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临床试验/NCT04386265
NCT04386265Unknown不适用

The Compassionate Use of Hyperbaric Oxygen Therapy in the Treatment of COVID-19

SerenaGroup, Inc.11 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2020年4月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
11
主要终点
Gather information on patients treated with hyperbaric oxygen therapy

研究概览

简要总结

This is an observational patient registry of COVID-19 patients treated with HBOT.

详细描述

The retrospective analysis will focus on the reduction in need for mechanical ventilation in COVID-19 patients. The information will be gathered prospectively. Data will be collected from the patients' medical record, including medical notes and data recorded into the study database.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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 patients with COVID-
  • The clinical decision to use HBOT is independent of the decision to participate in registry.
  • A signed and dated informed consent form for the off-label use of Hyperbaric Oxygen Therapy specific to the institution where treatment is rendered.
  • Subject is willing and able to comply with instructions and scheduled visits.

排除标准

  • The Subject has other concurrent conditions that in the opinion of the Investigator may compromise patient safety.
  • The patient has an untreated pneumothorax.

结局指标

主要结局

Gather information on patients treated with hyperbaric oxygen therapy

时间窗: 24 months

Collect information on the reduction in need for mechanical ventilation in COVID-19 patients.

次要结局

  • Gather information on adverse events(24 months)

研究者

申办方类型
Network
责任方
Sponsor

研究点 (11)

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