University of Nebraska
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.
Carbon Monoxide Poisoning
Carbon Monoxide Intoxication
Carbon Monoxide Encephalopathy
Carbon Monoxide-induced Parkinsonism
saline placebo
Dexamethasone
PHASE1
PHASE2
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 Type : | INTERVENTIONAL |
Estimated Enrollment : | 20 participants |
Masking : | QUADRUPLE |
Masking Description : | Pharmacy will provide either saline or 10mg dexamethasone in saline in a masked fashion so that the clinical staff are blinded. |
Primary Purpose : | TREATMENT |
Official Title : | Trial of Dexamethasone vs Placebo as an Adjunctive Therapy to Hyperbaric Oxygen Treatment HBO in Patients With Acute Carbon Monoxide Poisoning |
Actual Study Start Date : | 2025-01 |
Estimated Primary Completion Date : | 2027-01 |
Estimated Study Completion Date : | 2028-01 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 19 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Nebraska Medicine, Hyperbaric Medicine Program, Clarkson Tower
Omaha, Nebraska, United States, 68105