Official Title
Hyperbaric Oxygen as an Adjuvant Treatment for Patients With Covid-19 Severe Hypoxemia
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.

Terminated
COVID19

Combination Product: Hyperbaric Oxygen

Hyperbaric oxygen therapy (HBOT): inhalation of pressurized oxygen through a hyperbaric chamber (Revitalair430)
Other Name: HBOT

Eligibility Criteria

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).

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Argentina
Locations

Hospital Central de San Isidro Dr. Angel Melchor Posse
San Isidro, Buenos Aires, Argentina

Hospital de Infecciosas F. J. Muñiz
Ciudad Autonoma de Buenos AIres, Caba, Argentina

Hospital General de Agudos D.F Santojanni
Ciudad Autonoma de Buenos AIres, Caba, Argentina

Asociación Argentina de Medicina Hiperbárica e Investigación
NCT Number
Keywords
Hyperbaric oxygen
Covid-19
Hypoxemia
SARS-CoV2
Hyperbaric Chamber
MeSH Terms
COVID-19
Hypoxia