跳至主要内容
临床试验/NCT05642832
NCT05642832招募中不适用

Feasibility of Reducing Respiratory Drive in Patients with Acute Hypoxemic Respiratory Failure Using the Through-flow System

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
2
主要终点
Esophageal pressure swing (respiratory effort)

研究概览

简要总结

Mechanical ventilation can lead to diaphragm and lung injury. During mechanical ventilation, the diaphragm could be completely rested or it could be overworked, either of which may cause diaphragm injury. Mechanical stress and strain applied by mechanical ventilation or by the patient's own respiratory muscles can also cause injury to the lungs. Diaphragm and lung injury are associated with increased morbidity and mortality. Throughflow is a novel system that can reduce dead space without the need to increase the tidal ventilation, reducing the ventilatory demands and respiratory drive.

详细描述

Patients with acute respiratory failure often develop significant diaphragm weakness during mechanical ventilation. Diaphragm weakness is associated with prolonged duration of mechanical ventilation and higher risk of death. Clinical data and experimental evidence indicate that the ventilator injures the diaphragm via two opposing mechanisms, disuse and excessive loading. Cessation of diaphragm activity leads to rapid disuse atrophy within hours. On the other hand, high inspiratory loads result in myofibril edema, inflammation and contractile dysfunction. In light of this, studies found that patients with an intermediate level of inspiratory effort, similar to that of healthy subjects breathing at rest, exhibited the shortest duration of ventilation.

Arterial CO2 (PaCO2) tension and physiological dead space play an important role in determining the ventilatory requirements and respiratory drive in patients with AHRF.

Throughflow (Neurovent) is a novel system that reduces anatomical dead space by providing a constant flow of fresh gas (i.e., gas that is free of CO2) during inspiration in patients receiving invasive mechanical ventilation. By clearing the CO2 that normally remains in the upper airway after exhalation (anatomical dead space), TF can dramatically reduce anatomical dead space without the need to increase the delivered VT.

Reducing dead space offers a theoretical benefit in mitigating the mechanisms of lung and diaphragm injury during spontaneous breathing by reducing the ventilation demands to the lungs. Animal studies using the TF have shown extremely promising results, however, the impact of reducing anatomical dead space using the TF on gas exchange, ventilation, and respiratory drive in critically ill patients with AHRF is unknown.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

  • PaO2/FiO2 less than or equal to 300 at time of screening
  • Oral endotracheal intubation with ETT 7.5 or 8.0 and on invasive mechanical ventilation
  • Bilateral airspace opacities on chest radiograph or chest CT scan

排除标准

  • Contraindication to esophageal catheterization (upper gastrointestinal tract surgery within preceding 6 weeks, bleeding esophageal/gastric varices)
  • Intubation for traumatic brain injury or stroke
  • Intracranial hypertension (suspected or diagnosed by medical team)
  • Anticipated liberation from mechanical ventilation within 24 hours

结局指标

主要结局

Esophageal pressure swing (respiratory effort)

时间窗: 24 hours

Changes in esophageal pressure swing from baseline to protocol completion will be described using central tendency and dispersion measurements (median and 25%-75% interquartile range) for each variable at each time point of the protocol

Dynamic driving transpulmonary pressure (lung-distending pressure)

时间窗: 24 hours

Changes in the dynamic driving transpulmonary pressure from baseline to protocol completion will be described using central tendency and dispersion measurements (median and 25%-75% interquartile range) for each variable at each time point of the protocol

Oxygenation (PaO2/FiO2 ratio)

时间窗: 24 hours

Changes in PaO2/FiO2 from baseline to protocol completion will be described using central tendency and dispersion measurements (median and 25%-75% interquartile range) for each variable at each time point of the protocol

次要结局

  • Rate of serious adverse events(24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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