Outcomes From Hyperbaric Oxygen (HBO2) Treatment for Emerging Indications

Jay C. Buckey Jr.

Status and phase: Begins enrollment this month; Phase 4

Conditions: Femoral Head Necrosis; Head Trauma; Prosthesis Related Infections; Invasive Fungal Infection; Inclusion Body Myositis; Frostbite; Central Retinal Vein Occlusion; Tinnitus; Hypospadias; Decubitus Ulcer; Raynaud Syndrome; Axonotmesis; Cartilage Injury; Nonarteritic Anterior Ischemic Optic Neuropathy; Multiple Sclerosis; Branch Retinal Artery Occlusion; Pterygium; Osteonecrosis; Ligament Injury; Greater Trochanteric Pain Syndrome; Rectovaginal Fistula; Crohn Disease; Pyoderma Gangrenosum; Vasculitic Ulcer; Post-COVID-19 Condition; Anastomosis, Leaking; Ischemic Bowel; Graft-vs-Host Disease; Chronic Anal Fissure; Calciphylaxis; Cystitis Chronic; Acute COVID-19; Ulcer Ischemic; Epidermolysis Bullosa (EB); Pouchitis; Clostridium Enterocolitis; Malignant Otitis Externa; Pneumatosis Intestinalis; Ulcerative Colitis; Facial Filler Injections; Avascular Necrosis of Bone

Treatments: Device: Hyperbaric oxygen treatment (HBOT); Drug: 100% Oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT07240649

STUDY02003096

Details and patient eligibility

About

This study will evaluate the effectiveness of hyperbaric oxygen therapy (HBOT) on treating emerging indications (i.e., conditions that have shown to potentially benefit from HBOT) using the Multicenter Registry for Hyperbaric Oxygen Treatment. The study team aims to collect ongoing data on how well HBOT treats these emerging indications, and to add these data to the growing HBO Registry. The research team hypothesizes that HBOT will result in improvements of the condition of the various emerging indications.

Full description

Currently, the Undersea and Hyperbaric Medical Society (UHMS) has identified 15 conditions where HBO2 can be considered an approved treatment. These range from decompression illness, where the combination of increased pressure, relief of hypoxia, and reduced inflammation from HBO2 help combat the impaired circulation and endothelial damage caused by bubbles, to radiation injury, where the pulses of oxygen promote angiogenesis and wound healing. Because of HBO2's effects on hypoxia and inflammation, more medical diagnoses exist that can benefit from HBO2. HBO2 is typically given in long courses (20-40 treatments), however, and most centers see only a limited number of patients. Therefore, gathering outcome data on HBO2 treatment has been limited, and often, only case reports or small case series are available to support its use. In addition, practice patterns differ across centers, and some centers may use HBO2 successfully for an indication that other centers may not consider it for. To gather more data on HBO2 applications, outcome data from multiple centers need to be combined. The goal of the Multicenter Registry for Hyperbaric Oxygen Treatment is to collect and aggregate these data.

In a recent publication from our group, we presented data for 45 emerging indications for hyperbaric oxygen treatment. A unifying theme among many of these indications is that they involve hypoxia and/or inflammation as prime drivers of the pathology.

For many of the indications the use of HBOT is based on the underlying pathophysiology, where the presence of hypoxia and/or inflammation indicates that HBOT might be useful. The outcome data, however, are based on case reports or small case series. This project will collect consistently acquired outcome data for indications where HBOT is being used, but the underlying data supporting its use is limited.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients referred for HBOT with an emerging indication

Exclusion criteria

• Contraindication to hyperbaric oxygen treatment (untreated seizures, pneumothorax, significant pulmonary airspace pathology that might lead to pulmonary barotrauma, unmanageable confinement anxiety, chronic obstructive pulmonary disease with CO2 retention)
• Pregnant persons

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Hyperbaric oxygen treated group

Experimental group

Description:

This individuals will be receiving hyperbaric oxygen treatment for the condition listed in the conditions section. Patients come daily for the treatment and receive hyperbaric oxygen at 2.0-2.4 atmospheres absolute for 90 minutes at the treatment pressure.

Treatment:

Drug: 100% Oxygen

Device: Hyperbaric oxygen treatment (HBOT)