Clinical Trials Logo

Clinical Trial Summary

Hyperbaric oxygen therapy (HBO2) is recommended for symptomatic patients within 24 h of carbon monoxide (CO) poisoning. However, previous major studies found significantly better outcomes with HBO2 in patients treated within 6 h. Currently, there is no consensus on a CO poisoning-to-HBO2 interval that would not be beneficial. Therefore, the investigators aimed to evaluate the difference in therapeutic effect depending on the poisoning-to-HBO2 interval after CO exposure in patients with acute CO poisoning who received HBO2 within 24 h. The investigators compared the neurocognitive outcomes of patients according to HBO2 time intervals based on the outcomes of patients treated within 6 h (control group) with propensity score matching using the CO poisoning registry of our hospital.


Clinical Trial Description

In the United States, 50,000 patients with carbon monoxide (CO) poisoning are admitted to the hospital emergency departments annually, resulting in 1,500 deaths. CO poisoning can have serious neurologic sequelae. Immediate treatment, within 24 h after poisoning, is a reasonable recommendation for patients with CO poisoning. Most physicians do not treat with hyperbaric oxygen therapy (HBO2) 24 h after CO poisoning. Weaver et al. conducted a double-blind randomized control trial (RCT) satisfying all Consolidated Standards for the Reporting of Trials guidelines, which showed that HBO2 significantly reduced the rate of cognitive sequelae than normobaric oxygen therapy (NBO2) 6 weeks and 12 months post-treatment in patients with acute symptomatic CO poisoning. Although the aforementioned study used a maximum poisoning-to-HBO2 interval of 24 h in the inclusion criteria, more than 60% of enrolled patients were treated with HBO2 in less than 6 h after CO poisoning and the mean poisoning-to-HBO2 time was 5.8 h. In addition, in a subgroup with poisoning-to-HBO2 interval > 6 h, the mean interval was 8.6 h. Therefore, their study results were actually powered to determine the benefit of HBO2 within 6 h post-CO poisoning; hence, it is unknown whether HBO2 reduces the neurocognitive sequelae occurrence rate if performed beyond 6-12 h from CO poisoning. Currently, there is no consensus on a CO poisoning-to-HBO2 interval that would not be beneficial. Therefore, the investigators aimed to evaluate the difference in therapeutic effect depending on the poisoning-to-HBO2 interval after CO exposure in patients with acute CO poisoning who received HBO2 within 24 h. The investigators compared the neurocognitive outcomes of patients according to HBO2 time intervals based on the outcomes of patients treated within 6 h (control group) with propensity score matching to make tight adjustments to significant differences in patient baseline characteristics using the CO poisoning registry of our hospital. The investigators classified the patients included in the study into two groups: an early group (≤ 6 h, control group) and a late group (6-24 h, case group), based on the time from patient rescue from CO source to the start of the first HBO2 session. In addition, patients who received HBO2 at 6-24 h were divided into case 1 group (> 6 h and ≤ 12 h) and case 2 group (≥ 12 h and ≤ 24 h), and outcomes were compared with those of patients who received HBO2 within 6 h from CO exposure. Moreover, the investigators classified poisoning severity based on the necessity for intubation; mildly and severely poisoned patients were defined as those not requiring and requiring intubation, respectively ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04656912
Study type Observational
Source Wonju Severance Christian Hospital
Contact
Status Completed
Phase
Start date September 1, 2020
Completion date October 30, 2020

See also
  Status Clinical Trial Phase
Completed NCT03669848 - Is Transcutaneous Carbon Monoxide Saturation of E-cigarette Users Comparable to That of Smokers?
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)
Withdrawn NCT04118491 - Hyperbaric Oxygen for Carbon Monoxide Induced Chronic Encephalopathy N/A
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