Comparison of Three Modes of Ventilation During Robot-assisted Hysterectomy in Trendelenburg Position: Volume Controlled Ventilation, Pressure Controlled Ventilation, and Pressure Controlled Ventilation With Volume Guarantee.
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Peak airway pressure
研究概览
简要总结
Robot-assisted hysterectomy is associated with pneumoperioneum with CO2 and Trendelenburg position, which may have adverse cardiopulmonary effects. A new ventilation mode; pressure-controlled ventilation with volume guaranteed mode (PCV-VG) delivers constant tidal volume with constant inspiratory pressure, using a decelerating flow pattern. This prospective, randomized study is designed to compare the effects of PCV-VG, volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV) on respiratory and hemodynamic variables in patients undergoing Robot-assisted hysterectomy.
详细描述
- Total 60 patients with American Society of Anesthesiologists physical status I-II who underwent Robot-assisted hysterectomy were enrolled.
- All patients were fasted for 8 hours before the surgery and were premedicated with intramuscular glycopyrrolate 0.2 mg. Anesthesia was induced with intravenous remifentanil (0.1-0.2 ug/kg/min), propofol (1.5-2 mg/kg) and rocuronium (0.6 mg/kg) and maintained with sevoflurane (2.0-2.5 vol%) in inspired oxygen fraction with 0.5, remifentanil (0.05-0.3 ug/kg/min) and vecuronium (0.03-0.05 mg/kg/hr).
- A 20 G catheter was inserted into the radial artery to monitor continuous arterial pressure and hemodynamic variables (cardiac output, cardiac index, stroke volume, stroke volume index, and stroke volume variation) monitoring.
- All patients were ventilated with a Datex-Ohmeda Ventilator (S/5 AVANCE). Patients were randomized to receive VCV (n=20), PCV (n=20), or PCV-VG (n=20) mode. The tidal volume was set to deliver 8 mL/kg of ideal body weight. The respiratory rate(RR) was adjust to maintain end tidal CO2 (ETCO2) 32-37 mmHg.
- Hemodynamic variables (mean blood pressure, heart rate, cardiac output, cardiac index, stroke volume, stroke volume index, and stroke volume variation) , respiratory variables (saturation, RR, ETCO2, peak airway pressure, mean airway pressure and lung dynamic compliance) and arterial gas analyses were recorded at 4 stages: (1) 15 minutes after induction in supine position, (2) 30 minutes after pneumoperitoneum and Trendelenburg position, (3) 60 minutes after pneumoperitoneum and Trendelenburg position, (4) 15 minutes after pneumoperitoneum withdrawal in supine position.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who were scheduled for Robot-assisted hysterectomy
- •American Society of Anesthesiologists physical status I-II
排除标准
- •Age under 20 years old or over 65 years old
- •Body mass index > 30 kg/m2
- •Systolic blood pressure < 100 mmHg
- •Heart rate < 60 bpm
- •Uncompensated cardiac disease
- •FEV1 < 60%
- •Hypoxemia (PaO2 < 60 mmHg or oxygen saturation < 90%)
研究组 & 干预措施
VCV
Volume controlled ventilation
干预措施: Group VCV (Device)
PCV
Pressure controlled ventilation
干预措施: Group PCV (Device)
PCV-VG
Pressure controlled ventilation with volume guarantee
干预措施: Group PCV-VG (Device)
结局指标
主要结局
Peak airway pressure
时间窗: 2-3 hours through the surgery
The highest level of pressure applied to the lung during inhalation
次要结局
未报告次要终点
研究者
Eun Young Park
Associate professor
Hallym University Medical Center