Emerging Indications for Hyperbaric Oxygen Treatment
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Quality of Life EuroQOL EQ-5D-5L Questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred for HBOT with an emerging indication
排除标准
- •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
研究组 & 干预措施
Hyperbaric oxygen treated group
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.
干预措施: 100% Oxygen (Drug)
Hyperbaric oxygen treated group
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.
干预措施: Hyperbaric oxygen treatment (HBOT) (Device)
结局指标
主要结局
Quality of Life EuroQOL EQ-5D-5L Questionnaire
时间窗: 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.
次要结局
- Hip dysfunction and Osteoarthritis Outcome Score (HOOS) Questionnaire(Within one week of starting HBO2 treatments and within one week completing HBO2 treatments)
- Wound Score (Strauss Score)(Within one week of starting HBO2 treatments and within one week completing HBO2 treatments)
- Pyoderma Gangrenosum Measurement Package(Within one week of starting HBO2 treatments and within one week completing HBO2 treatments)
- Raynaud Syndrome Measurement Package(Within one week of starting HBO2 treatments and within one week completing HBO2 treatments)
- Urogenital Distress Inventory(Within one week of starting HBO2 treatments and within one week completing HBO2 treatments)
- Bowel symptoms questionnaire(Within one week of starting HBO2 treatments and within one week completing HBO2 treatments)
- Head and Neck Questionnaire(Within one week of starting HBO2 treatments and within one week completing HBO2 treatments)
- Perianal Crohn's Symptom Index Questionnaire(Within one week of starting HBO2 treatments and within one week completing HBO2 treatments)
- Subjective Assessment(Within one week of starting HBO2 treatments and within one week completing HBO2 treatments)
- Calciphylaxis Measurement Package(Within one week of starting HBO2 treatments and within one week completing HBO2 treatments)
- Frostbite Measurement Package(Within one week of starting HBO2 treatments and within one week completing HBO2 treatments)
研究者
Jay C. Buckey Jr.
Principal Investigator
Dartmouth-Hitchcock Medical Center
