Covid19
Conditions
Keywords
Hyperbaric Oxygen, Covid-19, Hypoxemia, Sars-CoV2, Hyperbaric Chamber
Brief summary
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.
Interventions
COMBINATION_PRODUCTHyperbaric Oxygen
Hyperbaric oxygen therapy (HBOT): inhalation of pressurized oxygen through a hyperbaric chamber (Revitalair430)
Sponsors
Hospital de Infecciosas Francisco Javier Muniz
Hospital General de Agudos D. F. Santojanni
Hospital Central de San Isidro Dr. Melchor Angel Posse
Asociación Argentina de Medicina Hiperbárica e Investigación
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years, all sexes. * No previous hospitalizations in the last 6 months. * Positive diagnostic test for COVID-19 according to the guidelines of the Argetine Ministry of Health at the time of enrollment. * Patient in Intensive Care Unit with oxygen need: Need for continuous supply of oxygen to maintain saturation by oximetry pulse (SpO2) greater than or equal to 93% or arterial gas with PaO2 value greater than 60 mmHg
Exclusion criteria
* 18 years of age. * Person unable to give consent. * Person who refuses to participate. * Pregnancy and lactation * Participating in other study * Requirement for mechanical ventilation. * Inability to maintain prolonged sitting position (at least 2 hours) * Subject with contraindications to HBOT (pulmonary shock, bullae, emphysema or untreated pneumothorax, severe seizures, uncontrolled hypertension, chronic obstructive disease of grade III or IV).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to normalize the oxygen requirement (oxygen dependence) | 15-30 days. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for Invasive Mechanical Ventilation (IMV) and / or Respiratory Distress Syndrome Acute (ARDS) | 30 days | Number of patients who required IMV after being enrolled |
| 30-day mortality | 30 days | Number of patients who died in that period since enrollment |
| Hypotension with vasopressor requirement | 30 days | Number of patients with hypotension who were administered vasopressors in this period |
| Mortality | 45 days / 60 days / 90 days and 180 days | Number of patients who died in that period since enrollment. |
| Development of Acute Respiratory Distress Syndrome (ARDS) | 30 days | Number of patients who required IMV and / or had a diagnosis of ARDS after being enrolled. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 4 hours finished session | 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 |
Countries
Argentina
Outcome results
None listed