Intrapulmonary Volume Changes During Synchronized Noninvasive Positive Pressure Ventilation In Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Tidal volume (VT)
研究概览
简要总结
Current evidence suggests that noninvasive positive pressure ventilation (NIPPV) is more effective than continuous positive airway pressure (CPAP) in preventing respiratory failure in preterm infants with respiratory distress syndrome (RDS), both as initial and post-extubation support. NIPPV may be delivered in synchronized (sNIPPV) or non-synchronized (nsNIPPV) modes, with sNIPPV offering clear benefits by coordinating support with the infant's own breathing. Recent studies indicate sNIPPV is superior to nsNIPPV in preventing respiratory failure, though the intrapulmonary mechanisms behind this advantage remain unclear. To address this, the present study uses Electrical Impedance Tomography (EIT) to evaluate how lung volume changes during different types of breaths and ventilator inflations - spontaneous breaths, synchronized inflations, non-synchronized inflations, and backup inflations - in preterm infants receiving sNIPPV.
详细描述
Hypothesis:
Synchronized inflations during NIPPV will increase tidal volumes (VT) and lung aeration when compared with non-synchronized inflations. Pressure peaks delivered during expiration (non-synchronized inflations), between spontaneous breaths (backup inflations), or during periods of apnea (backup inflations) will not increase relative VT.
Primary objective:
The primary objective is to assess lung volume changes between spontaneous breaths and synchronized inflations, non-synchronized inflations, and backup inflations using EIT.
Secondary objectives:
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
- — 至 4 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent by one or both parents or legal guardians
- •Gestational age at birth < 30 0/7 weeks
- •Infants on sNIPPV respiratory support
- •Below 4 weeks chronological age
排除标准
- •Severe congenital malformation adversely affecting lung aeration or perfusion (e.g., congenital heart defects)
- •Too ill/unstable in the opinion of the treating physician.
结局指标
主要结局
Tidal volume (VT)
时间窗: At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.
Difference in relative VT (rel. ΔZ) between spontaneous breaths and synchronized inflations.
次要结局
- Oxygen supplementation(Continuous measurement during the 180-minute recording period.)
- Global lung impedance(At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.)
- Regional tidal volume distribution(At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.)
- Center of ventilation(At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.)
- Silent spaces(At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.)
- Global inhomogeneity index(At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.)
- Coefficient of variation(At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.)
- Inspiratory time(At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.)
- Expiratory time(At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.)
- Lung ultrasound score(Immediately before the first infant handling as well as following electrical impedance tomography belt removal.)
- Heart rate(Continuous measurement during the 180-minute recording period.)
- Peripheral oxygen saturation(Continuous measurement during the 180-minute recording period.)