Official Title
Open Label Single-Center Study of Emergency Hyperbaric Oxygen for Respiratory Distress in Patients With COVID-19
Brief Summary

Hyperbaric oxygen therapy (HBOT) treatment will be provided to patients as an adjunct to standard therapy for a cohort of 40 COVID19-positive patients with respiratory distress at NYU Winthrop Hospital. All patients prior to the clinical application of HBOT will be evaluated by the primary care team and hyperbaric physician. After the intervention portion of this study, a chart review will be performed to compare the outcomes of intervention patients versus patients who received standard of care.

Detailed Description

This is a single center prospective pilot cohort study to evaluate the safety and efficacy of
hyperbaric oxygen therapy (HBOT) as an emergency investigational device for treating patients
with a novel coronavirus, disease, COVID-19. Patients that meet inclusion criteria will be
consented by the hyperbaric physician. They will then be transported from the ED or other
unit to the hyperbaric unit maintaining airborne precautions based on the most current
hospital protocol. All study personnel will have proper PPE at all times. The patient will
then be placed into the monoplace chamber and when the chamber door is closed the patient
will remove any respiratory filter/mask that was placed. The patient will receive 90 minutes
of hyperbaric oxygen at 2.0 ATA with or without airbreaks per the hyperbaric physician. Upon
completion of the treatment the patient will then return to the medical unit and continue all
standard of care. Additional treatments (up to 5) can be given if warranted and agreed upon
by the patient and all members of the team caring for the patient. After the intervention
portion of this study, a chart review will be performed to compare the outcomes of
intervention patients versus patients who received standard of care.

Terminated
COVID-19

Device: hyperbaric oxygen therapy (HBOT)

The patient will receive 90 minutes of hyperbaric oxygen at 2.0 ATA with or without airbreaks per the hyperbaric physician. Upon completion of the treatment the patient will then return to the medial unit and continue all standard of care. Additional treatments (up to 5) can be given if warranted and agreed upon by the patient and all members of the team caring for the patient.

Eligibility Criteria

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the
following criteria:

1. Male or female, age > 18 years

2. Positive COVID 19 test

3. Respiratory compromise defined by SpO2 <93%

4. Ability to sign informed consent

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation
in this study:

1. Pregnancy

2. Untreated Pneumothorax

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

NYU Winthrop Hospital
Mineola, New York, United States

NYU Langone Health
NCT Number
MeSH Terms
COVID-19