEs, type and frequency of specific AEs, and proportion of severe AEs. No scale is used for the primary binary outcome; severity grading follows CTCAE (Grade 1-5, where higher grade = worse outcome).

Time frame: From the end of surgery until 72 hours postoperatively