跳至主要内容
临床试验/NCT04332081
NCT04332081终止不适用

Open Label Single-Center Study of Emergency Hyperbaric Oxygen for Respiratory Distress in Patients With COVID-19

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年4月6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
80
试验地点
1
主要终点
Mortality

研究概览

简要总结

Hyperbaric oxygen therapy (HBOT) treatment will be provided to patients as an adjunct to standard therapy for a cohort of 40 COVID19-positive patients with respiratory distress at NYU Winthrop Hospital. All patients prior to the clinical application of HBOT will be evaluated by the primary care team and hyperbaric physician. After the intervention portion of this study, a chart review will be performed to compare the outcomes of intervention patients versus patients who received standard of care.

详细描述

This is a single center prospective pilot cohort study to evaluate the safety and efficacy of hyperbaric oxygen therapy (HBOT) as an emergency investigational device for treating patients with a novel coronavirus, disease, COVID-19. Patients that meet inclusion criteria will be consented by the hyperbaric physician. They will then be transported from the ED or other unit to the hyperbaric unit maintaining airborne precautions based on the most current hospital protocol. All study personnel will have proper PPE at all times. The patient will then be placed into the monoplace chamber and when the chamber door is closed the patient will remove any respiratory filter/mask that was placed. The patient will receive 90 minutes of hyperbaric oxygen at 2.0 ATA with or without airbreaks per the hyperbaric physician. Upon completion of the treatment the patient will then return to the medical unit and continue all standard of care. Additional treatments (up to 5) can be given if warranted and agreed upon by the patient and all members of the team caring for the patient. After the intervention portion of this study, a chart review will be performed to compare the outcomes of intervention patients versus patients who received standard of care.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
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

  • •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • •Male or female, age > 18 years
  • •Positive COVID 19 test
  • •Respiratory compromise defined by SpO2 <93%
  • •Ability to sign informed consent

排除标准

  • •An individual who meets any of the following criteria will be excluded from participation in this study:
  • •Untreated Pneumothorax

研究组 & 干预措施

Hyperbaric oxygen therapy (HBOT)

Experimental

干预措施: hyperbaric oxygen therapy (HBOT) (Device)

Standard of Care

No Intervention

结局指标

主要结局

Mortality

时间窗: through study completion; an average of 50 days

次要结局

  • Need for Mechanical Ventilation(through study completion; an average of 50 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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