Flow-controlled Ventilation (FCV) in Moderate Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19 - an Interventional Cross-over Study
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
- 否
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
Tom Schepens, MD
Principal investigator, Member of staff at the department of critical care, Doctor of Philosophy, Medical Doctor
University Hospital, Antwerp
