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临床试验/NCT06373224
NCT06373224终止不适用

Evaluating the Use of Preventive Cold Saline to Decrease Bleeding Associated With Endobronchial Biopsy

TriHealth Inc.1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2023年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
6
试验地点
1
主要终点
Unreadable Biopsy Slides

研究概览

简要总结

Patients undergoing an endobronchial ultrasound and biopsy can experience bleeding during the biopsy. These biopsies are read in real time by pathologists who travel to the endoscopy unit during the procedure. Often, when this happens, the blood contaminates the pathology slides making the slide unreadable. This then requires more biopsies to be performed, thus prolonging the procedure, and increasing anesthesia time. One innovative way to reduce bleeding may be to irrigate the bronchial wall with cold saline, where the biopsy is to be taken, immediately before biopsy, thus causing vasoconstriction and possibly resulting in less blood contamination on the biopsy slides. The current study will evaluate this prophylactic irrigation with saline to control bleeding, thus resulting in a quicker diagnostic result of the biopsies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

  • •Undergoing an endobronchial ultrasound and biopsy at Bethesda North Hospital

排除标准

  • •Under 18 years old
  • •Does not speak English
  • •Unable to consent to involvement in the research study
  • •Is pregnant
  • •Has a bleeding disorder/diagnosis
  • •Currently taking anticoagulant medications and not stopped for procedure
  • •Documented low platelets (<100,000)
  • •Had a biopsy taken immediately prior to the endobronchial ultrasound

研究组 & 干预措施

Flush Group

Experimental

After identifying the lymph node or lesion to be biopsied on ultrasound, using the endobronchial ultrasound scope, two 60mL syringes of cold saline will be inserted, through the biopsy channel of the endobronchial ultrasound scope, directly onto the bronchial wall where the biopsies are to be performed. The saline will then be sucked out of the airway using the endobronchial ultrasound scope.

干预措施: Flush (Other)

Standard Care Group

No Intervention

No irrigation before the biopsy

结局指标

主要结局

Unreadable Biopsy Slides

时间窗: from enrollment until discharge from biopsy appointment, up to 12 hours

cumulative number of unreadable slides across all biopsy slides noted by the pathologist to be unreadable due to blood on slide

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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