NCT05640973撤回不适用
Clinical Usability of a Novel Non-Adhesive Applicator for the Monitoring of tcPCO2 in Neonates
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Clinical Usability of a Novel Non-Adhesive Applicator for the Monitoring of tcPCO2 in Neonates
研究概览
简要总结
Subjects that are currently on a transcutaneous carbon dioxide monitor (TCOM) to monitor the carbon dioxide level in their blood will be placed on an additional TCOM using a non-adhesive sensor application ring instead of the usual adhesive ring to hold the TCOM sensor in place in order to evaluate usability of the non-adhesive applicator.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 5 Minutes 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Premature or term birth newborn infants requiring transcutaneous monitoring
- •Thigh circumference of greater than 63mm
- •Weight greater than or equal to 600g
- •Ability of caretaker to understand verbal and written instructions and informed consent
排除标准
- •Absence of written informed consent.
- •Skin condition contraindicating transcutaneous measurements.
- •Thigh circumference less than or equal to 63 mm
结局指标
主要结局
Clinical Usability of a Novel Non-Adhesive Applicator for the Monitoring of tcPCO2 in Neonates
时间窗: 3 Months
次要结局
未报告次要终点
研究者
Ann Donnelly
Principal Investigator
Milton S. Hershey Medical Center
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