Flow Versus Pressure Controlled Ventilation in Patients With Moderate to Severe Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Mechanical power
研究概览
简要总结
The goal of this clinical trial is to compare flow-controlled ventilation (FCV) and pressure-controlled ventilation (PCV) in patients with moderate to severe acute respiratory distress syndrome on the intensive care unit.
The main questions it aims to answer are:
- Is the mechanical power during flow-controlled ventilation lower than during pressure-controlled ventilation
- To gain more understanding about other physiological effects and potential benefits of flow-controlled ventilation in comparison to pressure-controlled ventilation (o.a. the end-expiratory lung volume and homogeneity of ventilation).
Participants will be randomized between two ventilation mode sequences, being 90 minutes of FCV followed by 90 minutes of PCV or vice versa.
详细描述
Rationale: During controlled mechanical ventilation (CMV) only the inspiration is controlled by either a set driving pressure (Pressure Controlled Ventilation, PCV) or tidal volume (Volume Controlled Ventilation, VCV). The expiration depends on the passive elastic recoil of the respiratory system and cannot be controlled and lasts until the airway pressure is equal to the positive end-expiratory pressure (PEEP). The exponential decrease in airway pressure during expiration may result in alveolar collapse and hypoxemia. Flow controlled ventilation (FCV) is a mechanical ventilation method that uses a constant flow during both inspiration and expiration. FCV results in a gradual decrease in airway pressure during expiration as flow is controlled. In both animal and prospective crossover studies, controlled expiration resulted in higher mean airway pressures with reduced alveolar collapse. Besides, FCV resulted in a higher ventilation efficiency measured by a decrease in minute volume at stable arterial partial pressures of carbon dioxide (PaCO2). Where a reduction in alveolar collapse may lead to less atelectrauma, a higher ventilation efficiency may lead to a lower mechanical power (MP), which is the amount of energy (Joules) that is transferred to the respiratory system by the mechanical ventilator every minute. Both are important determinants of Ventilator Induced Lung Injury (VILI). This makes FCV a very interesting ventilation mode in patients with the acute respiratory distress syndrome (ARDS) in which VILI is still a major contributor to overall morbidity and mortality. Two prior prospective cross-over studies have been performed in (COVID-19) ARDS patients that did show a lower minute volume with FCV compared to PCV or VCV. However, these studies did not take into account assessments of the MP or end-expiratory lung volume (EELV), which is a measurement of lung aeration.
The investigators hypothesize that FCV in patients with moderate to severe ARDS results in a lower MP and an increased EELV compared to standard CMV modes (PCV or VCV).
Objectives: To study the effect of FCV on the MP and the EELV compared to PCV.
Study design: Randomized crossover physiological pilot study comparing FCV and PCV.
Study population: Patients with moderate to severe ARDS ≥ 18 years old receiving CMV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- 否
入选标准
- •18 years or older
- •Provided written informed consent
- •Undergoing controlled mechanical ventilation via an endotracheal tube
- •Meeting all criteria of the Berlin definition of ARDS
- •Hypoxic respiratory failure within 1 week of a known clinical insult or new or worsening respiratory symptoms
- •Bilateral opacities on X-ray or CT-scan not fully explained by effusions, lobar/lung collapse (atelectasis), or nodules
- •Respiratory failure not fully explained by cardiac failure or fluid overload.
- •Oxygenation: moderate ARDS P/F ratio between 101-200 mmHg, severe ARDS PF ratio ≤ 100mmHg, both with PEEP ≥ 5 cmH2O.
- •Intubated ≤72 hours
排除标准
- •Severe sputum stasis or production requiring frequent bronchial suctioning (more than 5 times per nurse shift)
- •Untreated pneumothorax (i.e., no pleural drainage)
- •Hemodynamic instability defined as a mean arterial pressure below 60mmHg not responding to fluids and/or vasopressors or a noradrenalin dose >0.5mcrg/kg/min
- •High (>15 mmHg) or instable (an increase in sedation or osmotherapy is required) intracranial pressure
- •An inner tube diameter of 6mm or less
- •Intubated > 72 hours
- •Anticipating withdrawal of life support and/or shift to palliation as the goal of care
- •Inability to perform adequate electrical impedance tomography (EIT) measurements with, e.g.:
- •Have a thorax circumference inappropriate for EIT-belt
- •Thoracic wounds, bandages or deformities preventing adequate fit of EIT-belt
- •Recent (<7 days) pulmonary surgery including pneumonectomy, lobectomy or lung transplantation
- •ICD device present (potential interference with proper functioning of the EIT device and ICD device)
- •Excessive subcutaneous emphysema
- •Contra-indications for nasogastric tube or inability to perform adequate transpulmonary pressure measurements with, e.g.:
- •Recent esophageal surgery
- •Prior esophagectomy
- •Known presence of esophageal varices
- •Severe bleeding disorders
研究组 & 干预措施
FCV-PCV
90 minutes of flow-controlled ventilation followed by 90 minutes of pressure-controlled ventilation.
干预措施: Flow-controlled ventilation (Device)
PCV-FCV
90 minutes of pressure-controlled ventilation followed by 90 minutes of flow-controlled ventilation.
干预措施: Flow-controlled ventilation (Device)
结局指标
主要结局
Mechanical power
时间窗: 90 minutes
Difference in mechanical power in J/min after 90 minutes of flow-controlled ventilation and 90 minutes of pressure-controlled ventilation
次要结局
- P/F ratio(30 and 90 minutes)
- Airway pressures(30 and 90 minutes)
- End-expiratory lung volume(30 minutes)
- Dissipated energy(90 minutes)
- Minute volume(30 and 90 minutes)
- Electrical Impedance Tomography (EIT)(30 and 90 minutes)
- Mean arterial pressure(30 and 90 minutes)
- Pulserate(30 and 90 minutes)
- Transpulmonary pressures(30 and 90 minutes)
- Ventilatory ratio(30 and 90 minutes)
研究者
Henrik Endeman
Principal Investigator
Erasmus Medical Center