Electrical Impedance Tomography for Identification of Optimal Positive End-expiratory Pressure in Newborn Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Change in Silent Spaces (areas of atelectasis as well as overdistension)
研究概览
简要总结
Electrical impedance tomography (EIT) enables assessment of regional lung ventilation at the bedside. EIT has been safely used in newborn infants to image intrathoracic lung volume patterns as early as from the first minute of life. This prospective single-centre observational study is to identify optimal PEEP in infants on respiratory support by measurements of EIT, FOT and SOPI.
详细描述
Evidence-based guidelines on the optimal level of positive end-expiratory pressure (PEEP) in newborn infants on respiratory support do not exist. Furthermore, there is a lack of simple bed-side parameters to guide clinicians towards the optimal PEEP level. Nevertheless, PEEP requires individual adjustment to minimize ventilator induced lung injury (VILI), shorten the duration of mechanical ventilation and reduce respiratory long-term morbidity.
Potential techniques to assess optimal PEEP level in infants on respiratory support include electrical impedance tomography (EIT), the forced oscillation technique (FOT) and the saturation oxygenation pressure index (SOPI). EIT is a promising non-invasive technique that provides information on regional changes in lung aeration and ventilation inhomogeneity. FOT is used in mechanically ventilated or spontaneously breathing infants and provides information on reactance (Xrs) and resistance (Rrs) of the respiratory system. SOPI is a score calculated from the PEEP level, the amount of administered oxygen (FiO2) and the infant's peripheral oxyhaemoglobin saturation (SpO2). SOPI provides information on the ventilation to perfusion ratio dependent on the PEEP level. EIT, FOT and SOPI seem promising tools for identification of optimal PEEP in newborn infants on respiratory support. In particular, a combination of information on regional ventilation (by EIT), global lung mechanics (by FOT) and ventilation to perfusion ratio (by SOPI) will improve the understanding of optimal PEEP and may reduce long-term respiratory sequelae.
This prospective single-centre observational study is to identify optimal PEEP in infants on respiratory support by measurements of EIT, FOT and SOPI. Measurements are performed once daily during the first three days on respiratory support and are repeated in weekly intervals if the infant remains mechanically ventilated. An additional measurement is planned after extubation.
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
- 0 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •22+0 to 41+6 weeks' gestational age
- •Requiring mechanical ventilation
- •Written informed parental consent
排除标准
- •Major congenital malformations including lung and cardiac malformations
- •Infants on high frequency oscillatory ventilation
- •Lack of written informed parental consent
结局指标
主要结局
Change in Silent Spaces (areas of atelectasis as well as overdistension)
时间窗: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)
Silent Spaces measured by EIT (calculated from electrical impedance)
Change in composite score consisting of proportionally weighted raw values of Silent Spaces, Xrs and SOPI (mechanical ventilation)
时间窗: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)
A composite score consisting of proportionally weighted raw values of Silent Spaces, respiratory reactance (Xrs) and SOPI (mechanical ventilation)
Change in Saturation oxygenation pressure index (SOPI)
时间窗: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)
Calculated from standard monitoring parameters such as PEEP, fraction of inspired oxygen pressure (FiO2) and peripheral oxyhaemoglobin saturation (SpO2) (PEEP x FiO2 x 100) / SpO2)
Change in composite score consisting of proportionally weighted raw values of Silent Spaces and SOPI (non-invasive respiratory support)
时间窗: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)
A composite score consisting of proportionally weighted raw values of Silent Spaces and SOPI (non-invasive respiratory support)
Change in respiratory reactance (Xrs) (measure of compliance of the respiratory system)
时间窗: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)
Respiratory reactance reflects inertance and compliance of the lungs and can be viewed as rebound resistance
次要结局
- Change in resistance (Rrs) of the respiratory system(Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month))
- Change in tidal volume per kg body weight (VT/kg)(Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month))
- Change in dynamic compliance(Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month))
- Change in Delta impedance (ΔZ)(Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month))
- Change in centre of ventilation (CoV)(Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month))
- Change in tidal volume (VT,EIT)(Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month))
- Change in transcutaneous CO2 pressure (tcpCO2)(Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month))
- Change in peak inspiratory pressure(Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month))
- Change in driving pressure of the respiratory system (Peak plateau pressure - PEEP)(Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month))
- Change in respiratory rate(Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month))