Clinical Trials Logo

Clinical Trial Summary

In some patients, a few days or weeks after recovery from carbon monoxide poisoning, new symptoms develop. These can affect mood, ability to think or remember clearly, and movements. Some people develop movement problems that are similar to Parkinson's disease. This damage to brain tissue is called "encephalopathy," and this study will look at the effect of pressurized oxygen therapy on long term, or chronic, encephalopathy.


Clinical Trial Description

Carbon monoxide (CO) poisoning is a leading cause of unintentional poisoning deaths in the United States. After a period of apparent recovery, survivors of acute CO-poisoning can develop a potentially permanent neurologic deterioration (DNS). DNS is a rare, poorly known encephalopathy with a 25-50% prevalence among severely poisoned CO-poisoned patients. Its symptoms and signs range from subtle abnormalities to severe dementia, Parkinsonism, gait disturbances, mutism, and incontinence. Recovery from delayed neuropsychiatric syndrome occurs in 50-75% of patients within 1 year. However, this leaves 25-50% permanently impaired. Hyperbaric oxygen therapy (HBO2) is useful after acute poisoning to reduce the chance of developing DNS. However, appropriate therapy for DNS is widely debated; particularly, the role of hyperbaric oxygen therapy (HBO2) after DNS has developed is controversial. This study proposes to ascertain whether hyperbaric oxygen is efficacious in the treatment of chronic DNS brain injury from carbon monoxide (CO) poisoning. Ten participants suffering from DNS for longer than one year will be recruited to the study, which will be prospective, blinded, sham-controlled and crossover in design. Participants will be divided into two groups of five. One group will receive 40 HBO2 treatments [100% oxygen at twice normal air pressure (2 ATA)] followed by 40 sham HBO2 treatments [air at near normal pressure (1.2 ATA)]. Treatments will be done once daily for 2 hours, Monday through Friday. Neurological and psychologic assessments will be done prior to starting treatments, after each group of 40 treatments. The second group will be treated similarly except that they will receive sham treatments in the first and oxygen treatments second. In this manner, all participants will act as both experimental and control subject and will receive treatment which we believe is therapeutic. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04118491
Study type Interventional
Source University of Nebraska
Contact
Status Withdrawn
Phase N/A
Start date July 2020
Completion date June 6, 2023

See also
  Status Clinical Trial Phase
Completed NCT03669848 - Is Transcutaneous Carbon Monoxide Saturation of E-cigarette Users Comparable to That of Smokers?
Completed NCT04656912 - Hyperbaric Oxygen Therapy Initiation Time in Acute Carbon Monoxide Poisoning
Recruiting NCT04975867 - Adjunct Targeted Temperature Management in Acute Severe Carbon Monoxide Poisoning N/A
Terminated NCT01100515 - Hyperbaric Oxygen Therapy for Acute Domestic Carbon Monoxide (CO) Poisoning Phase 3
Terminated NCT01099995 - Hyperbaric Oxygen Therapy for Comatose Patients With Acute Carbon Monoxide Poisoning Phase 3
Terminated NCT03017742 - Utility of Non-invasive Carboxyhemoglobin and Total Hemoglobin Measurement in the Emergency Department
Terminated NCT01059708 - Outcome Following Carbon Monoxide Poisoning in Children N/A
Recruiting NCT05591300 - Microparticles Blood Level in Acute Carbon Monoxide Poisoning
Not yet recruiting NCT04475263 - Cognitive and Blood Biomarker Assessment After CO Exposure
Completed NCT03926494 - Carbon Monoxide-induced Coma: Prognostic Factors
Recruiting NCT02375126 - Normal Quantitative EEG (qEEG) Dataset
Completed NCT03342209 - Utility of High Flow Nasal Cannula in CO Toxicity N/A
Completed NCT00465855 - One vs. Three Hyperbaric Oxygen Treatments for Acute Carbon Monoxide Poisoning Phase 4
Recruiting NCT04490317 - CARbon monoxidE intoxiCatiOn in Korea: Prospective Cohort (CARE CO Cohort)
Unknown status NCT00841165 - Carbon Monoxide Monitoring and Emergency Treatment N/A
Withdrawn NCT00280579 - Cyanide Poisoning in Fire Victims N/A
Enrolling by invitation NCT02483650 - Hyperbaric Oxygen Therapy Registry
Completed NCT05088005 - Prognostic Biomarkers in CO Poisoning
Completed NCT03030833 - Dysfunctional Hemoglobin Pulse Oximetry N/A
Recruiting NCT02860455 - Role of Pulse Co-oximetry for Detecting Carbon Monoxide Poisoning in the Prehospital Emergency Medical Service Setting N/A