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临床试验/NCT07573813
NCT07573813已完成不适用

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

Yongtao Sun1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
57
试验地点
1

研究概览

简要总结

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.

详细描述

All anesthesiologists in this study underwent centralized training prior to trial initiation, with documented certification in protocol-specific procedures. No preoperative medications were administered to any patients. Upon entering the operating room, patients were positioned in a semi-fowler position, with intravenous access established. Standard monitoring protocols were implemented, including electrocardiography (ECG), heart rate (HR), non-invasive blood pressure (NIBP), pulse oximetry (SpO₂), end-tidal carbon dioxide (EtCO₂), and bispectral index (BIS), alongside radial artery catheterization for invasive blood pressure monitoring. All patients underwent awake insertion of the SaCoVLM™, with surgery completed under general anesthesia combining the video laryngeal mask and endotracheal intubation.

Immediately upon arrival in the operating room, patients were instructed to hold 10 mL of dyclonine mucilage orally for approximately 10 minutes to achieve topical anesthesia. Premedication included midazolam 2 mg and atropine 0.4 mg, followed by bilateral ultrasound-guided superior laryngeal nerve block using 0.375% ropivacaine. A properly sized laryngeal mask was selected, and under awake conditions, patients were instructed to open their mouths to facilitate SaCoVLM™. 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 confirmed proper mask alignment, after which rapid anesthesia induction was initiated.

If suboptimal positioning occurred, the up-down maneuver, cricoid pressure, cuff pressure adjustment, fiberoptic bronchoscopy-guided intubation were applied for minor adjustments. Under direct video guidance, the endotracheal tube was gently advanced along the natural curvature of the airway. Successful intubation was defined by unimpeded tube passage, direct visualization of tracheal entry, and sustained EtCO₂ waveform. Following intubation, the breathing circuit was immediately connected, and bilateral lung auscultation confirmed symmetrical breath sounds before securing both the mask and endotracheal tube. Intraoperative fluid administration and vasoactive medications were adjusted based on vital signs, urine output, and physiological requirements.

Postoperatively, the endotracheal tube was removed under deep anesthesia, and the video laryngeal mask was retained for transfer to the post-anesthesia care unit (PACU). The laryngeal mask was removed only after patients regained adequate spontaneous respiration, demonstrated responsiveness to verbal commands, and met established extubation criteria.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究者

发起方
Yongtao Sun
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yongtao Sun

Deputy Director

Qianfoshan Hospital

研究点 (1)

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