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| Name | Class |
|---|---|
| Climate Foundation | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HBOT | Experimental | 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. |
|
| Control | No Intervention | These patients will receive usual treatment for COVID-19, including oxygenation at normal atmospheric pressure (normobaric oxygenation). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen | Drug | Hyperbaric oxygen therapy delivered in a monoplace or multi-place chamber. Supervised by a hyperbaric oxygen therapy physician and a chamber operator. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 7-level COVID Ordinal Outcome Scale | 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. | Measured on Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | Measured in days | Duration of study (to Day 28) |
| Days with oxygen supplementation | Number of days with oxygen supplementation |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sylvain Boet, MD, PhD | Contact | 613-737-8899 | 78187 | sboet@toh.ca |
| Joseph Burns, MSc | Contact | 613-798-5555 | 14775 | josburns@ohri.ca |
| Name | Affiliation | Role |
|---|---|---|
| Sylvain Boet, MD, PhD | The Ottawa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital | Not yet recruiting | Ottawa | Ontario | K1Y4E9 | Canada |
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| Label | URL |
|---|---|
| Preprint of study protocol (brief version for publication) | View source |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| Duration of study (to Day 28) |
| Daily oxygen flow values required to obtain saturation values ≥90%, | Measured in L/min | Duration of study (to Day 28) |
| ICU admission | Yes/No | Duration of study (to Day 28) |
| ICU length of stay | Measured in days, if applicable | Duration of study (to Day 28) |
| Days on invasive mechanical ventilation or high flow oxygenation | Number of days on ventilator | Duration of study (to Day 28) |
| Major arterial and venous thrombotic events | e.g. stroke, pulmonary embolism, deep vein thrombosis | Duration of study (to Day 28) |
| Sleep quality | 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 | Duration of study (to Day 28) |
| Fatigue | 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. | Duration of study (to Day 28) |
| 7-level COVID Ordinal Outcome Scale | Same scale as the primary outcome; different timing as a secondary outcome. Range is 1-7. Higher number indicates better clinical outcome. | Measured on Day 28 |
| Mortality | Number of deaths | Duration of study (to Day 28) |
| Incidence of any adverse events related to HBOT | Number of adverse events | Duration of study (to Day 28) |
| Rouge Valley Hyperbaric Medical Centre | Recruiting | Scarborough Village | Ontario | M1E 5E9 | Canada |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |