The Use of Self-reported Symptoms as a Proxy for Acute Organophosphate Poisoning Among Nepali Farmers: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- Change in self-reported acute organophosphate poisoning symptoms from baseline to follow up
研究概览
简要总结
The purpose of this study is to evaluate self-reported symptoms as a proxy for acute organophosphate poisoning by examining self-reported acute organophosphate poisoning symptoms and PchE activity in response to occupational acute organophosphate exposure among farmers in Nepal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •minimum age 18 years
- •hand pressured backpack sprayer usage
- •used to spray with moderately to extremely hazardous pesticides according to the World Health Organization's (WHO) Pesticide Hazard Classification
排除标准
- •usual personal protective equipment use (respirator/mask with particulate filter, face shield, googles, gloves, boots, plastic poncho)
- •unwilling to stay pesticide-free seven days prior to each of the two spray sessions
- •medical conditions interfering with PchE activity (liver disease, acute infection, chronic malnutrition, heart attack, cancer, obstructive jaundice, inflammation caused by various diseases, or use of pyridostigmine drugs)
结局指标
主要结局
Change in self-reported acute organophosphate poisoning symptoms from baseline to follow up
时间窗: Obtained just before (baseline) and 30 minutes after (baseline) each spray session
Obtained using a structured questionnaire interview. The definition of symptoms was based on WHO's standardized list of clinical presentations of acute organophosphate poisoning.
Change in Plasma Cholinesterase (PchE) activity from baseline to follow up
时间窗: Obtained just before (baseline) and 30 minutes after (baseline) each spray session
PchE activity was measured with a blood test using a Test-mate Che Cholinesterase System (Model 400) with a PchE Plasma Cholinesterase Assay Kit (Model 470).
次要结局
未报告次要终点
研究者
Dea Haagensen Kofod
MB
Bispebjerg Hospital