Hyperbaric Oxygen, Neutrophil-oxidative Burst, and Cytokines: a Pilot Study
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Oxidative Burst Assay
研究概览
简要总结
In this small pilot study, participants (patients and healthy volunteers) will have blood drawn before and after the study intervention (hyperbaric chamber session or normal pressure oxygen breathing. This blood will be analyzed for neutrophil oxidative burst and cytokine analysis.
详细描述
The investigators are interested in studying the influence of hyperbaric oxygen on neutrophils (a kind of white blood cell) and cytokines (cell proteins). Hyperbaric oxygen can enhance the way the immune system works, but the investigators don't fully know how that happens. the investigators are doing this study to learn more about this question.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients (ages 18-65) presenting for an anticipated course of at least 4 hyperbaric oxygen sessions for chronic clinical indications (possible indications include diabetic lower extremity wounds or refractory osteomyelitis)
- •Diabetes mellitus
- •Current antibiotic use for active infection
排除标准
- •Prior treatment with hyperbaric oxygen within the last 30 days
- •Consistent vitamin C or vitamin E supplementation in the past year
- •Active tobacco use
- •Pregnancy
- •Cohort 2: Hyperbaric patients without diabetes or active infection
- •Inclusion Criteria:
- •Adult patients (ages 18-65) presenting for an anticipated course of at least 4 hyperbaric oxygen sessions for chronic clinical indications (possible indications include crush injury, acute peripheral arterial insufficiency, or radiation necrosis)
- •Exclusion Criteria:
- •Prior treatment with hyperbaric oxygen within the last 30 days
- •Consistent vitamin C or vitamin E supplementation in the past year
- •Active tobacco use
- •Pregnancy
- •Diabetes mellitus
- •Known or suspected viral or bacterial infection
- •Cohort 3: Critically ill hyperbaric patients with acute infection
- •Inclusion Criteria:
- •Adult patients (ages 18-65) admitted to the intensive care unit for acute, life-threatening infection where hyperbaric oxygen is clinically indicated for at least 4 sessions (possible indications include gas gangrene or necrotizing fasciitis)
- •Exclusion Criteria:
- •Prior treatment with hyperbaric oxygen within the last 30 days
- •Consistent vitamin C or vitamin E supplementation in the past year
- •Active tobacco use
- •Pregnancy
- •Carbon monoxide-poisoned patients
- •Inclusion Criteria:
- •Adult patients (ages 18-65) presenting for hyperbaric oxygen for acute carbon monoxide poisoning (up to 3 sessions)
- •Exclusion Criteria:
- •Prior treatment with hyperbaric oxygen within the last 30 days
- •Consistent vitamin C or vitamin E supplementation in the past year
- •Active tobacco use
- •Pregnancy
- •Time interval between removal from carbon monoxide source and first hyperbaric oxygen session >12 hours
- •Cohort 5: Diabetic research subjects also undergoing glucose tolerance testing
- •Inclusion Criteria:
- •Co-enrollment in glucose tolerance testing study
- •Meet inclusion/exclusion profile for that study
- •Exclusion Criteria:
- •Prior treatment with hyperbaric oxygen within the last 30 days
- •Consistent vitamin C or vitamin E supplementation in the past year
- •Active tobacco use
- •Cohort 6: Brain injury research subjects
- •Inclusion Criteria:
- •Co-enrollment in brain injury study
- •Meet inclusion/exclusion profile for that study
- •Exclusion Criteria:
- •Known or suspected viral or bacterial infection
- •Consistent vitamin C or vitamin E supplementation in the past year
- •Active tobacco use
- •Cohort 7: Hyperbaric chamber inside attendants
- •Inclusion Criteria:
- •Employees (ages 18-65) medically cleared to work as hyperbaric chamber inside attendants, reporting for a regular duty day
- 另有 30 项未显示
研究组 & 干预措施
Critically ill patients with infection
Adult patients with acute, life-threatening infection for which hyperbaric oxygen is clinically indicated will have blood drawn before and after their first and fourth clinical hyperbaric oxygen treatments.
干预措施: Hyperbaric Oxygen (Drug)
Diabetics with active, chronic infection
Adult patients with diabetes mellitus and current antibiotic use for active infection will have blood drawn before and after their first and fourth clinical hyperbaric oxygen treatments.
干预措施: Hyperbaric Oxygen (Drug)
No diabetes or infection
Adult patients without diabetes and not using antibiotics will have blood drawn before and after their first and fourth clinical hyperbaric oxygen treatments.
干预措施: Hyperbaric Oxygen (Drug)
Carbon monoxide patients
Adult patients with acute carbon monoxide poisoning will have blood drawn before and after their first clinical hyperbaric oxygen treatment.
干预措施: Hyperbaric Oxygen (Drug)
Glucose tolerance test
Diabetic patients co-enrolled in a hyperbaric oxygen and glucose control study will have blood drawn before and after their glucose tolerance test and their first clinical hyperbaric oxygen treatment.
干预措施: Hyperbaric Oxygen (Drug)
Brain injury research subjects
Research subjects co-enrolled in a study examining hyperbaric oxygen for post-concussive symptoms will have blood drawn before and after their first and fourth hyperbaric chamber sessions.
干预措施: Hyperbaric Oxygen (Drug)
Hyperbaric chamber inside attendants
Hyperbaric chamber inside attendants will have their blood drawn before, mid-session, and after their chamber exposure during their regular duty day. The hyperbaric chamber exposure will include hyperbaric air and hyperbaric oxygen components (hyperbaric air/oxygen).
干预措施: Hyperbaric Air/Oxygen (Other)
Volunteers, hyperbaric oxygen
Healthy adult volunteers will have blood drawn before and after a single hyperbaric chamber session.
干预措施: Hyperbaric Oxygen (Drug)
Volunteers, normobaric pressure
Healthy volunteers will have their blood drawn before and after breathing 100% oxygen at atmospheric pressure (normobaric oxygen) for 120 minutes.
干预措施: Normobaric oxygen (Other)
结局指标
主要结局
Oxidative Burst Assay
时间窗: Within 30 minutes after chamber session 1
次要结局
未报告次要终点
研究者
Lindell Weaver
Director, Hyperbaric Medicine
Intermountain Health Care, Inc.