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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02563678
Other study ID # 1040229
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date April 2015
Est. completion date December 2023

Study information

Verified date August 2022
Source Intermountain Health Care, Inc.
Contact Lindell K Weaver, MD
Phone 801-408-3623
Email lindell.weaver@imail.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Hyperbaric Oxygen
Hyperbaric oxygen therapy
Other:
Hyperbaric Air/Oxygen
Breathing air inside a hyperbaric chamber, then breathing oxygen inside a hyperbaric chamber
Normobaric oxygen
Breathing 100% oxygen at normal, atmospheric pressure

Locations

Country Name City State
United States Intermountain Medical Center Murray Utah
United States Intermountain Healthcare, LDS Hospital Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
Intermountain Health Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Oxidative Burst Assay Within 30 minutes after chamber session 1
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