跳至主要内容
临床试验/NCT04894214
NCT04894214已完成不适用

Flow-controlled Ventilation (FCV) in Moderate Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19 - an Interventional Cross-over Study

University Hospital, Antwerp1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2021年1月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
1
主要终点
Arterial oxygen tension, PaO2 (mmHg)

研究概览

简要总结

Flow controlled ventilation (FCV) is a fairly new mode of mechanical ventilation, consisting of a constant inspiratory and expiratory flow. Inspiration is thus comparable to volume controlled ventilation (VCV). The actively controlled, constant flow during expiration is unique. FCV is known to minimize dissipated energy to the lung [ref] and is therefore supposed to aid in lung protective ventilation.

The VICAR study is designed as a prospective single cohort crossover trial. The intervention consists of a sequence of respiratory modes: baseline pressure controlled ventilation (PCV) during 5 minutes, followed by 30 minutes of FCV with an evone respirator (Ventinova Medical B.V., Eindhoven, The Netherlands) and eventually 30 minutes of VCV. Every participant will receive the intervention. Respiratory rate (RR), positive end-expiratory pressure (PEEP) and inspiratory fraction of oxygen (FiO2) will be held constant. According to the manufacturers guidelines, an I:E ratio of 1:1 will be pursued during FCV. During FCV, the respirator will be set with the same PIP as during baseline PCV. For VCV, the same tidal volume as during baseline PCV will be set.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

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

入选标准

  • P/F-ratio: 100-200 (moderate ARDS)
  • SpO2 88-94%
  • PaO2 60-80 mmHg
  • COVID-19 positive on a PCR test

排除标准

  • BMI > 40 kg/m²
  • Prone ventilation
  • Already invasively mechanically ventilated for more than 10 days
  • Refusal to participate

结局指标

主要结局

Arterial oxygen tension, PaO2 (mmHg)

时间窗: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)

Arterial partial oxygen tension as measured on an arterial blood gas sample.

P/F ratio or Horowitz index (mmHg)

时间窗: Post hoc calculation

Ratio of the arterial oxygen tension PaO2 (mmHg) divided by the inspiratory fraction of oxygen FiO2.

次要结局

  • SpO2 (%)(Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV))
  • RR(Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV))
  • Pmean(Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV))
  • PEEP (cmH2O)(Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV))
  • FiO2(Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV))
  • MV(Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV))
  • PaCO2(Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV))
  • Pplat(Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV))
  • PIP(Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV))
  • ABPsys(Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV))
  • TV(Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV))
  • ABPdia(Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV))
  • ABPmean(Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV))
  • HR(Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV))

研究者

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

Tom Schepens, MD

Principal investigator, Member of staff at the department of critical care, Doctor of Philosophy, Medical Doctor

University Hospital, Antwerp

研究点 (1)

Loading locations...

相似试验