The Use of Hyperbaric Oxygen Therapy (HBOT) for the Treatment of COVID-19 Patients With Mild-to-moderate Respiratory Distress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Normalization of oxygen
研究概览
简要总结
Investigate whether hyperbaric oxygen therapy treatment can become a viable treatment option for COVID-19. If successful, providers will be able to provide future COVID-19 patients with mild-to-moderate respiratory distress hyperbaric oxygen therapy in order to help avoid mechanical ventilation
详细描述
Using the Monoplace Hyperbaric Oxygen Chambers we will be providing COVID- 19 positive patients with mild-to-moderate distress 100% oxygen at 2.0 ATA for 90 minutes on consecutive days for a total of up to 5 treatments. A comparison will be made using a historical cohort not receiving HBOT. Data will be collected to determine whether or not HBOT is of any benefit to COVID-19 positive patient with mild-to-moderate respiratory distress.
Study Group: Provide 100% oxygen at 2.0 ATA for 90 minutes on consecutive days for a total of up to 5 treatment to COVID-19 patients meeting inclusion criteria Control Group: Any COVID-19 positive patient meeting study inclusion criteria that does not receive HBOT (historical) The control group is further defined as patients who were previously treated for COVID-19 at Morton Hospital that did not receive hyperbaric oxygen therapy. This will require accessing medical records to obtain patient information to establish the historical control data metric.
Study outcome measures:
- Time to normalize 02 requirement (ambient air pulse ox greater than or equal to 92% or ABG w/Pa02 greater than 60mmHG on air)
- Mortality
- Days free of invasive mechanical ventilation
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
- •Verified COVID-19 infection
- •Patient w/02 dependence of less than or equal to 6 liter/min to maintain pulse ox greater than or equal to 92% or arterial gas w/PA02 greater than 60mm HG
排除标准
- •Not diagnosed w/COVID-19 infection
- •Pregnancy
- •DNR or other restrictions in escalation of level of care
- •Contraindication for HBO
- •Blood pressure parameters which are deemed unstable by clinical team
- •Patients who require continuous ECG and/or continuous blood pressure monitoring, and with arterial lines
- •Patients requiring rewarming
- •Patients requiring any kind of invasive catheter/pressure monitoring
- •Patients requiring continuous support of intravenous medication
- •Minor subject (less than 18 years old)
- •Refusal to participate
- •Signs of respiratory decompensation requiring intubation and mechanical ventilation
- •02 dependence greater than or equal to 6L/minute to obtain Sa02 greater than or equal to 92% or ABG w/Pa02 >60mmHg
结局指标
主要结局
Normalization of oxygen
时间窗: through study completion, an average of 1 year
normalize 02 requirement (ambient air pulse ox greater than or equal to 92% or ABG w/Pa02 greater than 60mmHG on air)
次要结局
- Days free of invasive mechanical ventilation(through study completion, an average of 1 year)
- Mortality(through study completion, an average of 1 year)