跳至主要内容
临床试验/NCT05661773
NCT05661773撤回不适用

Assessing the Effect of Vacuum Suction on Digital Ischemia in Critically Ill Patients

Wake Forest University Health Sciences0 个研究点开始时间: 2023年11月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Incidence of digital ischemia

研究概览

简要总结

Patients requiring high dose pressors (minimum 2) who are unlikely to be weaned off them over 1 day will be identified. Patients will have the device applied to one hand while expectant medical management will continue to the contralateral hand.

详细描述

The proposed study offers no foreseeable risk to patients. The device relies on a wound vac system for vacuum generation which is industry standard and approved for creating safe suction applied to wounds. In this application, the same suction and device would be used to apply suction to an enclosure through which the hand is placed. Similarly, a heat exchanger would be used to run lukewarm water through a warming bad, which is technology that is routinely used in surgery. Heater coolers are used in every bypass surgery, and warming fluid blankets are common for helping to rewarm patients on the operating room table.

研究设计

研究类型
Interventional
分配方式
Non 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

入选标准

  • Patients in the cardiac critical care unit/cardiovascular intensive care unit with cardiac pathologies on vasopressor support

排除标准

  • Patients who are not on vasopressor support
  • Patients under the age of 18

结局指标

主要结局

Incidence of digital ischemia

时间窗: Day 14

rate of digital ischemia characterized by tissue loss or destruction - measure incidence rate as a ratio of patients who got digital ischemia with the number of patients who were on vasopressors

次要结局

  • extent of digital ischemia - length of digits involved(Day 14)
  • extent of digital ischemia - number of digits involved(Day 14)

研究者

申办方类型
Other
责任方
Sponsor

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