Effect of Hyperbaric Oxygen Therapy (OHB) in patients hospitalized by COVID-19

Phase 3

Recruiting

• Conditions: Coronavirus infections of unspecified location; Severe acute respiratory syndrome; A00-B99; J00-J99

• Registration Number: RBR-92vxxk6
• Lead Sponsor: Hospital Risoleta Tolentino Neves

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-16
• Study Completion: 2022-05-31
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients over 18 years of age; diagnosis confirmed by laboratory tests or computed tomography (CT) of the chest compatible with COVID-19; oxygen saturation below 93% in ambient air; respiratory frequency greater than or equal to 24 resp / min; without a significant commitment from other bodies or systems.

Exclusion Criteria

Hemodynamic instability, defined by mean arterial pressure less than 60 mmHg; respiratory failure requiring intubation; blood levels of TGO/TGP greater than 5 times the upper limit of normal; several chronic kidney diseases in stage 4; kidney disease requiring dialysis, that is, with eGFR (Estimated Glomerular Filtration Rate) less than 30 mL/min; transition planned to another hospital, other than a place of study, within 72 hours; infection with the human immunodeficiency virus under highly active antiretroviral therapy (HAART); history of severe depression or attempted suicide or current suicidal ideation; contraindications related to the administration of hyperbaric oxygen: pregnancy; breast-feeding; untreated pneumothorax; use of adriblastine, cisplatin, doxorubicin and mafenide; topical use of iodine and / or petrolatum; advanced emphysema with CO2 retention; claustrophobia; other conditions identified by the hyperbarist team.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the inpatient time; need for mechanical ventilation (intubation); mortality and incidence of serious adverse events.

Secondary Outcome Measures

Name	Time	Method
Evaluate oximetry at admission and during hospitalization; time on days of supplemental oxygen use; number of days free from the need for supplemental oxygenation; time on days of non-invasive ventilation (NIV) use; time in days of use of invasive ventilation (orotracheal intubation); laboratory tests at admission and during hospitalization: hemoglobin, platelets, creatinine, leukocytes, electrolytes, prothrombin, glucose, bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and albumin.