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临床试验/NCT05406427
NCT05406427Unknown不适用

Monitorings the Physiological Mechanism of Airway Pressure Release Ventilation(APRV) in Acute Respiratory Distress Syndrome (ARDS) Patients by Electrical Impedance Tomography(EIT)

Wuhan Union Hospital, China1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年3月1日最近更新:
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适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
tidal volume distribution during APRV at 24 hours after APRV
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Effects of airway pressure release ventilation on pulmonary ventilation, shunt and perfusion in patients with ARDS

详细描述

Effects of airway pressure release ventilation on respiratory mechanisms including ventilation distribution, intrapulmonary shunt and V/Q match in lungs of ARDS evaluated by EIT at different time points.

研究设计

研究类型
Observational
观察模型
Other
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

  • •18 years old < age < 80 years old
  • •Diagnosed as moderate or severe ARDS according to the Berlin 2014 definition
  • •Predicted APRV mechanical ventilation for more than 72 hours

排除标准

  • •Excluded if any of the following exclusion criteria are met:
  • •APRV contraindications such as pneumothorax, severe chronic obstructive pulmonary disease, severe asthma, intracranial hypertension
  • •Pregnant women
  • •Severe cardiac dysfunction (New York Heart Association class III or IV, acute coronary syndrome or sustained ventricular tachyarrhythmia), right heart enlargement due to chronic cardiopulmonary disease, cardiogenic shock or cardiac hand
  • •Refractory shock

结局指标

主要结局

tidal volume distribution during APRV at 24 hours after APRV

时间窗: 24 hours after APRV mechanical ventilation

we will use electrical impedance tomography(EIT) to monitor tidal volume distribution during APRV

次要结局

  • tidal volume distribution during APRV(Before APRV mechanical ventilation and 2, 6, 12, 48, 72 hours after APRV mechanical ventilation)
  • Right ventricular area fractional change(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Tricuspid annular systolic S' velocity (TS')(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • V/Q match(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Positive end breath pressure(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Tricuspid annular systolic displacement (TAPSE)(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA)(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Mean arterial pressure (MAP)(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Intrapulmonary shunt during APRV(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Driving pressure(DP)(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • stroke volume index(SVI)(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Mortality at 28 days after randomization(28 days after the beginning of randomization)
  • Plateau pressure(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Compliances(Cs)(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Peak pressure(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Pulmonary circulatory resistance (PVR)(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • cardiac index (CI)(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Heart rate(HR)(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Mean pressure(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • tidal volume(Vt)(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Systolic blood pressure(SBP)(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Cardiac output(CO)(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Stroke volume(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • oxygenation index(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • ICU length of stay(the whole period of stay in ICU from the day of randomization to the day of discharge from ICU or the day of death,assessed up to 90 days)
  • Arterial partial pressure of carbon dioxide(PaCO2)(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Sequential Organ Failure Assessment score(2 hours within admission to ICU and 24 hours after inclusion in the study)
  • Arterial partial pressure of oxygen (PaO2)(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Acute Physiology and Chronic Health Evaluation score(2 hours within admission to ICU and 24 hours after inclusion in the study)
  • Duration of ventilation after randomization(from the day of randomization to the day of extubation or the day of death,assessed up to 90 days)

研究者

发起方
Wuhan Union Hospital, China
申办方类型
Other
责任方
Sponsor

研究点 (1)

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