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NCT Number: NCT06574048

Carbon Monoxide Hyperbaric Oxygen With Steroid Therapy

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Nebraska Medicine, Hyperbaric Medicine Program, Clarkson Tower

Omaha, Nebraska, 68105, United States

Location contact

Jeffrey S Cooper, MD

CONTACT

[email protected]

402-552-2490

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saline placebo

Drug

IV saline bolus

Other names: nebulized normal saline (NS) placebo

Dexamethasone

Drug

10mg IV Dexamethasone

Other names: Ozurdex, Maxidex, DexPak 10 day, DexPak 6 Day, LoCort, DoubleDex, ReadySharp dexamethasone, DexPak 13 Day, ZonaCort

Primary outcomes

  1. Montreal Cognitive Assessment (MoCA)

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

    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

Secondary outcomes

  1. Memory, Emotion, and Neurologic Symptoms

    Time frame: 6 weeks and 12 weeks post-treatment

    Post-treatment phone followup

Study contacts

Contact information is provided by the study sponsor or research team.

Brooklin Zimmerman, MSN

CONTACT

[email protected]

402-559-5237

Jeffrey S Cooper, MD

CONTACT

[email protected]

402-552-2490

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study title

Trial of Dexamethasone vs Placebo as an Adjunctive Therapy to Hyperbaric Oxygen Treatment HBO in Patients With Acute Carbon Monoxide Poisoning

Acronym: CODex

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 27, 2024
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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