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临床试验/EUCTR2019-000857-29-DK
EUCTR2019-000857-29-DK进行中(未招募)1 期

Hyperbaric oxygen treatment in humans with Gram Positive Cocci endocarditis

Rigshospitalet - University Hospital of Copenhagen0 个研究点目标入组 10 人开始时间: 2019年3月14日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
10

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1)Left sided IE with gram positive cocci.
  • 2)IE has been diagnosed according to modified Duke Criteria.
  • 3)Patients must be stable, by means of no need for hemodynamic pressure support.
  • 4)The patient must be able to be seated for the 1.5 hour the HBOT at least two times a day for 3 days.
  • 5)The patient must be able to perform Valsalva’s – or Frenzels manoeuvre – to equalize middle ear pressure. As prophylaxis, all patients will receive detumescent nose drops as Otrivin® to facilitate ear- and sinuses equilibration. In the rare event it is still not possible for the patient to equalize pressure, a paracentesis or drainage of the tympanic membrane must be performed by the ENT doctor. All according to daily practice.
  • 6)The upstart of HBOT must be within the first week of relevant antibiotic IE therapy.
  • 7)If a central venous catheter has been inserted, a chest X-ray must confirm no suspicion of pneumothorax.
  • 8)Patients must be >18-years old.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 7
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 3

排除标准

  • 1)Claustrophobia that cannot be reversed by mild sedatives.
  • 2)Patients requiring mechanical ventilation.
  • 3)Undrained pneumothorax
  • 4)Pregnancy
  • 5)Unable to follow and understand simple commands
  • 6)Non-compliant

研究者

发起方
Rigshospitalet - University Hospital of Copenhagen

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