The Value of Repeated Biomarker Measurements During an SBT to Predict Extubation Failure in Mechanically Ventilated ICU Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 181
- 试验地点
- 2
- 主要终点
- Extubation failure
研究概览
简要总结
The Value of Repeated BIOMarker Measurements During an SBT to Predict EXtubation Failure in Mechanically Ventilated ICU Patients
详细描述
Rationale: In order to prevent extubation failure or unnecessary prolonged ventilation, accurately predicting readiness for extubation is of key importance in ICU care. Currently, clinical criteria and spontaneous breathing trials (SBTs) are used to assess readiness for extubation. Data on the prognostic value of biomarkers in this setting are limited.
Objective: To investigate the association of biomarker measurements (NT-proBNP, hsTroponin-T, CKMB, myoglobin, GDF-15, CRP, IL-6, PCT, Cystatin-C, CA-125, galectin-3, ST-2, albumin) during an SBT with extubation failure in mechanically ventilated ICU patients.
Study design: Multi-centre prospective observational cohort study.
Study population: Adult ICU patients who are mechanically ventilated for more than 48 hours and fulfil readiness-to wean criteria.
Main study parameters/endpoints: Extubation failure (the need for reintubation within 7-days).
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
- •Aged ≥18 years
- •Mechanically ventilated for more than 48 hours
- •Fulfilling readiness-to wean criteria
- •Written informed consent from the patient or his/her legal representative
排除标准
- •Patients with risk factors for laryngeal oedema and a negative cuff leak test (indicating upper airway obstruction with need for steroid treatment)
- •Planned replacement of the endotracheal tube for a tracheostomy
- •Terminal illness
结局指标
主要结局
Extubation failure
时间窗: 7 days
The number of patients who were re-intubated within the next 7 days after extubation
All-cause mortality
时间窗: 7-days
The number of patients who died within 7 days after extubation
次要结局
- Rescue non-invasive ventilation or high-flow nasal oxygen for post-extubation respiratory insufficiency(7 days)
- Extubation failure within 48 hours and 72 hours(48 hours and 72 hours)
- All-cause mortality: ICU, hospital, 28-days, 3 and 12 months(28-days, 3 and 12 months)
- Major adverse cardiac event(3 and 12 months)
- ICU re-admission rate within current hospitalization(Up to 1 year)
- ICU length of stay post-extubation for medical reasons(Up to 1 year)
- Quality of life of patients after ICU and hospital admission(3 and 12 months)
研究者
Henrik Endeman
Principal Investigator
Erasmus Medical Center