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临床试验/NCT04247477
NCT04247477已完成不适用

Comparison of Different Positive End-expiratory Pressure Titration Strategies Using ELectrical Impedance Tomography in Patients With Acute Respiratory Distress Syndrome : the DELTA Physiological Study

University Hospital, Angers2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2020年9月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
2
主要终点
Change in PaO2 (mmHg)

研究概览

简要总结

The aim of the this study is to assess the short term physiological effects of 3 ventilation strategies for adult patients with ARDS admitted to intensive care unit.

Two of those strategies are based on electrical impedance tomography (EIT) monitoring.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • patients with moderate to severe ARDS, defined by the Berlin consensus, at 12 to 48h from diagnosis
  • PaO2/FiO2 ratio < 150 mmHg
  • Patient affiliated to or beneficiary of a health care plan
  • Consent obtained from patient's SDM

排除标准

  • Pneumothorax
  • Contraindication to the insertion of a nasogastric tube with an esophageal balloon
  • Contraindication to the use of Electrical impedance tomography
  • Pregnancy, lactating or parturient woman

结局指标

主要结局

Change in PaO2 (mmHg)

时间窗: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes

As it is a physiological study, all the outcomes will be analyzed with the same importance!

次要结局

  • Expiratory and inspiratory transpulmonary pressure (cmH2O)(Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes)
  • Regional ventilation distribution (%)(Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes)
  • Change in PaCO2 (mmHg)(Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes)
  • Plateau pressure (cmH2O)(Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes)
  • Positive end expiratory pressure (cmH2O)(Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes)
  • Overdistension and collapsus (%)(Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes)
  • Center of ventilation (%)(Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes)
  • End expiratory lung volume (mL)(Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes)
  • Blood pressure (mmHg)(Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes)
  • Heart rate (bpm)(Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes)
  • Cardiac output (L/min)(Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes)
  • Global and regional end expiratory lung impedance changes (IU)(Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes)

研究者

发起方
University Hospital, Angers
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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