Preterm Neonate/ Neonatal Embedded Universal Microelectronic Wearable Acquisition for Cardio Respiratory Intensive Therapy. Clinical Assessment of Device Usability and Reliability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Proportion (%) of recording time with high quality EIT-signal
研究概览
简要总结
The usability of a new PNEUMACRIT system is studied in clinical environment in this feasibility study.
详细描述
Electrical impedance tomography is a noninvasive monitoring tool for neonatal lung aeration and breathing. This feasibility study will assess the usability of a new PNEUMACRIT electrode belt in clinical environment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Hours 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatient at Oulu University Hospital PICU or NICU
- •Gestational age at birth over 32 weeks
- •Weight 2000-5000g
- •Postnatal age > 12 hours
- •Written informed consent from the parents of legal representative
- •Non-invasive monitoring of oxygen saturation and ECG
排除标准
- •Postmenstrual age < 32 weeks
- •Weight at time of the study < 2000g or > 5000g
- •Chest skin lesion preventing safe use of the electrode belt
- •Recent chest surgery within the past 7 days (e.g. thoracotomy)
研究组 & 干预措施
Feasibility of the PNEUMACRIT belt
Neonates will be monitored with a PNEUMACRIT electrode belt for 6 to 24 hours. After the study period, patient parents and nurses will give feedback.
干预措施: PNEUMACRIT (Device)
结局指标
主要结局
Proportion (%) of recording time with high quality EIT-signal
时间窗: 6-24 hours
Proportion of time that the collected EIT signal is accurate enough for reliable image reconstruction and observations of changes in lung aeration
次要结局
- Staff and parent questionnaires(48 hours)
研究者
Merja Kallio
MD, PhD, Principal investigator, Associate professor of pediatrics
University of Oulu