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临床试验/NCT04494217
NCT04494217已完成不适用

The Influence of Phototherapy Lights on the Measurement of Oxygen Saturation With Pulse Oximeter in Newborns.

Hacettepe University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年9月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

H. Tolga Çelik

MD, Assistant Professor in Neonatology

Hacettepe University

研究点 (1)

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