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临床试验/NCT02208570
NCT02208570Unknown不适用

Predictability of the Pulse Pressure Variation During Spontaneous Ventilation on the Incidence of Hypotension During Induction of Anesthesia

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2014年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
172
试验地点
1
主要终点
Changes of heart rate and systolic arterial blood pressure from baseline values immediately before tracheal intubation

研究概览

简要总结

The purpose of this study is to find out the predictability of the pulse pressure variation during spontaneous ventilation on the incidence of hypotension during induction of anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing general anesthesia induction with intravenous anesthesia using propofol and remifentanil
  • Patients requiring invasive arterial blood pressure monitoring for the surgery

排除标准

  • Refusal of consent
  • Patients with heart disease (symptomatic valvular heart disease, intracardiac shunt, pulmonary hypertension with pulmonary systolic arterial pressure exceeding 40mmHg)
  • FEV1 ≤ 50% predicted FEV1
  • Patients with chronic renal failure
  • ASA class IV, V, VI
  • Systolic arterial blood pressure below 90mmHg before induction of anesthesia

研究组 & 干预措施

P(+)V(+)

Experimental

PPV>14% before anesthesia induction, HES 6ml/kg infused

干预措施: PPV>14% (Other)

P(+)V(+)

Experimental

PPV>14% before anesthesia induction, HES 6ml/kg infused

干预措施: Volume loading (Drug)

P(+)V(-)

Experimental

PPV>14% before anesthesia induction, no additional volume infused

干预措施: PPV>14% (Other)

P(-)V(+)

Experimental

PPV<14% before anesthesia induction, HES 6ml/kg infused

干预措施: Volume loading (Drug)

P(-)V(+)

Experimental

PPV<14% before anesthesia induction, HES 6ml/kg infused

干预措施: PPV<14% (Other)

P(-)V(-)

Experimental

PPV<14% before anesthesia induction, no additional volume infused

干预措施: PPV<14% (Other)

结局指标

主要结局

Changes of heart rate and systolic arterial blood pressure from baseline values immediately before tracheal intubation

时间窗: Three minutes after anesthesia agent injection

First, we measure the baseline heart rate and systolic arterial blood pressure and calculate the baseline heart rate and blood pressure. At 3 minutes after anesthesia agent injection we record the heart rate and blood pressure, and perform endotracheal intubation. Then we calculate the percentile change of blood pressure and heart rate from the baseline values.

次要结局

  • Changes of heart rate and systolic arterial blood pressure from baseline values, three minutes after intubation(Three minutes after endotracheal intubation)
  • Changes of heart rate and systolic arterial blood pressure from baseline values, three minutes before intubation(Three minutes before endotracheal intubation)

研究者

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

Jae-Hyon Bahk, MD, PhD

Professor

Seoul National University Hospital

研究点 (1)

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