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

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StatusRekrutacyjny

Sponsorzy

Asociación Argentina de Medicina Hiperbárica e Investigación

Współpracownicy

Hospital de Infecciosas Francisco Javier Muniz

Hospital General de Agudos D. F. Santojanni

Hospital Central de San Isidro Dr. Melchor Angel Posse

BADANIE KLINICZNE: NCT04477954

BioSeek: nct04477954

Słowa kluczowe

Abstrakcyjny

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.

Daktyle

Ostatnia weryfikacja:	06/30/2020
Pierwsze przesłane:	07/15/2020
Szacowana liczba przesłanych rejestracji:	07/16/2020
Wysłany pierwszy:	07/19/2020
Ostatnia aktualizacja przesłana:	07/16/2020
Ostatnia opublikowana aktualizacja:	07/19/2020
Rzeczywista data rozpoczęcia badania:	07/05/2020
Szacowana data zakończenia podstawowej działalności:	10/31/2020
Szacowana data zakończenia badania:	12/29/2020

Stan lub choroba

Covid19

Interwencja / leczenie

Combination Product: Experimental HBOT

Faza

Faza 2

Grupy ramion

Ramię	Interwencja / leczenie
Experimental: Experimental HBOT 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.	Combination Product: Experimental HBOT Hyperbaric oxygen therapy (HBOT): inhalation of pressurized oxygen through a hyperbaric chamber (Revitalair430)
No Intervention: Standard care

Kryteria kwalifikacji

Wiek kwalifikujący się do nauki	18 Years Do 18 Years
Płeć kwalifikująca się do nauki	All
Przyjmuje zdrowych wolontariuszy	tak
Kryteria	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).

Wynik

Podstawowe miary wyników

1. 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.

Miary wyników wtórnych

1. Need for Invasive Mechanical Ventilation (IMV) and / or Respiratory Distress Syndrome Acute (ARDS) [30 days]

Number of patients who required IMV after being enrolled

2. 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.

3. 30-day mortality [30 days]

Number of patients who died in that period since enrollment

4. Hypotension with vasopressor requirement [30 days]

Number of patients with hypotension who were administered vasopressors in this period

5. Mortality [45 days / 60 days / 90 days and 180 days]

Number of patients who died in that period since enrollment.

Inne miary wyników

1. 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

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

Słowa kluczowe

covid-19

pneumonia

coronavirus infections

hypoxia

zapalenie

obrzęk

niewydolność oddechowa

przeciwutleniacz