The Effect of Prolonged Inspiratory Time on Gas Exchange During Robot-assisted Laparoscopic Surgery With Steep Trendelenburg Position : A Crossover Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- PaCO2 (mmHg) in the patient's arterial blood gas analysis
研究概览
简要总结
Gas exchange disturbance frequently occurs in steep Trendelenburg position during robot-assisted laparoscopic prostatectomy or cystectomy. Due to increased intrathoracic pressure and absorbed carbon dioxide (CO2) gas insufflated into abdominal cavity, hypercapnia as well as hypoxia may occur. Inverse ratio ventilation or prolonged inspiratory time during mechanical ventilation has been reported to be improve gas exchange in adult respiratory distress syndrome. The investigators attempt to test the hypothesis that prolonged inspiratory time may improve the gas exchange during robot-assisted laparoscopic urologic surgery.
详细描述
Gas exchange disturbance frequently occurs in steep Trendelenburg position during robot-assisted laparoscopic prostatectomy or cystectomy. Due to increased intrathoracic pressure and absorbed CO2 gas insufflated into abdominal cavity, hypercapnia as well as hypoxia may occur. Inverse ratio ventilation or prolonged inspiratory time during mechanical ventilation has been reported to be improve gas exchange in adult respiratory distress syndrome. The investigators attempt to test the hypothesis that prolonged inspiratory time (I:E ratio = 1:1) may improve the gas exchange during robot-assisted laparoscopic urologic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists physical status class I-II and scheduled for an elective robot-assisted laparoscopic radical prostatectomy or robot-assisted laparoscopic radical cystectomy
- •Patients who voluntarily decides to participate in the trial and has agreed in written informed consent
排除标准
- •Patients with the anatomical abnormalities of respiratory system(abnormal airway anatomy, severe scoliosis, post-pneumonectomy state), severe chronic respiratory diseases, chronic obstructive pulmonary disease (COPD), asthma, heart failure, obesity ( Body Mass Index [BMI] > 30kg/m2), severe hepatic failure or renal failure
研究组 & 干预措施
1:2, 1:1 group
Inspiratory to expiratory time ratio (I:E ratio) of 1:2 during the first one hour of laparoscopy and then switched to I:E ratio of 1:1 during the rest time of laparoscopy.
干预措施: Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:2 to 1:1) (Device)
1:1, 1:2 group
Inspiratory to expiratory time ratio (I:E ratio) of 1:1 during the first one hour of laparoscopy and then switched to I:E ratio of 1:2 during the rest time of laparoscopy.
干预措施: Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:1 to 1:2) (Device)
结局指标
主要结局
PaCO2 (mmHg) in the patient's arterial blood gas analysis
时间窗: 60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
PaCO2 (arterial partial pressure of carbon dioxide)
次要结局
- Alveolar-arterial oxygen difference(120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning)
- PaO2 (mmHg) in the patient's arterial blood gas analysis(10 min after restoration of supine position)
- oxygen index(120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning)
- PaCO2 (mmHg) in the patient's arterial blood gas analysis(10 min after restoration of supine position)
- Respiratory compliance (Static, Dynamic)(120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning)
研究者
Won Ho Kim, MD
Clinical Associate Professor
Seoul National University Hospital