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临床试验/NCT02834039
NCT02834039已完成不适用

Comparison of Ventilation Distribution Between Tidal Volume 6ml/kgBW and 10ml/kgBW in Laparoscopic Nephrectomy Patients

Indonesia University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Tidal impedance variation regional (TIV-ROI)

研究概览

简要总结

This study aims to compare the ventilation Distribution between tidal Volume 6ml/kgBW and tidal volume 10ml/kgBW in laparoscopic nephrectomy patients

详细描述

Approval from Ethical Committee of Faculty of Medicine University of Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Non-invasive blood pressure (NIBP) monitor, electrocardiogram (ECG) and pulse-oximeter was set on the subjects in the operation room. Anesthesia procedure was epidural regional block. After given premedication (midazolam 0.05 mg/kgBW and fentanyl 1-2 ug/kgBW), induced with propofol, 1-2 mg/kgbb, endotracheal tube intubation was done facilitated by atracurium 0.5 mg/kgbb. Mechanical ventilation was set up with volume control mode, (Positive End Expiratory Pressure) PEEP 5cmH2O (5 centimeters of water), O2 fraction (FiO2) 30-50%, target carbondioxide (CO2) 35-45%. Volume tidal was given according to the group (6 mL/kgBW or 10 ml/kgBW). Hemodynamic, ventilation parameter, Electrical Impedance Tomography (EIT) parameter were recorded. If desaturation happened intraoperatively will be managed by increasing FiO2 and recruitment maneuver until oxygen saturation (SpO2) >95%. Data was analyzed using Statistical Program for Social Sciences (SPSS), for numeric data using unpaired T-test or Mann-Whitney-U test, for categorical data using Chi-square or Fisher Exact Test. Significant value is p<0.05.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects aged 18-60 years old
  • Subjects with good health condition (did not suffer from cancer, diabetes mellitus, kidney diseases, cardiovascular diseases, liver diseases, hematologic disorders, HIV, hepatitis)
  • Subjects had the same blood type with the renal recipients and had passed cross match test
  • Subjects were willing to be renal donors.

排除标准

  • Subjects with pulmonary diseases or PaO2 (arterial partial pressure of oxygen) /FiO2 < 300 mmHg
  • Subjects with Body Mass Index (BMI) > 30 kg/m2
  • Subjects who had mechanical ventilation 2 weeks prior to the surgery
  • Subjects with congestive heart failure
  • Subjects with neuromuscular diseases.
  • Drop out criteria:
  • Subjects with intraoperative pulmonary complications not due to ventilation
  • Subjects with intraoperative cardiac arrest
  • Subjects with desaturation that could not be managed by FiO2 increase, PEEP or recruitment maneuver, and required tidal volume changes.

研究组 & 干预措施

Tidal volume 6 ml/kgBW

Active Comparator

Tidal volume 6 ml/kgBW was given to patients after endotracheal tube was inserted properly

干预措施: Tidal volume 6 ml/kgBW (Procedure)

Tidal volume 10 ml/kgBW

Active Comparator

Tidal volume 10 ml/kgBW was given to patients after endotracheal tube was inserted properly.

干预措施: Tidal volume 10 ml/kgBW (Procedure)

结局指标

主要结局

Tidal impedance variation regional (TIV-ROI)

时间窗: 2 months

Evaluating ROI values displayed on EIT Dräger PulmoVista® 500 monitor.

Global End expiratory lung impedance difference (ΔEELI-g)

时间窗: 2 months

Global End expiratory lung impedance difference (ΔEELI-g) will be measured by the EIT monitor.

Regional End expiratory lung impedance difference (ΔEELI- ROI)

时间窗: 2 months

Regional End expiratory lung impedance difference (ΔEELI-g) will be measured by the EIT monitor.

Compliance regional (CR)

时间窗: 2 months

Tidal Impedance Variation value divided by atmospheric pressure above PEEP value.

次要结局

未报告次要终点

研究者

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

Dita Aditianingsih

Consultant, Anesthesiologist

Indonesia University

研究点 (2)

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