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NCT07573813

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

Sponsor: Yongtao Sun

View on ClinicalTrials.gov

Summary

Background: The SaCoVLM™ video laryngeal mask is a novel video-assisted device that integrates the functions of both a dual-channel laryngeal mask airway (LMA) and an intubating laryngeal mask airway (ILMA). At present, there are relatively few studies on awake airway management for obese patients who undergo laparoscopic sleeve gastrectomy (LSG). To evaluate the efficacy and safety of the SaCoVLM™ video laryngeal mask airway as an intubation conduit in morbidly obese patients undergoing laparoscopic sleeve gastrectomy. Patients and methods: This single-arm prospective study evaluated the efficacy and safety of the SaCoVLM™ video laryngeal mask airway in 57 morbidly obese patients (BMI ≥35 kg/m²) undergoing LSG.

Official title: Novel SaCoVLM™ Video Laryngeal Mask Airway as an Intubation Conduit in Morbidly Obese Bariatric Surgery: a Single-arm Prospective Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

57

Start Date

2022-05-01

Completion Date

2023-05-30

Last Updated

2026-05-07

Healthy Volunteers

No

Interventions

DEVICE

SaCoVLM™ in Difficult Airways

As part of the awake airway management protocol initiated in the operating room, patients were first instructed to hold 10 mL of dyclonine mucilage orally for approximately 10 minutes to achieve topical oropharyngeal anesthesia. This was followed by intravenous administration of midazolam 2 mg and atropine 0.4 mg, and bilateral ultrasound-guided superior laryngeal nerve block using 0.375% ropivacaine. A properly sized laryngeal mask was selected. The posterior surface of the cuff was lubricated with a water-based surgical lubricant. Under awake conditions, patients were instructed to open their mouths to facilitate SaCoVLM™ insertion. Optimal positioning was confirmed by visualization of complete glottic structures on the monitor screen. The glottic exposure grade was as we previously described . The cuff was inflated using a handheld manometer, and the mask was connected to the anesthesia machine. Clear glottic visualization on the monitor and the presence of a regular EtCO₂ waveform.

DEVICE

SaCoVLM™ in Difficult Airways

As part of the awake airway management protocol initiated in the operating room, patients were first instructed to hold 10 mL of dyclonine mucilage orally for approximately 10 minutes to achieve topical oropharyngeal anesthesia. This was followed by intravenous administration of midazolam 2 mg and atropine 0.4 mg, and bilateral ultrasound-guided superior laryngeal nerve block using 0.375% ropivacaine. A properly sized laryngeal mask was selected. The posterior surface of the cuff was lubricated with a water-based surgical lubricant. Under awake conditions, patients were instructed to open their mouths to facilitate SaCoVLM™ insertion. Optimal positioning was confirmed by visualization of complete glottic structures on the monitor screen. The glottic exposure grade was as we previously described. The cuff was inflated using a handheld manometer, and the mask was connected to the anesthesia machine. Clear glottic visualization on the monitor and the presence of a regular EtCO₂ waveform.

Locations (1)

The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, China