NCT02563678

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2015

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

8.7 years

First QC Date

September 15, 2015

Last Update Submit

August 2, 2022

Conditions

Infection

Outcome Measures

Primary Outcomes (1)

  • Oxidative Burst Assay

    Within 30 minutes after chamber session 1

Study Arms (9)

Diabetics with active, chronic infection

ACTIVE COMPARATOR

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

No diabetes or infection

ACTIVE COMPARATOR

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

Critically ill patients with infection

ACTIVE COMPARATOR

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

Carbon monoxide patients

ACTIVE COMPARATOR

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

Drug: Hyperbaric Oxygen

Glucose tolerance test

ACTIVE COMPARATOR

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

Brain injury research subjects

EXPERIMENTAL

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 chamber inside attendants

EXPERIMENTAL

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

Volunteers, hyperbaric oxygen

ACTIVE COMPARATOR

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

Drug: Hyperbaric Oxygen

Volunteers, normobaric pressure

EXPERIMENTAL

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

Other: Normobaric oxygen

Interventions

Hyperbaric OxygenDRUG

Hyperbaric oxygen therapy

Also known as: HBO, HBO2
Brain injury research subjectsCarbon monoxide patientsCritically ill patients with infectionDiabetics with active, chronic infectionGlucose tolerance testNo diabetes or infectionVolunteers, hyperbaric oxygen
Hyperbaric Air/OxygenOTHER

Breathing air inside a hyperbaric chamber, then breathing oxygen inside a hyperbaric chamber

Hyperbaric chamber inside attendants
Normobaric oxygenOTHER

Breathing 100% oxygen at normal, atmospheric pressure

Volunteers, normobaric pressure

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • \- 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)
  • 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
  • \- 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)
  • Prior treatment with hyperbaric oxygen within the last 30 days
  • +48 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Intermountain Medical Center

Murray, Utah, 84157, United States

RECRUITING

Intermountain Healthcare, LDS Hospital

Salt Lake City, Utah, 84143, United States

RECRUITING

MeSH Terms

Conditions

Infections

Interventions

Hyperbaric OxygenationOxyhemoglobins

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeuticsHemoglobinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsGlobinsHemeproteins

Study Officials

  • Lindell K Weaver, MD

    Intermountain Health Care, Inc.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindell K Weaver, MD

CONTACT

801-408-3623lindell.weaver@imail.org

Susan Churchill, APRN-NP

CONTACT

801-408-3623susan.churchill@imail.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Hyperbaric Medicine

Study Record Dates

First Submitted

September 15, 2015

First Posted

September 30, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

August 4, 2022

Record last verified: 2022-08

Locations

US(2)