Covid19
Conditions
Keywords
Hyperbaric oxygen therapy
Brief summary
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.
Interventions
DRUGOxygen
Hyperbaric oxygen therapy delivered in a monoplace or multi-place chamber. Supervised by a hyperbaric oxygen therapy physician and a chamber operator.
Sponsors
Climate Foundation
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-level COVID Ordinal Outcome Scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days with oxygen supplementation | Duration of study (to Day 28) | Number of days with oxygen supplementation |
| Daily oxygen flow values required to obtain saturation values ≥90%, | Duration of study (to Day 28) | Measured in L/min |
| ICU admission | Duration of study (to Day 28) | Yes/No |
| ICU length of stay | Duration of study (to Day 28) | Measured in days, if applicable |
| Days on invasive mechanical ventilation or high flow oxygenation | Duration of study (to Day 28) | Number of days on ventilator |
| Length of hospital stay | Duration of study (to Day 28) | Measured in days |
| Sleep quality | Duration of study (to Day 28) | Sleep Quality Scale, measured from 0 to 10. Higher number indicates worse sleep quality: 0 = best possible sleep, 10 = worst possible sleep. Capelleri et. al; Health and Quality of Life Outcomes 2009: 7:54 |
| Fatigue | Duration of study (to Day 28) | Single-Item Fatigue Report Mark, measured from 1 to 10. Higher number indicates worse fatigue: 1 = not at all, 10 = extremely. van Hooff et al; J Occup Health 2007; 49:224-234. |
| 7-level COVID Ordinal Outcome Scale | Measured on Day 28 | Same scale as the primary outcome; different timing as a secondary outcome. Range is 1-7. Higher number indicates better clinical outcome. |
| Mortality | Duration of study (to Day 28) | Number of deaths |
| Incidence of any adverse events related to HBOT | Duration of study (to Day 28) | Number of adverse events |
| Major arterial and venous thrombotic events | Duration of study (to Day 28) | e.g. stroke, pulmonary embolism, deep vein thrombosis |
Countries
Canada
Contacts
Primary ContactSylvain Boet, MD, PhD
Backup ContactJoseph Burns, MSc
Outcome results
None listed