跳至主要内容
临床试验/NCT05669443
NCT05669443招募中不适用

Application of Individualized Positive End-expiratory Pressure Using Electrical Impedance Tomography (EIT) in Patients Undergoing Robot Assisted Laparoscopic Prostatectomy : a Randomized Controlled Study

Gangnam Severance Hospital2 个研究点 分布在 2 个国家目标入组 42 人开始时间: 2023年4月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
42
试验地点
2
主要终点
PaO2/FiO2

研究概览

简要总结

Steep trendelenburg posture or pneumoperitoneum for surgery causes ventilation problems during surgery, so finding a way to overcome is a challenging task for anesthesiologists. In this study, for patients undergoing robot assisted laparoscopic prostatectomy under general anesthesia, anesthesia is going to perform by applying conventional positive end-expiratory pressure (PEEP 5cmH2O) or individually determined positive end-expiratory pressure values for each patient using electrical impedance tomography. We plan to compare intraoperative ventilation through arterial blood gas analysis to find out the way to improve intraoperative ventilation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 20 - 70 years of age who are scheduled for robotic assisted laparoscopic prostatectomy at the Department of Urology, Gangnam Severance Hospital,
  • ASA-PS (American Society of Anesthesiology Body Rating) I-IlI,
  • Patients with a BMI of 35 kg/m2 or less

排除标准

  • Patients with lung disease
  • BMI >35kg/m2
  • Patients for whom positive end-tidal pressure cannot be applied (large bullae, severe cardiac disease)
  • patient refusal

结局指标

主要结局

PaO2/FiO2

时间窗: end of surgery (before extubation)

PaO2/FiO2 is the ratio of arterial oxygen partial pressure (PaO2) to oxygen fraction (FiO2), and is a commonly used indicator for evaluating pulmonary ventilation and diagnosing lung damage. Using this index, it is possible to determine whether oxygen obtained through the lungs is well delivered to the blood or not. It can be easily obtained by arterial blood gas analysis without complicated formulas or graphs.

次要结局

  • ROI (region of interests)(15 minutes after intubation, 1 hour after pnemoperitoneum, end of surgery (before extubation))
  • inhomogeneity index(15 minutes after intubation, 1 hour after pnemoperitoneum, end of surgery (before extubation))
  • total amount of fluid administered during surgery(end or surgery)
  • PaO2/FiO2(15 minutes after intubation, 1 hour after pnemoperitoneum)
  • total dose of vasopressor administered during surgery(end of surgery)
  • length of hospitalization after surgery(1 month after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chul Ho Chang

Professor

Gangnam Severance Hospital

研究点 (2)

Loading locations...

相似试验