Carbon Monoxide Hyperbaric Oxygen With Steroid Therapy

NCT06574048 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: 0564-24-FB
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Hyperbaric Oxygen Therapy (HBO) is routine treatment of carbon monoxide (CO) poisoning to prevent delayed neurological sequelae. This study looking to see if neurologic outcomes are improved with the addition of dexamethasone. CO poisoning can initiate a free radical mediated process that can instigate a demyelinating process resulting in long term neurological sequelae in some, but not all patients. In other demyelinating disorders, steroids are a part of first line treatment. HBO is already used for acute CO poisoning, so this pilot study will try to ascertain if the addition of steroids in concert with each hyperbaric oxygen session will yield improved outcomes.

Conditions

Carbon Monoxide-induced Parkinsonism; Carbon Monoxide Poisoning; Carbon Monoxide Intoxication; Carbon Monoxide Encephalopathy

Outcome Measures

Primary Outcomes (1)

• Montreal Cognitive Assessment (MoCA)

  The Montreal Cognitive Assessment (MoCA) is a rapid screening instrument for mild cognitive dysfunction that assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuo-constructional skills, conceptual thinking, calculations, and orientation. The MoCA will be given in person while inpatient and via phone after discharge. Scored 0-30 Normal Cognitive performance 26 and above Mild impairment 18-25 Moderate impairment 10-17 Severe impairment 0-9

  Prior to hospital discharge after HBO therapy is no longer clinically warranted, and post-discharge at 2 weeks, 6 weeks, and 12 weeks.

Secondary Outcomes (1)

• Memory, Emotion, and Neurologic Symptoms

  6 weeks and 12 weeks post-treatment

Study Arms (2)

Hyperbaric Oxygen Therapy with Dexamethasone

EXPERIMENTAL

Participants will be treated with hyperbaric oxygen (HBO) therapy within three days of acute carbon monoxide poisoning. Treatment is a minimum of three inpatient sessions. Participants will also receive 10 mg dexamethasone per day while receiving HBO therapy (minimum of two doses, maximum of five doses if participants' stay is longer than three days). After three treatment sessions, participants will discharge home, barring no other medical complications requiring further hospitalization. In addition, continued HBO therapy plus steroids will be offered if participants are still dealing with CO poisoning sequelae as determined by study outcome measures.

Drug: Dexamethasone

Hyperbaric Oxygen Therapy with Placebo (Saline)

PLACEBO COMPARATOR

Participants will be treated with hyperbaric oxygen (HBO) therapy within three days of acute carbon monoxide poisoning. Treatment is a minimum of three inpatient sessions. Participants will also a saline placebo instead of dexamethasone while receiving HBO therapy. After three treatment sessions, participants will discharge home, barring no other medical complications requiring further hospitalization. In addition, continued HBO therapy plus steroids will be offered if participants are still dealing with CO poisoning sequelae as determined by study outcome measures.

Drug: saline placebo

Interventions

saline placebo DRUG

IV saline bolus

Also known as: nebulized normal saline (NS) placebo

Hyperbaric Oxygen Therapy with Placebo (Saline)

Dexamethasone DRUG

10mg IV Dexamethasone

Also known as: Ozurdex, Maxidex, DexPak 10 day, DexPak 6 Day, LoCort, DoubleDex, ReadySharp dexamethasone, DexPak 13 Day, ZonaCort

Hyperbaric Oxygen Therapy with Dexamethasone

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute CO poisoning, intentional or non-intentional exposure, receiving HBO treatment during hospitalization
• Age \>18 years
• Nebraska Medicine admission

You may not qualify if:

• Mechanical ventilation
• No hospital admission or admission to hospital Critical Care Medicine Service
• Allergy to dexamethasone
• Pre-Existing neurological condition confounding outcome determination

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

Nebraska Medicine, Hyperbaric Medicine Program, Clarkson Tower

Omaha, Nebraska, 68105, United States

Location

MeSH Terms

Conditions

Carbon Monoxide Poisoning

Interventions

Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Gas Poisoning; Poisoning; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Jeffrey S Cooper, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey S Cooper, MD

CONTACT

402-552-2490; jeffrey.cooper@unmc.edu

Brooklin Zimmerman, MSN

CONTACT

402-559-5237; brooklin.zimmerman@unmc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Pharmacy will provide either saline or 10mg dexamethasone in saline in a masked fashion so that the clinical staff are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 27, 2024
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 17, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)