Post-hoc Analysis of Regional Pulmonary Perfusion and Hemodynamic Parameters Measured by Electrical Impedance Tomography
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Assess regional distribution of pulmonary perfusion
研究概览
简要总结
Define the capability and reliability of the PulmoVista® 500 (PV500) to detect changes in global and regional ventilation and perfusion.
详细描述
The results of this study will help defining the capability and reliability of PulmoVista® 500 (PV500) to detect changes in both global and regional ventilation and perfusion. As this is a non-invasive, observational trial, neither a positive nor a negative impact on the actual study participants is expected. The results will, however, improve the knowledge about the electrical impedance tomography (EIT) technology and thus aid the use of this technology for the benefit of future patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Age 18 - 80 years
- •Mandatorily ventilated intensive-care patients with impairment in oxygenation (P/F ratio < 300 at PEEP ≥ 5) ventilated at a positive end-expiratory pressure (PEEP) not exceeding 10 mbar and an fraction of inspired oxygen (FiO2) chosen, such that pulse oximetry is sensitive towards arterial oxygen pressure (PaO2) changes.
- •Expected ventilation time >48h
- •Existing central venous and arterial access
- •Chest circumference 70 - 150 cm
- •Mandatory mechanical ventilation (patients without spontaneous efforts)
- •Serum levels of sodium and chloride within normal range
- •Cardiac output monitoring in place (PICCO)
排除标准
- •Contraindication to central venous injection of 5 % sodium chloride (NaCl) (e.g. elevated Na+ and/or Cl- concentration: Na+ should not exceed 150 mmol/l, Chloride should not exceed 115 mmol/l, known hypernatremia, known high serum osmolality)
- •Contraindications of PulmoVista 500:
- •Patients with pacemakers, defibrillators or other electrically active implants
- •Patients with damaged skin or impaired skin contact of the electrodes due to wound dressings
- •Patients where the attachment of the patient belt could pose a risk to the patient, e.g. patients with spinal lesions or fractures
- •Patients with uncontrolled body movements
- •Extremely obese patients (BMI>50)
- •Patients during pregnancy
- •Patients with massive lung edema
- •Use during electricity-based therapies, such as electrosurgery or electrocautery
- •Use in the presence of strong magnetic fields
- •Use in conjunction with other bioimpedance measurement devices
- •Infection or colonization with multi-resistant pathogens that require isolation of the patient (e.g. MRSA)
结局指标
主要结局
Assess regional distribution of pulmonary perfusion
时间窗: within 24 hours
The capability of PulmoVista® 500 for assessing regional distribution of pulmonary perfusion based on pulsatility signals and based on indicator dilution and changes at different points in time during varying states of regional ventilation will be evaluated.
次要结局
- Assess hemodynamic parameter heart rate(within 24 hours)
- Assess hemodynamic parameter cardiac output(within 24 hours)
- Assess hemodynamic parameter stroke volume variability(within 24 hours)
- Assess oxygenation status(within 24 hours)