Carbon Monoxide Hyperbaric Oxygen With Steroid Therapy

Phase 1

Not yet recruiting

• Conditions: Carbon Monoxide Poisoning; Carbon Monoxide Intoxication; Carbon Monoxide Encephalopathy; Carbon Monoxide-induced Parkinsonism
• Interventions: Drug: saline placebo; Drug: Dexamethasone

• Registration Number: NCT06574048
• Lead Sponsor: University of Nebraska

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.

Study Timeline

• Study First Submitted: 2024-08-22
• Study First Submitted QC: 2024-08-23
• Study First Posted: 2024-08-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-07
• Study Start: 2025-05
• Primary Completion: 2027-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyperbaric Oxygen Therapy with Placebo (Saline)	saline placebo	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.
Hyperbaric Oxygen Therapy with Dexamethasone	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.

Primary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment (MoCA)	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 Outcome Measures

Name	Time	Method
Memory, Emotion, and Neurologic Symptoms	6 weeks and 12 weeks post-treatment	Post-treatment phone followup

Trial Locations

Locations (1)

Nebraska Medicine, Hyperbaric Medicine Program, Clarkson Tower; 🇺🇸 Omaha, Nebraska, United States