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临床试验/NCT06239610
NCT06239610已完成不适用

DrIFT 2 Study: Displacement in Feeding Tubes

Parkview Health2 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2024年3月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
119
试验地点
2
主要终点
Tube Migration

研究概览

简要总结

The proposed study will use an electromagnetic placement device (EMPD), Cortrak* 2 Enteral Access System (EAS™), Avanos Medical, to verify feeding tube (FT) position on a daily basis to assess for migration. The EMPD provides real-time FT placement data. A sensor located on the distal end of the FT guidewire communicates with a receiver unit which sits on the patient's abdomen. Three visual insertion tracings with varying views (anterior, lateral, and depth/cross-section) can be saved and printed for comparison.

详细描述

Two previous studies have been completed with similar methodology. A pilot study of 50 subjects was performed using the original Cortrak* (2 insertion views) and found only minimal forward migration. No reverse migration was reported in one study.

A pilot study of 20 patients with 62 feeding tube assessment identified 8 migration events (5 retrograde and 3 forward), these events only occurred within the small bowel. Based on this data, a recommendation could be made that there is no need to check feeding tube placement routinely every four hours. However, due to the small sample size, additional research is needed to confirm this finding. It is also unknown if there may be more migration with positioning changes, for example, up in the chair or prone position.

The proposed study will use an electromagnetic placement device (EMPD), Cortrak* 2 Enteral Access System (EAS™), Avanos Medical, to verify FT position on a daily basis to assess for migration. The proposed study will take place in critical care units at Parkview Health. The primary aim will be to determine if replication of the pilot study results in similar findings. Investigators will also explore other factors that may be associated with FT migration, such as patient mobility (ambulation or sitting at bedside or prone position) and transporting out of the critical care unit for diagnostic procedures. Researchers anticipate that results from this study will provide a better understanding of FT position and migration over time and ultimately influence recommendations for practice for frequency of routine FT verification. Standard of care for assessing feeding tube placement location every 4 hours will remain in place. The study will add an additional assessment for feeding tube location daily. This study will expand on the findings from the initial pilot study with a larger sample size.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

入选标准

  • Adult critical care patients with small bore feeding tube inserted within last 24-48 hours
  • Initial Cortrak insertion tracings: all 3 views available
  • Cortrak guidewire available

排除标准

  • Unable to speak or understand English language
  • Pregnancy
  • Prisoners
  • FT anticipated to be removed within 24 hours
  • Contraindications to placing a mark on the abdomen for top foot of receiver unit (large dressings, open abdomen, halo vest, etc.)
  • Original guidewire unavailable

结局指标

主要结局

Tube Migration

时间窗: 5 days or until FT removed, whichever came first

Number of participants with clincially significant feeding tube retrograde migration

Effect of ETT Extubation on FT Movement

时间窗: 5 days or until FT removed, whichever came first

Number of participants with clincially significant retrograde migration after extubation

次要结局

未报告次要终点

研究者

发起方
Parkview Health
申办方类型
Other
责任方
Principal Investigator
主要研究者

Danielle Payne, FNP

Clinical Nurse Researcher & Nursing Research Program Coordinator

Parkview Health

研究点 (2)

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