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临床试验/NCT04196738
NCT04196738已完成不适用

Comparison of Volume Assist Control, Dual Mode and Airway Pressure Release Ventilation: A Physiological Study

University Hospital, Angers2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年6月30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
20
试验地点
2
主要终点
change of PaO2 (mmHg)

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
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

  • 18 years or older
  • Invasive mechanical ventilation on tracheal probe
  • Acute respiratory distress syndrome, as defined by Berlin conference consensus, during hospitalization in intensive care,
  • Recovery phase of acute respiratory distress syndrome: spontaneous ventilation representing from 20 to 30% of ventilation in APRV mode.
  • No severe acidosis (pH> 7.30)
  • Patient affiliated to or beneficiary of a health care plan
  • Express consent of the patient or his/her 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 (pacemaker)
  • Pregnancy, lactating or parturient woman

结局指标

主要结局

change of PaO2 (mmHg)

时间窗: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes

Arterial partial pressure of dioxygen Of note: As it is a physiological study, all the primary and secondary outcomes will be analyzed with the same importance.

次要结局

  • -Tidal volume variability(15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes)
  • -Respiratory rate variability(15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes)
  • -Respiratory comfort(15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes)
  • -Pressure time product (PTP)(15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes)
  • MAP(15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes)
  • -Patient-ventilator asynchronies(15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes)
  • -expiratory and inspiratory transpulmonary pressure(15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes)
  • -ventilation distribution in the lungs(15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes)
  • -Work of breathing (WOB)(15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes)
  • -P0.1(15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes)
  • HR(15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes)
  • -other arterial parameters of hematosis(15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes)
  • -PEEPi(15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 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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