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临床试验/NCT02071524
NCT02071524Unknown不适用

Evaluation of the Effects of Fluid Therapy on Respiratory Mechanics

Università degli Studi di Ferrara1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
effects on oxygenation, respiratory mechanics

研究概览

简要总结

The investigators hypothesize that large doses of fluids used during intraoperative could affect lung parenchyma structure and, consequently, gas exchange and respiratory mechanics. The purpose of this study is to evaluate fluids effects on oxygenation, respiratory mechanics, by using two different solutions: crystalloid or colloid.

详细描述

Inclusion Criteria:

  • patients undergoing elective abdominal, thoracic, vascular surgery
  • minimum age 18 years
  • informed consent

Exclusion Criteria:

  • patients with severe cardiomyopathy or severe heart failure
  • history of coagulation disorders
  • patients with severe cardiovascular or respiratory disorders
  • renal insufficiency

Respiratory mechanic parameters (i.e., inspiratory peak pressure, plateau pressure, total airway resistance, and static compliance) are obtained .Blood samples are drawn simultaneously from the arterial catheters for gas analysis. Data were collected after induction of anesthesia (T0) after 1 h (T1), 2 h (T2), 3 h (T3) and at the end of surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients undergoing elective abdominal, thoracic, vascular surgery
  • minimum age 18 years
  • informed consent

排除标准

  • patients with severe cardiomyopathy or severe heart failure
  • history of coagulation disorders
  • patients with severe cardiovascular or respiratory disorders
  • renal insufficiency
  • severe liver diseases

研究组 & 干预措施

Cristalloid

Active Comparator

group cristalloid (ringer lactate)

干预措施: Cristalloid administration (Drug)

colloids

Active Comparator

colloid: cristalloid in according to cardiac output

干预措施: Group Colloid (Drug)

结局指标

主要结局

effects on oxygenation, respiratory mechanics

时间窗: every 30 minutes till the end of surgery

Lung compliance (l/cmH20), Airaway resistance (cmH2O/L/sec) and PaO2 will be measured

次要结局

  • Incidence of respiratory complications(28 days)

研究者

发起方
Università degli Studi di Ferrara
申办方类型
Other
责任方
Principal Investigator
主要研究者

Savino Spadaro

Researcher

Università degli Studi di Ferrara

研究点 (1)

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