Carbon Monoxide Hyperbaric Oxygen With Steroid Therapy

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of Nebraska

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Acute CO poisoning, intentional or non-intentional exposure, receiving HBO treatment during hospitalization

Age >18 years

Nebraska Medicine admission

Disqualifiers

Mechanical ventilation

No hospital admission or admission to hospital Critical Care Medicine Service

Allergy to dexamethasone

Pre-Existing neurological condition confounding outcome determination

Trial design

Design model

Parallel

Treatments tested in this trial

  • saline placebo

    Drug

    IV saline bolus

  • Dexamethasone

    Drug

    10mg IV Dexamethasone

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Hyperbaric Oxygen Therapy with DexamethasoneExperimental treatment 1 intervention
Group B: Hyperbaric Oxygen Therapy with Placebo (Saline)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Montreal Cognitive Assessment (MoCA)

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

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.

Secondary outcomes

1

Memory, Emotion, and Neurologic Symptoms

Post-treatment phone followup

Time frame
6 weeks and 12 weeks post-treatment

Other outcomes

Sponsors and contacts

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