Emerging Indications for Hyperbaric Oxygen Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hyperbaric oxygen treatment (HBOT), 100% Oxygen.
- Who it may be relevant to
- Registry conditions: Post-COVID-19 Condition, Ulcerative Colitis, Crohn Disease, Calciphylaxis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed 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.
Interventions
- Device Hyperbaric oxygen treatment (HBOT)
Hyperbaric oxygen refers to oxygen given at pressures higher than atmospheric pressure (higher than 1.4 ATA) in pressurized chamber. - Drug 100% Oxygen
Receiving 100% oxygen as part of HBOT
Primary outcome measures
- Quality of Life EuroQOL EQ-5D-5L Questionnaire [Time frame: Within one week of starting HBO2 and within one week of ending HBO2 treatment]
Secondary outcome measures (11)
- Urogenital Distress Inventory [Time frame: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments]
- Bowel symptoms questionnaire [Time frame: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments]
- Head and Neck Questionnaire [Time frame: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments]
- Perianal Crohn's Symptom Index Questionnaire [Time frame: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments]
- Hip dysfunction and Osteoarthritis Outcome Score (HOOS) Questionnaire [Time frame: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments]
- Wound Score (Strauss Score) [Time frame: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments]
- Subjective Assessment [Time frame: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments]
- Calciphylaxis Measurement Package [Time frame: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments]
- Frostbite Measurement Package [Time frame: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments]
- Pyoderma Gangrenosum Measurement Package [Time frame: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments]
- Raynaud Syndrome Measurement Package [Time frame: Within one week of starting HBO2 treatments and within one week completing HBO2 treatments]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Tanaka HL, Rees JR, Zhang Z, Ptak JA, Hannigan PM, Silverman EM, Peacock JL, Buckey JC; Multicenter Registry for Hyperbaric Oxygen Treatment Consortium. Emerging Indications for Hyperbaric Oxygen Treatment: Registry Cohort Study. Interact J Med Res. 2024 Aug 20;13:e53821. doi: 10.2196/53821. PMID 39078624
- Harlan NP, Ptak JA, Rees JR, Cowan DR, Fellows AM, Moses RA, Kertis JA, Hannigan PM, Juggan SA, Peacock J, Bennett M, Buckey JC. International Multicenter Registry for Hyperbaric Oxygen Therapy: Results through June 2021. Undersea Hyperb Med. 2022 Third Quarter;49(3):275-287. PMID 36001560
- Harlan NP, Ptak JA, Rees JR, Cowan DR, Fellows AM, Kertis JA, Hannigan PM, Peacock JL, Buckey JC. Development of an International, Multicenter, Hyperbaric Oxygen Treatment Registry and Research Consortium: Protocol for Outcome Data Collection and Analysis. JMIR Res Protoc. 2020 Aug 17;9(8):e18857. doi: 10.2196/18857. PMID 32579537
- 1. Huang ET. Hyperbaric Medicine Indications Manual. 15th ed. North Palm Beach, FL: Best Publishing Company; 2023 2023. 445 p.
Identifiers
NCT: NCT07240649 · STUDY02003096