Carbon Monoxide Encephalopathy, Carbon Monoxide-induced Parkinsonism, Carbon Monoxide Intoxication, Carbon Monoxide Poisoning
Conditions
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.
Interventions
DRUGsaline placebo
IV saline bolus
DRUGDexamethasone
10mg IV Dexamethasone
Sponsors
University of Nebraska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Pharmacy will provide either saline or 10mg dexamethasone in saline in a masked fashion so that the clinical staff are blinded.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Memory, Emotion, and Neurologic Symptoms | 6 weeks and 12 weeks post-treatment | Post-treatment phone followup |
Countries
United States
Contacts
CONTACTJeffrey S Cooper, MD
CONTACTBrooklin Zimmerman, MSN
PRINCIPAL_INVESTIGATORJeffrey S Cooper, MD
University of Nebraska
Outcome results
None listed