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临床试验/NCT01825564
NCT01825564终止不适用

Comparison of the RightSpot pH Indicator & RightLevel pH Detector With the Gold Standard of Radiographic Verification of Feeding Tube Placement & Gastrostomy Tube Replacement

St. Louis University1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2013年3月14日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
11
试验地点
1
主要终点
pH measurement of gastric or duodenal secretions

研究概览

简要总结

Replacing a G tube and placing feeding tubes is standard in the Emergency Department (ED) and ICU, respectively. However placement requires a chest or abdominal x-ray to confirm correct position. The investigators are testing the accuracy of the FDA approved devices RightSpot pH Indicator & RightLevel pH Detector in determining correct position based upon pH which will then be correlated with the standard of care x-ray.

详细描述

Feeding tube placement is a common procedure that occurs in most ICU healthcare settings. In addition, replacement of G-tubes is a common practice in most ED settings throughout the US. Various practices have been used to confirm its placement, including the usage of litmus paper (acid versus base only), pH level indicators (precise measurement), auscultation, bubbling method, aspirate appearance, chest radiography (CXR) and gastrografin .

Review of data in numerous studies has revealed that many of these techniques may not provide fully accurate results, possibly leading to the potential for patient injuries, and even fatal complications. Auscultation, bubbling method, and aspirate appearance have been demonstrated to provide findings that can be misinterpreted and cause false assurance of correct placement. Several deaths and serious injuries have been attributed to the use of litmus paper in verification of feeding tube placement and subsequent utilization of the tube as well as G-tube replacement. Consequently, litmus paper is no longer considered to be a safe and effective confirmatory test for feeding tube placement or G-tube replacement.

Currently, the gold standard for verification of feeding tube placement is CXR or abdominal x-ray and G-tube replacement in an acute care setting is abdominal x-ray with gastrografin. This method is time-consuming, costly, and results in an increase in patient exposure to radiation. In addition for a patient who resides outside of the hospital setting at the time of needed G-tube replacement there is additional costs of transport to and from the ED. An alternative to CXR is measurement of gastric content pH level. This is a confirmed and valid tool for nasogastric/orogastric (NG/OG) verification and a recognized replacement of the litmus paper test.A pH level of 4.5 or less has been validated to indicate presence of gastric contents. A drawback to the use of typical pH indicators alone is that they require fluid aspirate to be placed manually onto the indicator surface. This increases the risk of exposure to bodily fluids for medical personnel. Thus, the ideal device to determine accurate feeding tube placement and G-tube replacement is one that will precisely measure the acid (pH) level of aspirate and significantly reduce the risk of bodily fluid exposure.

The RightSpot pH Indicator & RightLevel pH Detector are devices which purport to meet both of these criteria. Both can provide an accurate pH level. The pH paper is encased in a protective exterior that can be attached directly to a syringe, thus, decreasing the likelihood of accidental exposure.

This study will evaluate the use of this novel device to accurately verify feeding tube placement in an ICU care setting and G-tube replacement (of foley catheter) by measuring the pH and comparing this with gastrografin radiographic confirmation.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age older than 18
  • Requirement for placement of a feeding tube or a G-tube replacement
  • Patient or proxy able to provide informed consent
  • English proficiency of person providing informed consent

排除标准

  • Patients that are younger than the age of 18
  • Inability to obtain consent
  • Grossly bloody aspirate
  • Pregnancy

结局指标

主要结局

pH measurement of gastric or duodenal secretions

时间窗: Within 24 hours of tube insertion prior to the initiation of tube feeding

The pH measurement obtained will be used to determine correct placement of the gastric or feeding tube as compared to the gold standard method of X-ray following gastrograffin administration

次要结局

  • Costs associated with G-tube reinsertion in the Emergency Department(Within 2 weeks of Discharge from the Emergency Department)

研究者

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

Timothy Havens, MD

Assistant Professor

St. Louis University

研究点 (1)

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