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| Name | Class |
|---|---|
| Dartmouth College | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperbaric oxygen treated group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric oxygen treatment (HBOT) | Device | Hyperbaric oxygen refers to oxygen given at pressures higher than atmospheric pressure (higher than 1.4 ATA) in pressurized chamber. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life EuroQOL EQ-5D-5L Questionnaire | 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. | Within one week of starting HBO2 and within one week of ending HBO2 treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Urogenital Distress Inventory | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samantha Leigh | Contact | 540-819-5715 | samantha.m.leigh@dartmouth.edu | |
| Jay Buckey | Contact | Jay.C.Buckey.Jr@dartmouth.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jay Buckey | Dartmouth-Hichcock Medical Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39078624 | Background | 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. | |
| 36001560 | Background |
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|
| 100% Oxygen | Drug | Receiving 100% oxygen as part of HBOT |
|
|
| Within one week of starting HBO2 treatments and within one week completing HBO2 treatments |
| Bowel symptoms questionnaire | 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. | Within one week of starting HBO2 treatments and within one week completing HBO2 treatments |
| Head and Neck Questionnaire | 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. | Within one week of starting HBO2 treatments and within one week completing HBO2 treatments |
| Perianal Crohn's Symptom Index Questionnaire | 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. | Within one week of starting HBO2 treatments and within one week completing HBO2 treatments |
| Hip dysfunction and Osteoarthritis Outcome Score (HOOS) Questionnaire | 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. | Within one week of starting HBO2 treatments and within one week completing HBO2 treatments |
| Wound Score (Strauss Score) | 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. | Within one week of starting HBO2 treatments and within one week completing HBO2 treatments |
| Subjective Assessment | 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. | Within one week of starting HBO2 treatments and within one week completing HBO2 treatments |
| Calciphylaxis Measurement Package | 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 interventions | Within one week of starting HBO2 treatments and within one week completing HBO2 treatments |
| Frostbite Measurement Package | For all individuals treated for frostbite data will be collected on: Number of wounds Wound measurements in cm Number of surgical interventions | Within one week of starting HBO2 treatments and within one week completing HBO2 treatments |
| Pyoderma Gangrenosum Measurement Package | For all individuals treated for pyoderma gangrenous data will be collected on: Number of wounds Wound measurements in cm Number of surgical interventions | Within one week of starting HBO2 treatments and within one week completing HBO2 treatments |
| Raynaud Syndrome Measurement Package | For all individuals treated for Raynaud's data will be collected on: Number of wounds Wound measurements in cm Number of surgical interventions | Within one week of starting HBO2 treatments and within one week completing HBO2 treatments |
| 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. |
| 32579537 | Background | 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. |
| Background | 1. Huang ET. Hyperbaric Medicine Indications Manual. 15th ed. North Palm Beach, FL: Best Publishing Company; 2023 2023. 445 p. |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| D002115 | Calciphylaxis |
| D005627 | Frostbite |
| D017511 | Pyoderma Gangrenosum |
| D011625 | Pterygium |
| D007021 | Hypospadias |
| D006259 | Craniocerebral Trauma |
| D011928 | Raynaud Disease |
| D018917 | Optic Neuropathy, Ischemic |
| D012170 | Retinal Vein Occlusion |
| D000072742 | Invasive Fungal Infections |
| D006086 | Graft vs Host Disease |
| D003668 | Pressure Ulcer |
| D012006 | Rectovaginal Fistula |
| D019449 | Pouchitis |
| D014012 | Tinnitus |
| D004761 | Enterocolitis, Pseudomembranous |
| D015356 | Retinal Artery Occlusion |
| D020196 | Trauma, Nervous System |
| D009103 | Multiple Sclerosis |
| D018979 | Myositis, Inclusion Body |
| D004820 | Epidermolysis Bullosa |
| D010020 | Osteonecrosis |
| D016459 | Prosthesis-Related Infections |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D002114 | Calcinosis |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000067390 | Cold Injury |
| D014947 | Wounds and Injuries |
| D011711 | Pyoderma |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017445 | Skin Diseases, Vascular |
| D012883 | Skin Ulcer |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009422 | Nervous System Diseases |
| D000090122 | Livedoid Vasculopathy |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D012164 | Retinal Diseases |
| D020246 | Venous Thrombosis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D007154 | Immune System Diseases |
| D012003 | Rectal Fistula |
| D007412 | Intestinal Fistula |
| D016154 | Digestive System Fistula |
| D012002 | Rectal Diseases |
| D014624 | Vaginal Fistula |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007079 | Ileitis |
| D004751 | Enteritis |
| D007077 | Ileal Diseases |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D004760 | Enterocolitis |
| D001157 | Arterial Occlusive Diseases |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D009220 | Myositis |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D012868 | Skin Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D012872 | Skin Diseases, Vesiculobullous |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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