Hyperbaric Oxygen, Neutrophil-oxidative Burst, and Cytokines

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Hyperbaric Oxygen, Neutrophil-oxidative Burst, and Cytokines: a Pilot Study

Conditions
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Infection

Intervention / Treatment
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* Drug: Hyperbaric Oxygen
* Other: Hyperbaric Air/Oxygen
* Other: Normobaric oxygen


Participation Criteria
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Eligibility Criteria
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Cohort 1: Diabetic hyperbaric patients with active, chronic 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 diabetic lower extremity wounds or refractory osteomyelitis) Diabetes mellitus Current antibiotic use for active infection 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 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 Cohort 4: 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 Exclusion Criteria: Known or suspected viral or bacterial infection Consistent vitamin C or vitamin E supplementation in the past year Active tobacco use Prior work in the hyperbaric chamber in the last 72 hours Cohort 8: Healthy volunteers to receive hyperbaric oxygen Inclusion Criteria: Healthy volunteers (ages 18-65) Medical clearance for hyperbaric oxygen exposure Exclusion criteria: Hyperbaric oxygen exposure within the last 30 days Active chronic medical condition Use in the past 30 days of any over-the-counter or prescription medication or dietary supplement beyond a general multivitamin Active tobacco use History of significant health problems, including metabolic bone disease, skeletal muscle pathologies, cardiac or peripheral cardiovascular system abnormalities, clotting disorders, coronary artery disease, peripheral vascular disease, stroke, cancer, high cholesterol or triglycerides, high blood pressure, diabetes mellitus, or impaired liver/kidney function. Morbidly obese (body mass index > 40 kg/m2) Pregnancy Known or suspected viral or bacterial infection Cohort 9: Healthy volunteers to breathe 100% oxygen at atmospheric pressure Inclusion Criteria: - Healthy volunteers (ages 18-65) Exclusion criteria: Hyperbaric oxygen exposure within the last 30 days Active chronic medical condition Use in the past 30 days of any over-the-counter or prescription medication or dietary supplement beyond a general multivitamin Active tobacco use History of significant health problems, including metabolic bone disease, skeletal muscle pathologies, cardiac or peripheral cardiovascular system abnormalities, clotting disorders, coronary artery disease, peripheral vascular disease, stroke, cancer, high cholesterol or triglycerides, high blood pressure, diabetes mellitus, or impaired liver/kidney function. Morbidly obese (body mass index > 40 kg/m2) Pregnancy Known or suspected viral or bacterial infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diabetics with active, chronic infection<br>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. | Drug: Hyperbaric Oxygen<br>* Hyperbaric oxygen therapy<br>* Other names: HBO, HBO2;|
| Active Comparator: No diabetes or infection<br>Adult patients without diabetes and not using antibiotics will have blood drawn before and after their first and fourth clinical hyperbaric oxygen treatments. | Drug: Hyperbaric Oxygen<br>* Hyperbaric oxygen therapy<br>* Other names: HBO, HBO2;|
| Active Comparator: Critically ill patients with infection<br>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. | Drug: Hyperbaric Oxygen<br>* Hyperbaric oxygen therapy<br>* Other names: HBO, HBO2;|
| Active Comparator: Carbon monoxide patients<br>Adult patients with acute carbon monoxide poisoning will have blood drawn before and after their first clinical hyperbaric oxygen treatment. | Drug: Hyperbaric Oxygen<br>* Hyperbaric oxygen therapy<br>* Other names: HBO, HBO2;|
| Active Comparator: Glucose tolerance test<br>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. | Drug: Hyperbaric Oxygen<br>* Hyperbaric oxygen therapy<br>* Other names: HBO, HBO2;|
| Experimental: Brain injury research subjects<br>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. | Drug: Hyperbaric Oxygen<br>* Hyperbaric oxygen therapy<br>* Other names: HBO, HBO2;|
| Experimental: Hyperbaric chamber inside attendants<br>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). | Other: Hyperbaric Air/Oxygen<br>* Breathing air inside a hyperbaric chamber, then breathing oxygen inside a hyperbaric chamber<br>|
| Active Comparator: Volunteers, hyperbaric oxygen<br>Healthy adult volunteers will have blood drawn before and after a single hyperbaric chamber session. | Drug: Hyperbaric Oxygen<br>* Hyperbaric oxygen therapy<br>* Other names: HBO, HBO2;|
| Experimental: Volunteers, normobaric pressure<br>Healthy volunteers will have their blood drawn before and after breathing 100% oxygen at atmospheric pressure (normobaric oxygen) for 120 minutes. | Other: Normobaric oxygen<br>* Breathing 100% oxygen at normal, atmospheric pressure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxidative Burst Assay |  | Within 30 minutes after chamber session 1 |