Evaluation of RightBio Metrics', RightSpot pH Indicator, for Rapid Bedside Verification of Proper Nasogastric/ Orogastric Tube Placement in Emergency Department & Intensive Care Unit Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Determination of proper placement of ng/og tube
研究概览
简要总结
This study will evaluate the use of RightBio Metrics' RightSpot device used to determine if there is proper placement of a nasogastric or orogastric tube.
详细描述
Primary objective:
To assess the level of accuracy of the RightSpot pH Indicator in determining correct placement of NG/OG tubes as compared to the gold standard of CXR in Emergency Department & ICU patients.
Hypothesis 1: In greater than 90% of the cases, RightSpot pH Indicator will be successful in confirming the placement of NG/OG tubes by demonstrating a pH of 4.5 or less in patients with CXR proven tube placement.
Hypothesis 2: The time to confirmation of NG/OG tube placement will be significantly less using the RightSpot pH Indicator than using CXR. The time will be calculated by the start time consisting of the time that the NG/OG tube was placed until the end time, which will be when the device pH Indicator testing is performed. The time to confirmation using the gold standard of a CXR will begin when the NG/OG tube is placed and end when the CXR is available on PACS (picture archiving and communication system).
Secondary objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years and older
- •Patient or proxy willing to provide informed consent
- •Patients who require placement of a nasogastric/orogastric tube, in the ED or ICU, as standard of care, AND a member of the study staff is available and present for NG/OG tube placement.
- •It is anticipated that the patient will remain in the ED/ICU in order to obtain RightSpot pH Indicator reading and verifying CXR
排除标准
- •Patients less than 18 years of age
- •Patient or proxy unwilling or unable to provide informed consent
- •Patient with known or suspected pregnancy
结局指标
主要结局
Determination of proper placement of ng/og tube
时间窗: Participants will be followed until the determination of proper placement of the ng/og tube is made. This is anticipated to be less than 3 hours.
The pH will be assessed by visual inspection of pH paper within the device. If the pH is noted to be less than 4.5 then the placement will be considered to be within the stomach.
次要结局
- Confounding factors for using the RightSpot pH Indicator(Participants will be followed until the determination of proper placement of the ng/og tube is made. This is anticipated to be less than 3 hours.)
- Time to confirmation of tube placement(Participants will be followed until the determination of proper placement of the ng/og tube is made. This is anticipated to be less than 3 hours.)