Multicentre Randomized Controlled Trial of Hyperbaric Versus Normobaric Oxygen Therapy for COVID-19 Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 234
- 试验地点
- 2
- 主要终点
- 7-level COVID Ordinal Outcome Scale
研究概览
简要总结
At least 1 in 6 COVID-19 patients admitted to hospital to receive extra oxygen will die of complications. In patients with COVID-19, invasive treatment such as mechanical ventilation (e.g. breathing with a machine) is associated with a 50% increased risk of death. Invasive treatments use a lot of healthcare resources in intensive care units and may lead to further deaths if patients do not have access to care.
The investigators aim to improve outcomes for COVID-19 patients by implementing hyperbaric oxygen therapy (HBOT). HBOT allows patients to breathe 100% oxygen in a special chamber at a pressure higher than sea level. It is approved by Health Canada for 14 conditions. HBOT is safe when administered by experienced teams.
There are two main causes of death in severe COVID-19 respiratory infections: (i) a decreased diffusion of oxygen from the lungs to the blood and (ii) an increased inflammatory response (also called a "cytokine storm"). HBOT leads to increased oxygen level in blood, has strong anti-inflammatory effects, and may destroy the virus responsible for COVID-19 disease. The initial experience with HBOT and COVID-19 from China, France and the United States is promising in that it prevents further worsening of the condition and need for intensive care.
The investigators propose to test the effectiveness of HBOT for COVID-19 patients who are admitted to hospital to receive extra oxygen. Using the most rigorous and innovative research methods, this Canadian-led international study will operate at 5 centers across 3 countries (Canada: Ottawa, Toronto, Edmonton; Switzerland: Geneva; UK: Rugby/London). The investigators anticipate that when treated by HBOT, COVID-19 patients needing extra oxygen to breathe will see significant health improvements as well as a decrease in complications, inflammation in the blood, need for invasive care, death, and cost of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Male or non-pregnant female patients
- •Age ≥18 years
- •Confirmed COVID-19 positive by RT-PCR or another validated method
- •Diagnosed with pneumonia requiring 21%<FIO2≤100% to maintain saturation by pulse oximetry (SpO2) ≥90%
- •Able and willing to comply with study procedures and follow-up examinations contained within the written consent form
排除标准
- •Patient clinical status felt to be incompatible with HBOT, e.g. respiratory failure requiring mechanical ventilation
- •Pregnancy, determined by a serum or urine test
- •Hemodynamic instability requiring vasopressors
- •Inability to maintain a sitting position during treatment
- •Inability to effectively understand and communicate with the hyperbaric operator, or to give consent
- •Inability to spontaneously equalize ears and refusal of myringotomies
- •Contraindications to HBOT (e.g. pneumothorax)
研究组 & 干预措施
HBOT
These patients will receive hyperbaric oxygen therapy (HBOT) in addition to usual treatment for COVID-19. HBOT sessions will be 75 minutes in length at a pressure of 2.0 ATA.
干预措施: Oxygen (Drug)
结局指标
主要结局
7-level COVID Ordinal Outcome Scale
时间窗: Measured on Day 7
7-level scale based on patient's current status and need for oxygenation, also ability to resume normal activities (at higher levels). Range is 1-7. Higher number indicates better clinical outcome.
次要结局
- Length of hospital stay(Duration of study (to Day 28))
- Sleep quality(Duration of study (to Day 28))
- Daily oxygen flow values required to obtain saturation values ≥90%,(Duration of study (to Day 28))
- Major arterial and venous thrombotic events(Duration of study (to Day 28))
- Mortality(Duration of study (to Day 28))
- Incidence of any adverse events related to HBOT(Duration of study (to Day 28))
- Days on invasive mechanical ventilation or high flow oxygenation(Duration of study (to Day 28))
- Days with oxygen supplementation(Duration of study (to Day 28))
- ICU admission(Duration of study (to Day 28))
- ICU length of stay(Duration of study (to Day 28))
- Fatigue(Duration of study (to Day 28))
- 7-level COVID Ordinal Outcome Scale(Measured on Day 28)