Hyperbaric Oxygen for COVID-19 Patients

NYU Langone Health

Status: Terminated

Conditions: COVID-19

Treatments: Device: hyperbaric oxygen therapy (HBOT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04332081

20-00399

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

Hyperbaric oxygen therapy (HBOT)

Experimental group

Treatment:

Device: hyperbaric oxygen therapy (HBOT)

Standard of Care

No Intervention group