ICU Predictive Score of WEaning Success in Patients At Risk of Extubation Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The primary outcome measure is extubation failure, defined as the need for reintubation within 72 hours of extubation.
研究概览
简要总结
Observational study in two medical-surgical intensive care units of the Clermont-Ferrand University Hospital to develop a composite score for prediction of 72h-extubation failure in patients at risk of extubation failure.
详细描述
In our intensive care units, when a patient does not have risk factors for extubation failure, SBT (Spontaneous Breathing Trial) in PSV (Pressure Support Ventilation) is usually performed first as recommended. If patient fails the first SBT in PSV or extubation, weaning is considered difficult (WIND study group AJRCCM 2017). In this case, the service protocol provides a T-piece SBT for the following SBT. In addition, this same protocol proposes to perform T-piece SBT from the first weaning event in patients with risk factors for WiPO (Weaning-induced Pulmonary Oedema), defined as obesity (BMI >30 kg/m2), COPD (Chronic Obstructive Pulmonary Disease) (suspected or known), or heart disease (structural [hypertrophic, dilated, valvular], functional [diastolic or systolic dysfunction], ischemic, or dysrhythmic).
Our study population concerns patients for whom a T-piece trial is performed according to the service protocol.
A patient is potentially includible in the study if he has been under mechanical ventilation for at least 48h and if he presents criteria of weanability with a planned T-piece SBT. As long as the inclusion and non-inclusion criteria are respected (see inclusion/non-inclusion criteria), clinical, biological and ultrasound data will be collected before and at the end of the ventilatory weaning test. If the patient fails the weaning test and/or is not extubated following the test, data from each new T-piece SBT will be collected within 7 days of inclusion.
The global management of the patient, before, during and after the inclusion of the patient in the study is the one usually practiced in our intensive care units, based on the national and international recommendations as well as the literature exposed in the protocol.
During the patient's stay in the ICU, data from the medical record will be collected (demographic, clinical, treatment, vital status,...). A follow-up at D7, D28 and D90 will be performed.
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
- •Age > 18 years
- •Invasive mechanical ventilation for at least 48 hours
- •Criteria for ventilatory weaning are present
- •T-piece spontaneous breathing trial planned
- •Patients with a social security program
排除标准
- •Patients already included in this study during the same stay in intensive care
- •Resuscitation neuromyopathy defined by an MRC (Medical Research Council) score < 48/60
- •Surgery planned within 72 hours
- •Prolonged ventilatory weaning (>7 days after the first SBT)
- •Patients with tracheostomy
- •Patients with non-reintubation decision or terminal extubation
- •Brain damaged patients
- •Patients with ECMO/ECLS
- •Tetraplegic or paraplegic patients with lesion level higher than T8
- •Nasotracheal intubated patients
- •Pregnant or breastfeeding women
- •Refusal to participate in the study (refusal by patient or family member/trusted person).
- •Patients under guardianship
结局指标
主要结局
The primary outcome measure is extubation failure, defined as the need for reintubation within 72 hours of extubation.
时间窗: 72 hours
次要结局
- Use of High Flow Nasal Oxygenation post-extubation(7 days)
- Mortality at day 7, 28 and 90(90 days)
- Time frame and reasons for reintubation in case of failed extubation.(28 days)
- Length of stay in intensive care(90 days)
- Use of non-invasive post-extubation ventilation(7 days)
- Number of days without mechanical ventilation from study inclusion to day 28(28 days)