Is Transcutaneous Carbon Dioxide Pressure (tcPCO2) Monitoring During Spontaneous Breathing Trials Useful to Predict Extubation Failure in Mechanically Ventilated Patients in the ICU?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Difference between maximum and initial tcPCO2 (ΔtcPCO2) during SBTs in patients who fail extubation compared to patients who have been successfully extubated.
研究概览
简要总结
Difficult weaning from ventilation and extubation failure are major issues in intensive care, concerning 30% and 12% of patients respectively. These can be partly explained by the lack of accuracy of spontaneous breathing trial (SBT) failure criteria to predict extubation failure. The investigators performed a pilot study to evaluate transcutaneous carbon dioxide pressure (tcPCO2) monitoring during SBTs. The results showed that the difference between maximum and initial tcPCO2 (or ΔtcPCO2) was significantly higher in the group of patients who failed SBTs according to the usual criteria. Moreover, the results suggested that ΔtcPCO2 could be an accurate and early criterion for SBT failure. The size of the study could not examine ΔtcPCO2 regarding extubation failure. Therefore, the main objective of this study is to determine if Δ tcPCO2 during SBTs is associated with extubation failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Care providers will be blinded of tcPCO2 measurements to avoid influencing extubation decisions.
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
- •> 18 years old,
- •ICU indicated
- •invasive mechanical ventilation via orotracheal or nasotracheal intubation
- •presence of criteria for initiation of the weaning process as stated on our ICU's protocol
- •resolution of the disease leading to mechanical ventilation
排除标准
- •mechanical ventilation during less than 24 hours
- •Tracheotomy and tracheostomy at ICU admission
- •Pregnancy
- •Patient under legal protection
- •Patient enrolled in another study regarding weaning or CO2 metabolism
结局指标
主要结局
Difference between maximum and initial tcPCO2 (ΔtcPCO2) during SBTs in patients who fail extubation compared to patients who have been successfully extubated.
时间窗: 7 days
Extubation failure: need for reintubation, rescue non invasive ventilation or death within 7 days following extubation
次要结局
- Association between ΔtcPCO2 and extubation failure after adjustment on post extubation ventilation protocols (preventive non invasive ventilation or preventive Optiflow)(7 days)
- Adverse Events associated with tcPCO2 monitoring.(1 week)
- Determine if ΔtcPCO2 is an early predictor of extubation failure (happening before other criteria of failed SBT)(7 days)
- Association between extubation decisions and ΔtcPCO2.(1 week)
- Optimal ΔtcPCO2 threshold to predict extubation failure by a ROC curve.(7 days)
- Compare ROC curves obtained by different extubation failure predictors(7 days)
研究者
Henao Juliana
study coordinator
Versailles Hospital