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Investigators and Ethic Committee endorsed early suspension of the protocol because of superiority and safety. For the interim analysys, the statistical methodology presented by Pocock was followed.
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| Name | Class |
|---|---|
| Hospital de Infecciosas Francisco Javier Muniz | OTHER_GOV |
| Hospital General de Agudos D. F. Santojanni | UNKNOWN |
| Hospital Central de San Isidro Dr. Melchor Angel Posse | UNKNOWN |
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The severity of COVID-19 is related to the level of hypoxemia, respiratory failure, how long it lasts and how refractory it is at increasing concentrations of inspired oxygen. The inability to perform hematosis due to edema that occurs from acute inflammation could be attenuated by the administration of hyperbaric oxygen (HBO). Recently, it has been reported benefits in this matter in patients with SARS-CoV-2 hypoxemic pneumonia in China; where the administration of repeated HBO sessions decreased the need for mechanical ventilation (MV) in patients admitted to the Intensive Care Unit due to COVID-19. Hyperbaric oxygen is capable of increasing drastically the amount of dissolved oxygen in the blood and maintain an adequate supply oxygen to the tissues. In addition to this, it can influence immune processes, both humoral and cellular, allowing to reduce the intensity of the response inflammatory and stimulate antioxidant defenses. HBO is considered safe and it has very few adverse events, it is a procedure approved by our authorities regulatory for several years. In the current context of the pandemic by COVID-19 and worldwide reports of mortality associated with severe cases of respiratory failure, it is essential to propose therapeutical strategies to limit or decrease respiratory compromise of severe stages by COVID-19. That is why, it is proposed to carry out this research to assess whether HBO treatment can improve the evolution of patients with COVID-19 severe hypoxemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental HBOT | Experimental | Treatment (device). Patients will receive 90 minutes of hyperbaric oxygen at 1,45 ATA in a Revitalair430 hyperbaric chamber, and then they will continue with standard care and normobaric oxygen. |
|
| Standard care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric Oxygen | Combination Product | Hyperbaric oxygen therapy (HBOT): inhalation of pressurized oxygen through a hyperbaric chamber (Revitalair430) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to normalize the oxygen requirement (oxygen dependence) | Time to normalize the oxygen requirement: Allowing a pulse oximetry value in ambient air greater than or equal 93% and/or arterial blood gas with PaO2 value greater than 60 mmHg in ambient air. | 15-30 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Need for Invasive Mechanical Ventilation (IMV) and / or Respiratory Distress Syndrome Acute (ARDS) | Number of patients who required IMV after being enrolled | 30 days |
| Development of Acute Respiratory Distress Syndrome (ARDS) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Number of adverse events reported related to the device (Revitalair 430 hyperbaric chamber): otalgias, ear obstruction, barotrauma, significant and constant changes in blood pressure, heart rate and others | 4 hours finished session |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariana Cannellotto, MD | Asociación Argentina de Medicina Hiperbárica e Investigación | Study Chair |
| Mariano Duarte, PhD | Asociación Argentina de Medicina Hiperbárica e Investigación | Principal Investigator |
| Liliana Jorda-Vargas | Asociación Argentina de Medicina Hiperbárica e Investigación | Principal Investigator |
| Fabrizio Verdini, MD | Asociación Argentina de Medicina Hiperbárica e Investigación | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Central de San Isidro Dr. Angel Melchor Posse | San Isidro | Buenos Aires | 1641 | Argentina | ||
| Hospital de Infecciosas F. J. Muñiz |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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Parallel Assignment
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|
Number of patients who required IMV and / or had a diagnosis of ARDS after being enrolled.
| 30 days |
| 30-day mortality | Number of patients who died in that period since enrollment | 30 days |
| Hypotension with vasopressor requirement | Number of patients with hypotension who were administered vasopressors in this period | 30 days |
| Mortality | Number of patients who died in that period since enrollment. | 45 days / 60 days / 90 days and 180 days |
| Buenos Aires |
| Buenos Aires F.D. |
| 1282 |
| Argentina |
| Hospital General de Agudos D.F Santojanni | Buenos Aires | Buenos Aires F.D. | 1408 | Argentina |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |