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临床试验/NCT03684291
NCT03684291Unknown不适用

Effects of Two Different Ventilation Modes Used in Gynecologic Laparoscopic Operations Performed in Steep Trendelenburg Position on Hemodynamic Parameters

Ufuk University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
Measurement of changes in MAP

研究概览

简要总结

Different ventilation modes can be used in laparoscopic surgeries. These surgeries are performed in steep Trendelenburg position with serious hemodynamic disturbances. This study aims to observe the hemodynamic effects of two different ventilation modes in laparoscopic gynecologic surgery performed in steep Trendelenburg position.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women of ASA I and II classification between 18-65 years scheduled for elective gynecologic laparoscopic surgery

排除标准

  • Patient refusal to participate
  • Patients with severe cardiac (congestive heart failure etc) and pulmonary (COPD, pulmonary hypertension) disease (ASA > III)
  • Morbid obesity
  • Negative Allen test

结局指标

主要结局

Measurement of changes in MAP

时间窗: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation

Mean arterial pressure (MAP) (mmHg)

Measurement of changes in heart rate

时间窗: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation

Heart rate (bpm)

Measurement of changes in systemic vascular resistance index

时间窗: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation

Systemic vascular resistance index (dyne x sec/cm2)

Measurement of changes in stroke volume index

时间窗: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation

Stroke volume index (mL/m2)

Measurement of changes in cardiac index

时间窗: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation

Cardiac index L(min x m2)

Measurement of changes in stroke volume variation

时间窗: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation

Stroke volume variation (%)

Measurement of changes in cardiac cycle efficiency

时间窗: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation

Cardiac cycle efficiency (units)

Measurement of changes in aortic dp/dt

时间窗: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation

Aortic dP/dt (mmHg/msec)

次要结局

  • Measurement of changes in peak airway pressure(T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation)
  • Measurement of changes in mean airway pressure(T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation)
  • Measurement of changes in plateau airway pressure(T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation)

研究者

发起方
Ufuk University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hakan Yılmaz

Associate Professor

Ufuk University

研究点 (1)

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