Ultrasound-Guided Optimization of Inspiratory Pressure During Facemask Ventilation in Morbidly Obese Patients to Prevent Gastric Insufflation: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Incidence of Gastric insufflation (ultrasound-confirmed) during FMV
研究概览
简要总结
The goal of this randomized clinical trial is to optimize the inspiratory pressure during facemask ventilation (FMV) in morbidly obese patients (BMI ≥40 kg/m²), to ensure adequate ventilation while minimizing the risk of gastric insufflation by real-time ultrasound guidance
详细描述
Morbid obesity, defined as a body mass index (BMI) ≥ 40 kg/m², presents significant challenges during the management of the airway and ventilation under general anesthesia. One of the critical issues is the increased risk of gastric insufflation during facemask ventilation (FMV), which can lead to pulmonary aspiration, reduced lung compliance, and impaired oxygenation. Therefore, optimizing inspiratory pressure to ensure adequate ventilation while minimizing the risk of gastric insufflation is paramount in this population.
Ultrasound imaging has emerged as a valuable, non-invasive tool for real-time assessment of gastric content and volume. Recent studies have demonstrated the utility of gastric ultrasonography in detecting gastric insufflation during positive pressure ventilation. By visualizing the antrum and measuring the cross-sectional area , anesthesiologists can identify even small volumes of air entering the stomach, which might not be clinically apparent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (18-65 years old) scheduled for elective surgery under general anesthesia requiring facemask ventilation.
- •Morbid obesity (BMI ≥40 kg/m²).
- •American Society of Anesthesiologists (ASA) physical status II-III.
- •Normal upper gastrointestinal anatomy (no history of gastric surgery, esophageal strictures, or hiatus hernia).
- •Fasted for at least 6 hours for solids and 2 hours for fluids (standard preoperative fasting guidelines).
排除标准
- •• Emergency surgery (due to inability to ensure proper fasting or preoperative assessment).
- •Known or suspected difficult airway (Mallampati class IV, limited neck mobility, or history of difficult intubation).
- •Gastroesophageal reflux disease (GERD) or high aspiration risk (e.g., pregnancy, symptomatic hiatal hernia).
- •Contraindications to facemask ventilation (facial trauma, beard/mask seal interference).
- •Severe cardiopulmonary disease (e.g., severe COPD, pulmonary hypertension, or unstable angina).
- •Neuromuscular disorders affecting respiratory function.
- •Refusal to participate or inability to provide informed consent.
研究组 & 干预措施
group A
This arm will be subjected to inspiratory pressure 10 cmH₂O
干预措施: "Ultrasound-Guided Optimization of Inspiratory Pressure During Facemask Ventilation" (Device)
group B
This arm will be subjected to inspiratory pressure 15 cmH₂O
干预措施: "Ultrasound-Guided Optimization of Inspiratory Pressure During Facemask Ventilation" (Device)
group C
This arm will be subjected to inspiratory pressure 20 cmH₂O
干预措施: "Ultrasound-Guided Optimization of Inspiratory Pressure During Facemask Ventilation" (Device)
group D
This arm will be subjected to inspiratory pressure 25 cmH₂O
干预措施: "Ultrasound-Guided Optimization of Inspiratory Pressure During Facemask Ventilation" (Device)
结局指标
主要结局
Incidence of Gastric insufflation (ultrasound-confirmed) during FMV
时间窗: At 30 seconds, 60 seconds, and 90 seconds after induction
次要结局
- End tidal CO2(At baseline and 30 seconds, 60 seconds, and 90 seconds during FMV)
- Antral cross-sectional area(at baseline (15 minutes before induction) and 30, 60, 90 seconds during FMV.)
- Heart rate(At baseline, 30, 60, 90 seconds during facemask ventilation and one minute after endotracheal tube placement)
- Mean arterial blood pressure(At baseline, 30, 60, 90 seconds during facemask ventilation and one minute after endotracheal tube placement)
- Hypoxia occurrence(Monitored continuously from induction of anesthesia till one minute after endotracheal intubation)
- Tidal volume (mL/kg ideal body weight) and peak inspiratory pressure(at 30, 60, and 90 seconds of facemask ventilation (FMV))
- Oxygen saturation (SpO₂)(At baseline and 30 seconds, 60 seconds, and 90 seconds during FMV)
- Aspiration events(Continuously monitored, intraoperatively and postoperatively (24-hour follow-up).)
研究者
Mohamed abd-elrazik mustafa mansour mohamed
assistant lecturer
Benha University