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

NCT07573813 | Completed DMC

• 2 other identifiers: YXLL-KY-2022 035320.6750.2024-15-19
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Morbidly Obese

Keywords

Video laryngeal mask airway; Morbidly obese patients; Airway management; Laparoscopic sleeve gastrectomy; First-attempt success rate

Outcome Measures

Primary Outcomes (1)

• the first-time success rate of intubation after insertion of SaCoVLM™

  Within 10 minutes following SaCoVLM™ placement

Secondary Outcomes (8)

• Time to Successful SaCoVLM™ Insertion (seconds)

  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

  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

  Immediately after SaCoVLM™ placement

• Oropharyngeal Leak Pressure (OLP) (cm H₂O)

  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

  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).

Study Arms (1)

morbidly obese bariatric surgery

This study was a single-arm prospective study, so there was no grouping.

Device: SaCoVLM™ in Difficult Airways

Interventions

SaCoVLM™ in Difficult Airways DEVICE

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.

morbidly obese bariatric surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population comprised adult patients aged over 18 years (with no upper age limit) diagnosed with morbid obesity.

You may qualify if:

• Adult patients aged over 18 years (no upper age limit)
• Diagnosed with morbid obesity, clinically defined as either:
• Body mass index (BMI) ≥ 40 kg/m², or BMI ≥ 35 kg/m² accompanied by at least one significant obesity-related comorbidity

You may not qualify if:

• Have no clinical indicators of anticipated difficult airway (Mallampati classification IV, thyromental distance \< 6 cm, mouth opening \< 3 cm, severe limited neck extension, or a history of difficult airway management)
• Demonstrate tolerance for laparoscopic surgery and anesthesia
• Be scheduled exclusively for LSG without concurrent additional procedures

Sponsors & Collaborators

• Yongtao Sun: lead

Study Sites (1)

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

Jinan, Shandong, 250014, China

Location

Related Publications (4)

• Harjai M, Alam S, Rastogi S, Kumar S. Effectiveness and Validity of Preoperative Ultrasonographic Airway Assessment and Clinical Screening Tests to Predict Difficult Laryngoscopy: A Prospective, Observational Study. Cureus. 2023 Jul 15;15(7):e41933. doi: 10.7759/cureus.41933. eCollection 2023 Jul.

  PMID: 37583718 BACKGROUND

• Arterburn DE, Telem DA, Kushner RF, Courcoulas AP. Benefits and Risks of Bariatric Surgery in Adults: A Review. JAMA. 2020 Sep 1;324(9):879-887. doi: 10.1001/jama.2020.12567.

  PMID: 32870301 BACKGROUND

• Davies MJ, D'Alessio DA, Fradkin J, Kernan WN, Mathieu C, Mingrone G, Rossing P, Tsapas A, Wexler DJ, Buse JB. Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2018 Dec;41(12):2669-2701. doi: 10.2337/dci18-0033. Epub 2018 Oct 4.

  PMID: 30291106 BACKGROUND

• Wang Y, Zhao L, Gao L, Pan A, Xue H. Health policy and public health implications of obesity in China. Lancet Diabetes Endocrinol. 2021 Jul;9(7):446-461. doi: 10.1016/S2213-8587(21)00118-2. Epub 2021 Jun 4.

  PMID: 34097869 RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yongtao Sun

  Shandong First Medical University

  PRINCIPAL INVESTIGATOR

• Min Zhang

  Shandong First Medical University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: May 7, 2026
• Study Start: May 1, 2022
• Primary Completion: May 20, 2023
• Study Completion: May 30, 2023
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From May 2022 to May 2023, we included a total of 57 patients who were scheduled to undergo bariatric surgery.
• Access Criteria: Who Qualified researchers from academic, non-profit, or commercial institutions with an approved research proposal; regulatory authorities; and direct collaborators. What Anonymized IPD, data dictionary, protocol, SAP, and ICF summary. No direct or indirect participant identifiers. How Submit proposal via online portal. Independent review committee approval. Sign data use agreement (non-identification, non-commercial, no third-party sharing). Access via secure virtual research environment or encrypted download; time-limited (e.g., 12 months); audit logs kept.

Locations

CN (1)