Gestion du Sevrage de la Ventilation mécanique du Patient neurolésé en réanimation et Association Avec le Devenir. Etude Observationnelle Multi-centrique Internationale. Extubation Strategies in Neuro-Intensive Care Unit Patients and Associations With Outcome. The International Observational ENIO Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,750
- 试验地点
- 6
- 主要终点
- Extubation success
研究概览
简要总结
Rationale Prolonged mechanical ventilation (MV) is common in patients with severe Brain Injury (BI). Guidelines for the management of extubation are largely lacking for patients with BI, and the role of tracheostomy is highly uncertain. More important, data on practice of management of extubation is yet underreported, as is the use of tracheotomy in this specific subset of critical care patients.
Objective The objective of this prospective observational study is to describe the management of extubation and tracheostomy in intensive care unit (ICU) patients with BI. The aim is to describe the incidence of extubation failure and the rate of tracheostomy.
Study design The "Extubation strategies in Neuro-Intensive care unit patients, and associations with Outcomes (ENIO)" is an observational multicentre international cohort study.
Study population The investigators will include patients undergoing BI, with an initial Glasgow Coma Score ≤ 12 and with a delivered duration of mechanical ventilation (MV) ≥ 24 hours at ICU admission. The inclusion period will last 6 months in total, and each centre is expected to include at least 24 patients during this period. With over 60 ICUs participating worldwide, we expect to include 1500 patients.
Main parameters Parameters to be collected include: general neurological management, ventilatory management, general ICU complications, specific data on extubation and tracheostomy, general in-ICU outcomes and in-hospital mortality.
Nature and extent of the burden and risks associated with participation Because of the observational design of the study using routinely collected data, there is no additional burden for the patient. Collection of data from ICU charts and/or (written or electronic) medical records systems bears no risk to the patients.
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' old
- •Patients admitted in a ICU for a central neurological pathology, listed as follows, with estimated or clinically evaluated Glasgow Coma Score ≤12 before endo-tracheal intubation, with anomaly on brain CT-scan and requiring effective invasive mechanical ventilation ≥ 24 hours are eligible to the study:
- •Traumatic Brain Injury
- •Aneurysmal Subarachnoid haemorrhage
- •Intra-Cranial Haemorrhage
- •Ischemic Stroke
- •Central Nervous System Infection (Abscess, Empyema, Meningitides, Encephalitis...)
- •Brain Tumour
- •Patient with an attempt of extubation and/or performance of a tracheostomy
排除标准
- •Patients < 18 years' old
- •Patients with ongoing pregnancy
- •Patients with spine cord injury above T4
- •Resuscitated cardiac arrest
- •Withdrawal of Life-Sustaining Treatment (WLST) in the first 24 hours
结局指标
主要结局
Extubation success
时间窗: Extubation failure will be defined as the need to re-intubate the patient within 168hours (7 days) after removal
Successful removal of endo-tracheal tube
次要结局
- Tracheostomy(ICU stay (Median 15 days))
- In-ICU mortality(During ICU stay (Median 15 days))
- In-ICU VAP(Onset of VAP during ICU stay and after extubation failure, when appropriate (Median 15 days))
- Mechanical ventilation duration(ICU-stay (Median 15 days))
- In-hopsital mortality(During the first hospital stay following Brain-Injury (Median 25 days))