Carbon Monoxide Hyperbaric Oxygen With Steroid Therapy

NCT ID: NCT06574048

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-01-31

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.

Detailed Description

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.

The control group will receive three HBO treatment sessions plus placebo. The treatment group will receive three HBO treatment sessions plus 10 mg Dexamethasone per day during HBO therapy (minimum of two doses, up to a maximum of five doses if participant stays for longer than three days). After three treatment sessions, the participant will be discharged home barring no other medical complications requiring further hospitalization. In two weeks, participants will return for follow-up testing and evaluation. Continued HBO therapy plus placebo as well as HBO therapy plus steroids for respective group members will be offered if participants are still dealing with CO poisoning sequelae as determined by our outcome measures. In addition, a 6 week and 12 week telephone follow-up will be conducted asking questions regarding memory, emotion, neurologic symptoms.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Hyperbaric Oxygen Therapy with Dexamethasone

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.

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: DRUG

10mg IV Dexamethasone

Hyperbaric Oxygen Therapy with Placebo (Saline)

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.

Group Type: PLACEBO_COMPARATOR

saline placebo

Intervention Type: DRUG

IV saline bolus

Interventions

saline placebo

IV saline bolus

Intervention Type: DRUG

Dexamethasone

10mg IV Dexamethasone

Intervention Type: DRUG

Other Intervention Names

nebulized normal saline (NS) placebo; Ozurdex, Maxidex, DexPak 10 day, DexPak 6 Day, LoCort, DoubleDex, ReadySharp dexamethasone, DexPak 13 Day, ZonaCort

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey S Cooper, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

Nebraska Medicine, Hyperbaric Medicine Program, Clarkson Tower

Omaha, Nebraska, United States

Countries

United States

Central Contacts

Jeffrey S Cooper, MD

Role: CONTACT

jeffrey.cooper@unmc.edu

402-552-2490

Brooklin Zimmerman, MSN

Role: CONTACT

brooklin.zimmerman@unmc.edu

402-559-5237

Facility Contacts

Jeffrey S Cooper, MD

Role: primary

jeffrey.cooper@unmc.edu

402-552-2490

Other Identifiers

0564-24-FB

Identifier Type: -

Identifier Source: org_study_id