Outcomes From Hyperbaric Oxygen (HBO2) Treatment for Emerging Indications
- Conditions
- Post-COVID-19 ConditionUlcerative ColitisCrohn DiseaseCalciphylaxisFrostbiteAcute COVID-19Pyoderma GangrenosumPterygiumHypospadiasHead Trauma
- Interventions
- Device: Hyperbaric oxygen treatment (HBOT)
- Registration Number
- NCT07240649
- Lead Sponsor
- Jay C. Buckey Jr.
- Brief Summary
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 (Huang, 2023). 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 (Harlan 2020, Harlan 2022).
In a recent publication from our group, we presented data for 45 emerging indications for hyperbaric oxygen treatment (Tanaka 2024). 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Patients referred for HBOT with an emerging indication
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hyperbaric oxygen treated group Hyperbaric oxygen treatment (HBOT) 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. Hyperbaric oxygen treated group 100% Oxygen 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.
- Primary Outcome Measures
Name Time Method Quality of Life EuroQOL EQ-5D-5L Questionnaire Within one week of starting HBO2 and within one week of ending HBO2 treatment Every individual has quality of life measured using the EuroQol EQ-5D-5L measure. The measure has 5 scales (Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression), that each have 5 levels (none, slight, moderate, severe, unable). The scores are calculated using the procedures outlined in the EuroQOL handbook to create a final score on a 0-1 scale. There is also an overall visual analog scale that asks about perceived health on a 0-100 scale. Higher scores indicate better quality of life. Data are aggregated in the Multicenter Registry for Hyperbaric Oxygen Treatment.
- Secondary Outcome Measures
Name Time Method Hip dysfunction and Osteoarthritis Outcome Score (HOOS) Questionnaire Within one week of starting HBO2 treatments and within one week completing HBO2 treatments Individuals with conditions involving the knee or hip will complete the HOOS questionnaire. The questions are divided into symptoms, stiffness, pain, function (daily living), function (sports), and quality of life. Symptoms are measured on a 5 point scale from none to extreme. The answers are computed into individual sub scales for each major area and an overall total score. Higher numbers indicate more symptoms.
Wound Score (Strauss Score) Within one week of starting HBO2 treatments and within one week completing HBO2 treatments Individuals with wounds will have the wound (Strauss) score completed. The score covers five areas (Appearance, Size, Depth, Infection/Bioburden, and Perfusion). Each area is graded from best (2 points) to worst (0 points). Depth also has a possible 1.5 score for subcutaneous tissue involvement. Higher scores are better with healthy wounds in the 7.5 to 10 point range.
Pyoderma Gangrenosum Measurement Package Within one week of starting HBO2 treatments and within one week completing HBO2 treatments For all individuals treated for pyoderma gangrenous data will be collected on:
Number of wounds Wound measurements in cm Number of surgical interventionsRaynaud Syndrome Measurement Package Within one week of starting HBO2 treatments and within one week completing HBO2 treatments For all individuals treated for Raynaud's data will be collected on:
Number of wounds Wound measurements in cm Number of surgical interventionsUrogenital Distress Inventory Within one week of starting HBO2 treatments and within one week completing HBO2 treatments Patients with cystitis will complete the Urinogential Distress Inventory (UDI). The six questions ask about symptoms on a 4 point scale (No= 0, Not at all= 1, Somewhat= 2, Moderately= 3, Quite a bit= 4). The UDI scaled score is calculated by adding all scores and multiplying by 6 and then multiply by 25 for the scale score. Missing items are dealt with by using the mean from the answered items only. Higher score = higher disability.
Bowel symptoms questionnaire Within one week of starting HBO2 treatments and within one week completing HBO2 treatments Those with conditions affecting the gastrointestinal tract will complete the bowel symptoms questionnaire. The questionnaire has nine questions that cover the areas of frequency, blood, pain, and urgency. Severity is rated on a 4 point scale from 0 to 4 with 4 being severe. Higher values indicate more symptoms.
Head and Neck Questionnaire Within one week of starting HBO2 treatments and within one week completing HBO2 treatments The head and neck questionnaire has 37 questions selected from the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-H\&N35 and the Groningen Radiotherapy-Induced Xerostomia (GRIX) questionnaire. The questionnaire covers dry mouth, pain, and difficulties with smell and taste. The scores are converted to a 0-100 scale with higher numbers indicating more symptoms.
Perianal Crohn's Symptom Index Questionnaire Within one week of starting HBO2 treatments and within one week completing HBO2 treatments The perianal Crohn's symptom index has 13 questions that cover fistulas, fistula discharge, rectal discharge, bowel frequency, urgency, blood, and pain. The answers are converted to an overall summed score with higher levels indicating more symptoms.
Subjective Assessment Within one week of starting HBO2 treatments and within one week completing HBO2 treatments For all enrollees a 4 level subjective assessment will be completed. The scale ranges from 1 resolved/healed to 4 worse with higher levels indicating less improvement.
Calciphylaxis Measurement Package Within one week of starting HBO2 treatments and within one week completing HBO2 treatments For individuals treated for calciphylaxis, data will be collected on the following parameters:
Number of wounds Pre and post wound measurements in cm Number of surgical interventionsFrostbite Measurement Package Within one week of starting HBO2 treatments and within one week completing HBO2 treatments For all individuals treated for frostbite data will be collected on:
Number of wounds Wound measurements in cm Number of surgical interventions