Product Validation Study of RightSpot Infant pH Indicator for Rapid Bedside Verification of Proper Nasogastric (NG) Tube Placement in Newborn Intensive Care (NICU) Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To determine the percentage of samples obtained by the RightSpot pH Indicator that could have been used to assist in determining proper placement of the NG tube prior to use. (% of collected samples vs. uncollected)
研究概览
简要总结
Objectives:
- To validate the accuracy of pH measurements of gastric fluid by comparing the readings from the RightSpot Infant pH Indicator to a standard clinically approved pH monitor
- To determine what percentage of time the RightSpot Infant pH Indicator could have been used to determine the proper placement of the NG tube prior to feedings
- To establish normative pH values for neonates
详细描述
RightBio Metrics has developed an indicator that rapidly checks gastric pH by aspirating gastric contents into the indicator through a nasogastric (NG) or orogastric (OG), causing a color change on the indicator. The color change represents various pH levels. Most Newborn Intensive Care Units require that NG/OG placement be confirmed after initial insertion and prior to any use. The purpose of this study is to validate the accuracy of pH measurement of gastric fluid by comparing the reading from the RightSpot Infant pH Indicator to a standard clinically approved pH monitor, and to determine what percentage of time the RightSpot Infant pH Indicator could have been used to determine the proper placement of the NG/OG tube prior to use. The gastric pH measurements will be analyzed to determine the normative pH values for neonates.
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
- 24 Weeks 至 40 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants in the Newborn Intensive Care Unit with an NG Tube
排除标准
- •Infants with congenital or genetic abnormalities
- •Infants with gastroschesis
- •Infants with upper airway abnormalities
- •Infants receiving any supplement or medication know to alter pH gastric contents
- •Infants receiving Enfamil liquid human milk fortification
- •Infant who are NPO status
结局指标
主要结局
To determine the percentage of samples obtained by the RightSpot pH Indicator that could have been used to assist in determining proper placement of the NG tube prior to use. (% of collected samples vs. uncollected)
时间窗: 12 weeks
To determine the percentage of samples obtained by the RightSpot pH Indicator that could have been used in determining proper placement of the NG tube prior to use.(% of sample accuracy)
时间窗: 12 weeks
To compare the gastric pH measurement obtained from the RightSpot Indicator to the gastric pH measurement obtained from an approved pH monitor to determine the agreement and accuracy of the two modes of measurements.
时间窗: 12 weeks
The gastric pH measurements will be collected and analyzed to determine the normative pH values for neonates
时间窗: 12 weeks
次要结局
- Adjusted gestational age at the time of testing(12 weeks)
- Infants weight at the time of testing(12 weeks)
- Gestation age at birth(12 weeks)
- Residual amount (ml) at the time of testing(12 weeks)
- Medications given which effect pH of gastric contents(12 weeks)
- Time infant last ate(12 weeks)
- pH reading from gastric secretions(12 weeks)