Boussignac Valve and Fibroptic Intubation in Morbidly Obese Patients, Can it be a Solution?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- number of desaturation events
研究概览
简要总结
In this study, fiberoptic intubation through Boussignac valve, while ventilation of morbidly obese patients is maintained through the ventilator, will be studied. Researchers suggest that the technique will allow more time for intubation trial rather than conventional techniques of intubation without ventilation. the Primary outcome will be the decrease of desaturation events during intubation. Secondary variables will include; stress response to intubation, the incidence of hypercapnia, hemodynamic response to intubation, successful intubation, the time required to intubation and operator satisfaction.
详细描述
All patients will be subjected to a thorough preoperative evaluation including clinical assessment, ECG, Echocardiography, pulmonary function tests and laboratory investigations (CBC, SGOT, SGPT, Albumin, Serum creatinine) and basal arterial blood gases. All patients will be pre-medicated with intravenous infusion of pantoprazole (40 mg) and metoclopramide (10 mg). After pre-oxygenation with 100% oxygen for 5 minutes, anesthesia will be induced using propofol (1-2 mg/kg) preceded by 60 mgs of lidocaine, and rocronium (0.12 mg/kg). Mask ventilation will be maintained while a Boussignac valve is attached between the Y-circuit and the face mask. After full relaxation is achieved (60 second after TOF response disappears), intubation attempt will commence.
Intubation technique:
Patients of both, patients will be put in HELP position to facilitate both ventilation and incubation
- In C group: mask ventilation will be terminated then FOB intubation will be done by experienced anesthist.
- In B group: Mask ventilation will be continued and FOB intubation will be performed from Boussignac valve opening.
Data collection:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Morbidly obese patients (BMI above 40kg/m2) scheduled for elective surgery, with age between 20 to 45 years
排除标准
- •unstable ischemic heart disease, uncontrolled systemic hypertension, previous history of difficult intubation and patients with basal oxygen saturation less than 94%
研究组 & 干预措施
B group
Mask ventilation will be continued and fiberoptic intubation will be performed from Boussignac valve opening by an experienced anesthetist.
干预措施: Fibroptic intubation through Boussignac valve opening (Device)
C group
mask ventilation will be terminated then fiberoptic intubation will be done by an experienced anesthetist.
干预措施: Classic Fibroptic intubation (Device)
结局指标
主要结局
number of desaturation events
时间窗: 3 minutes after the start of intubation attempt
desaturation (spo2 less than 94) during fibroptic intubation of morbidly obese patients
次要结局
未报告次要终点