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

Randomized controlled clinical trial on the effect of Hyperbaric Oxygen Therapy (HBO) in non intubated COVID-19 hospitalized patients

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-92vxxk6
Enrollment
Unknown
Registered
2021-08-16
Start date
2021-05-24
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus infections of unspecified location

Interventions

Patients will be randomized into two groups in a 1:1 ratio through a four-patient block randomization program. Intervention group: 24 patients (both gender and aged 18 years or above) diagnosed with C

Sponsors

Hospital Risoleta Tolentino Neves
Lead Sponsor
Ecotec Equipamentos e Sistemas Eirelli
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
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.

Countries

Brazil

Contacts

Public ContactRogério;Túlio Noronha;Navarro

Hospital Risoleta Tolentino Neves;

rogerio_noronha@yahoo.com.br;tulio.navarro@gmail.com+5531993849007;+5531996131050

Outcome results

None listed

Source: REBEC (via WHO ICTRP)