Optimizing Hyperbaric Oxygen Treatments for Acute Carbon Monoxide Poisoning: An Open-label Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Proportion of patients experiencing delayed neurologic sequalae
研究概览
简要总结
The optimal treatment strategy with hyperbaric oxygen therapy has been the subject of some debate over the past 3 decades. Initial landmark studies showed a decrease in the incidence of DNS with a single treatment and also with three treatments over the course of 24 hours. These two strategies have continued to be used widely without further evidence comparing them in a direct fashion. Retrospective publications in the years since have been largely conflicting about the benefit of additional hyperbaric treatments. The investigators would seek to randomize patients with carbon monoxide poisoning to receive with 1 or 3 treatments with hyperbaric oxygen and measure their neurologic outcomes.
详细描述
HBO is a niche treatment modality, especially in Canada. There are few sites which offer this care, and as such, treatment often carries significant logistical challenges. Since 2021, the HBO unit at the Misericordia hospital has averaged 49 patients per year being treated for CO poisoning. This HBO unit provides coverage to patients within Alberta, Saskatchewan, Manitoba, Yukon, and Northwest Territories. Due to the significant barriers to treatment, including the high cost to the public system, it is important to clearly understand how to best treat these patients.
Purpose:
The aim of this study is to assess whether a single treatment session of hyperbaric oxygen is non-inferior to three treatments for patients with acute carbon monoxide poisoning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult (over 17 years old) patients referred to a Hyperbaric Unit for acute carbon monoxide poisoning.
排除标准
- •Mechanically ventilated
- •Incarcerated
- •Cognitively impaired (acutely or chronically)
研究组 & 干预措施
Single HBO treatment
The exact parameters of each dive will be left to individual clinicians. Commonly used treatments would be:
1 treatment: 100% oxygen at 2.8 atmospheres for 30 minutes followed by a 10-minute air break, then 100% oxygen at 2 atmospheres for 60 minutes with one 10-minute air break after 30 minutes
干预措施: Hyperbaric Oxygen Therapy (Procedure)
Three HBO treatments
The exact parameters of each dive will be left to individual clinicians. Commonly used treatments would be:
3 treatments: Weaver protocol or similar variation (i.e. 100% oxygen at 3 atmospheres for 90 minutes with two 10-minute air breaks every 30 minutes. This will be repeated every 8 hours until 3 treatments are complete.)
干预措施: Hyperbaric Oxygen Therapy (Procedure)
结局指标
主要结局
Proportion of patients experiencing delayed neurologic sequalae
时间窗: 6 weeks and 6 months
DNS includes a spectrum of symptoms such as depression, anxiety, memory issues, ataxia, behavioral changes, decreased cognitive function. For CO-poisoned patients who do not succumb to the direct effects of hypoxia, DNS is one of the primary causes of long-term morbidity. The presence of delayed neurologic sequelae as measured by a series of standardized tests. These tests will include digit span (Attention), the Boston Naming Test 15 (aphasia), general orientation and delayed recall (memory), and clock drawing (visuospatial). DNS will be considered present if a patient scores ≥2 SD below the standardized T scores for any neuropsychological test, if they score ≥1 SD below the standardized T scores for 2 or more tests, or if they score ≥1 SD below the standardized T score for any test and self-report poor memory/concentration/attention.
次要结局
未报告次要终点