Hyperbaric Oxygen, Neutrophil-oxidative Burst, and Cytokines (O2B)

Intermountain Health Care, Inc.

Status and phase

Enrolling

Phase 1

Conditions

Infection

Treatments

Other: Hyperbaric Air/Oxygen

Other: Normobaric oxygen

Drug: Hyperbaric Oxygen

Study type

Interventional

Funder types

Other

Identifiers

NCT02563678

1040229

Details and patient eligibility

About

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.

Full description

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 9 patient groups

Diabetics with active, chronic infection

Active Comparator group

Description:

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.

Treatment:

Drug: Hyperbaric Oxygen

No diabetes or infection

Active Comparator group

Description:

Adult patients without diabetes and not using antibiotics will have blood drawn before and after their first and fourth clinical hyperbaric oxygen treatments.

Treatment:

Drug: Hyperbaric Oxygen

Critically ill patients with infection

Active Comparator group

Description:

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.

Treatment:

Drug: Hyperbaric Oxygen

Carbon monoxide patients

Active Comparator group

Description:

Adult patients with acute carbon monoxide poisoning will have blood drawn before and after their first clinical hyperbaric oxygen treatment.

Treatment:

Drug: Hyperbaric Oxygen

Glucose tolerance test

Active Comparator group

Description:

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.

Treatment:

Drug: Hyperbaric Oxygen

Brain injury research subjects

Experimental group

Description:

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.

Treatment:

Drug: Hyperbaric Oxygen

Hyperbaric chamber inside attendants

Experimental group

Description:

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).

Treatment:

Other: Hyperbaric Air/Oxygen

Volunteers, hyperbaric oxygen

Active Comparator group

Description:

Healthy adult volunteers will have blood drawn before and after a single hyperbaric chamber session.

Treatment:

Drug: Hyperbaric Oxygen

Volunteers, normobaric pressure

Experimental group

Description:

Healthy volunteers will have their blood drawn before and after breathing 100% oxygen at atmospheric pressure (normobaric oxygen) for 120 minutes.