The Influence of Phototherapy Lights on the Measurement of Oxygen Saturation With Pulse Oximeter in Newborns.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percent Oxygen Saturation Before and During Covering Oximeter Probe
研究概览
简要总结
This will be a prospective clinical study conducted with the approval of the Clinical Research Ethics Committee.
The influence of phototherapy lights on the accuracy of pulse oximetry will be investigated.
详细描述
Each patient's oxygen saturation will be measured non-invasively via a nondisposable polyethylene neonatal probe taped to the infant's palm, toe, or dorsum of the foot. The probe will be connected to an Massimo Rad97 pulse oximeter that is standardized at the factory. It runs through an automatic systems check when turned on and needs no further calibration before being used. The oxygen saturation measurements will be considered valid when there will be a normal plethysmographic waveform, a fullscale signal strength bar, and a stable heart rate closely approximating an independent electrocardiographic (ECG) pulse rate. The pulse oximeter works by using the technology of plethsmography which allows the detection of an arterial pulse) with oximetry (which measures oxygen saturation at specific wavelengths). The pulse oximeter will be placed on each infant as already described. After a stable pulse oximeter reading was obtained, the value will be recorded ("before") and then the probe will be covered with a standard disposable diaper, shiny side up. When the reading stabilized, the value will be recorded ("during") and then the diaper will be removed.
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
- •newborn babies (0-28 days)
- •to be treated in the Hacettepe University Children's Hospital Neonatal Intensive Care Unit
- •receiving phototherapy treatment
排除标准
- •Newborn babies with any diseases that affect oxygen saturation including congenital heart disease, chromosomal disease, inborn error of metabolism, anemia, circulatory disorder, hypovolemia or hydrops fetalis
结局指标
主要结局
Percent Oxygen Saturation Before and During Covering Oximeter Probe
时间窗: The two data (''before'' and ''during'') will be recorded consecutively for each infant, when the reading stabilize. All measurements will be completed wiithin 6 months according to the study protocol calendar.
The two data points (percent oxygen saturation before and during covering of oximeter probe) for each patient will be compared.
次要结局
未报告次要终点
研究者
H. Tolga Çelik
MD, Assistant Professor in Neonatology
Hacettepe University
