NCT06641752招募中不适用
Evaluation of the Accuracy of Capillary Versus Venous CO Measurement in Subjects With Suspected Carbon Monoxide Poisoning: a Prospective, Multicenter, Diagnostic, Controlled Study.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Determine the accuracy of capillary HbCO measurement (compared with venous or arterial HbCO) in patients with suspected CO poisoning.
研究概览
简要总结
The main goal of COCAP is to compare COHb (carboxyhemoglobin) levels measured from venous or arterial samples with those measured from capillary samples in patients suspected of Carbon Monoxide intoxication.Patient participation in the study will be limited to capillary sampling (approx. 5-15 minutes).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient admitted to emergency department
- •Presenting one or more clinical signs (asthenia, headache, nausea, vomiting, loss of consciousness, etc.) and a history compatible with CO intoxication (collective symptoms, notion of smoke, activation of a detector, etc.).
排除标准
- •Patients under protective supervision (safeguard of justice, curatorship, guardianship)
- •Incarcerated patients
- •Pregnant or breast-feeding women
- •Patients refusing to take part in the study
结局指标
主要结局
Determine the accuracy of capillary HbCO measurement (compared with venous or arterial HbCO) in patients with suspected CO poisoning.
时间窗: 15 minutes
The main goal will be determined by the mean bias and limits of agreement between capillary and venous (or arterial) sampling (Bland-Altman analysis).
次要结局
- Determine the diagnostic performance of capillary measurement(15 minutes)
- Assess the technical difficulties of different blood sampling processes (Measurement of the number of attempts and failure rate for samples)(15 minutes)
- Assess the technical difficulties of different blood sampling processes (Measurement of the time required to take each sample)(15 minutes)
- Analyse the technical difficulties associated with the analysis of the two samples (Time between sampling and HbCO result)(15 minutes)
- Analyse the technical difficulties associated with the analysis of the two samples (percentage of samples that cannot be analysed by the laboratory)(15 minutes)
研究者
研究点 (2)
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