Waveform Capnography and Colorimetric Carbon Dioxide Detection During Tracheal Intubation of Critically Ill Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,092
- 试验地点
- 15
- 主要终点
- Sensitivity of the test of exhaled carbon dioxide to detect a endotracheal tube positioned in the trachea.
研究概览
简要总结
This study will compare the sensitivity and specificity of waveform capnography versus colorimetric carbon dioxide detection to identify tracheal placement of the endotracheal tube during intubation of critically ill adults.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patient is located in a participating unit (ED or ICU)
- •Patient is undergoing tracheal intubation.
- •The clinician intends to use an exhaled CO2 detection device to confirm tracheal placement of the tube.
排除标准
- •Patient is known to be a prisoner
- •Patient is known to be < 18 years old
- •A responsible clinician has determined that sole use of either waveform capnography or colorimetric testing is required for optimal care of the patient.
结局指标
主要结局
Sensitivity of the test of exhaled carbon dioxide to detect a endotracheal tube positioned in the trachea.
时间窗: From intubation until 7 breaths from the ventilator are delivered, approximately 1 minute
The primary endpoint is the sensitivity of each test (against the reference standard) to accurately detect the tube location within the trachea. The sensitivity of each CO2 detection method describes the probability that the CO2 detection method is consistent with a tube location in the trachea for a patient who has an endotracheal tube located inside the trachea.
Sensitivity of the test of exhaled carbon dioxide to detect a endotracheal tube positioned in the trachea.
时间窗: From intubation until 7 breaths from the ventilator are delivered, approximately 1 minute
The co-primary endpoints are the sensitivity and specificity of each test (against the reference standard) to accurately detect the tube location. The sensitivity of each CO2 detection method describes the probability that the CO2 detection method is consistent with a tube location in the trachea for a patient who has an endotracheal tube located inside the trachea. The co-primary outcomes are a direct comparison of the sensitivity and specificity between the two index tests using McNemar's test with a two-sided P value with a significance level of 0.05. The McNemar's test is well-suited to paired data where both diagnostic tests are applied to the same patients. We will also present the absolute between-group difference with 95% confidence intervals.
次要结局
- Specificity of the test of exhaled carbon dioxide to detect a endotracheal tube positioned outside of the trachea.(From intubation until 7 breaths from the ventilator are delivered, approximately 1 minute)
研究者
Brian Driver
Co-Principal Investigator
Hennepin Healthcare Research Institute