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
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