Status:
TERMINATED
Hyperbaric Oxygen as an Adjuvant Treatment for Patients With Covid-19 Severe Hypoxemia
Lead Sponsor:
Asociación Argentina de Medicina Hiperbárica e Investigación
Collaborating Sponsors:
Hospital de Infecciosas Francisco Javier Muniz
Hospital General de Agudos D. F. Santojanni
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04477954
Start Date
July 6 2020
End Date
December 30 2020
Last Update
January 15 2021
Active Locations (3)
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1
Hospital Central de San Isidro Dr. Angel Melchor Posse
San Isidro, Buenos Aires, Argentina, 1641
2
Hospital de Infecciosas F. J. Muñiz
Buenos Aires, Buenos Aires F.D., Argentina, 1282
3
Hospital General de Agudos D.F Santojanni
Buenos Aires, Buenos Aires F.D., Argentina, 1408