Detection of Atelectasis or Pneumothorax and Resolution With Electrical Impedance Tomography (EIT) in Newborn Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Pneumothorax: Change in measured % Unventilated Lung between TimePeriods (t1 and t2)
研究概览
简要总结
To validate the benefits of recognizing asymmetric lung disease like atelectasis and pneumothorax in neonatal respiratory distress syndrome using electrical impedance tomography
详细描述
To quantify the changes in regional lung air content associated with the variations of the respiratory support settings, the following approach will be used. The changes in local air content will be determined in the selected EIT region of interest (ROI) in terms of a change in local average lung density and relative impedance change with respect to a reference air content.
- TimePeriod 1 (t1): The reference lung air content will be measured once the asymmetric lung disease is identified on chest x-ray.
- TimePeriod 2 (t2): A post-lung disease EIT measurement will be obtained at 6-24 hours later or immediately after clinical therapy (i.e. chest tube placement or needle decompression), whichever occurs first.
Eligible infants with confirmed asymmetric lung disease (atelectasis or pneumothorax) by radiographic images requiring no respiratory support or on mechanical support or nCPAP therapy of 5-8 cm H20 achieved with a ventilator, an underwater "bubble" system, or a variable-flow device will be enrolled. All of these methods of providing the therapy are done with FDA approved devices currently used in the NICU.
EIT data will be acquired using The LuMon Monitor-Neo, GUI software 1.0.x.x/TIC software 1.6.x.xxx (SenTec, Landquart, Switzerland). The EIT system will be placed at the subject's bedside to collect EIT measurements: Ventilation distribution%, changes in regional aeration in arbitrary units (AU), dependent and non-dependent silent spaces.
A data acquisition cart will also be placed at the subject's bedside to collect hemodynamic and respiratory parameters measurements including: Heart rate (HR), blood pressure (BP), respiratory rate (RR), fraction of inspired oxygen (FiO2), transcutaneous carbon dioxide (TcCO2), and peripheral oxygen saturation (SpO2) via bedside monitoring devices.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All infants admitted to the NICU at SMBHWN
- •Informed consent obtained
- •Atelectasis confirmed on CXR
- •Pneumothorax confirmed on CXR
排除标准
- •Declined consent
- •Infants with known congenital anomalies
研究组 & 干预措施
Atelectasis or Pneumothorax
Infants with asymmetric lung disease (i.e. atelectasis or pneumothorax) confirmed by chest radiograph
干预措施: Detecting asymmetric lung disease like atelectasis or pneumothorax with electrical impedance tomography (EIT) (Other)
结局指标
主要结局
Pneumothorax: Change in measured % Unventilated Lung between TimePeriods (t1 and t2)
时间窗: Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery
To determine pneumothorax is the percentage of lung areas with non-negligible impedance change during breathing.
Atelectasis: Change in measured % Unventilated Lung between TimePeriods (t1 and t2)
时间窗: Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery
Atelectasis will be calculated using the percentage of the lung fields that are not engaged in tidal volume.(VT)
次要结局
- Geometric Center of Ventilation (CoV)(Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery)
- Change in % of total tidal volume (VT) within 8 lung regions(Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery)
- Relative change in uncalibrated aeration (end-expiratory lung volume)(Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery)
- Regional distribution of tidal volume(Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery)
- Change in Global Inhomogeneity (GI) index between t1 and t2(TimePeriod 1 (t1): at time of radiographic diagnosis of atelectasis/pneumothorax; TimePeriod 2 (t2): 6-24 hours after t1 or immediately after clinical therapy (e.g., chest tube placement/needle decompression), whichever occurs first.)
研究者
Anup Katheria, M.D.
Director Neonatal Research Institute
Sharp HealthCare