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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Infection
• Intervention / Treatment: Drug: Hyperbaric Oxygen; Other: Hyperbaric Air/Oxygen; Other: Normobaric oxygen

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Susan Churchill, APRN-NP; Phone Number: 801-408-3623; Email: susan.churchill@imail.org

Study Locations

• United States
  • Utah
    • Murray, Utah, United States, 84157
      • Recruiting
      • Intermountain Medical Center
      • Contact: Susan Churchill, APRN-NP; Phone Number: 801-408-3623; Email: susan.churchill@imail.org
      • Principal Investigator: Lindell K. Weaver, MD
    • Salt Lake City, Utah, United States, 84143
      • Recruiting
      • Intermountain Healthcare, LDS Hospital
      • Contact: Susan Churchill, APRN-NP; Phone Number: 810-408-3623; Email: Susan.Churchill@imail.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Hyperbaric Oxygen; Hyperbaric oxygen therapy; Other Names: HBO, HBO2
Active Comparator: 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.	Drug: Hyperbaric Oxygen; Hyperbaric oxygen therapy; Other Names: HBO, HBO2
Active Comparator: 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.	Drug: Hyperbaric Oxygen; Hyperbaric oxygen therapy; Other Names: HBO, HBO2
Active Comparator: Carbon monoxide patients; Adult patients with acute carbon monoxide poisoning will have blood drawn before and after their first clinical hyperbaric oxygen treatment.	Drug: Hyperbaric Oxygen; Hyperbaric oxygen therapy; Other Names: HBO, HBO2
Active Comparator: 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.	Drug: Hyperbaric Oxygen; Hyperbaric oxygen therapy; Other Names: HBO, HBO2
Experimental: 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.	Drug: Hyperbaric Oxygen; Hyperbaric oxygen therapy; Other Names: HBO, HBO2
Experimental: 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).	Other: Hyperbaric Air/Oxygen; Breathing air inside a hyperbaric chamber, then breathing oxygen inside a hyperbaric chamber
Active Comparator: Volunteers, hyperbaric oxygen; Healthy adult volunteers will have blood drawn before and after a single hyperbaric chamber session.	Drug: Hyperbaric Oxygen; Hyperbaric oxygen therapy; Other Names: HBO, HBO2
Experimental: Volunteers, normobaric pressure; Healthy volunteers will have their blood drawn before and after breathing 100% oxygen at atmospheric pressure (normobaric oxygen) for 120 minutes.	Other: Normobaric oxygen; Breathing 100% oxygen at normal, atmospheric pressure

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: September 15, 2015
• First Submitted That Met QC Criteria: September 28, 2015
• First Posted (Estimate): September 30, 2015

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 1040229