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
- 1
- 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
研究组 & 干预措施
Control Group
Historical control of COVID 19 patients who were previously treated and did not receiving Hyperbaric Oxygen Therapy
Study Group
Identified COVID 19 patients receiving the intervention of Hyperbaric Oxygen Therapy
干预措施: Hyperbaric Oxygen Therapy (Other)
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)