Use of a Physiotherapy Assessment to Predict Extubation Failure in Mechanically Ventilated Patients: the EPIC Assessment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- extubation failure rate
研究概览
简要总结
"Weaning from mechanical ventilation is a crucial step in the intensive care unit. Several factors complicate weaning and increase the risk of failure. To predict the success of extubation, the spontaneous ventilation test (T-Tube) remains essential. Despite this, the failure rate is around 10-20%.
Failed extubation is not without consequences, since it increases the risk of pneumopathy and mortality. It therefore seems essential to identify potential extubation failures using effective predictive criteria. Several of these predictive criteria have been studied separately in the literature, but are still not widely used in practice. Many studies have sought to identify these predictive criteria, without actually linking them. However, when combined in a single assessment prior to extubation, they could represent a reliable prediction and decision-making aid.
In the intensive care unit at Hôpital Bichat Claude Bernard, a team of physiotherapists dedicated solely to this unit carries out a routine EPIC Assessment, combining several criteria, some of which have individually demonstrated their reliability in predicting extubation outcome. Physiotherapists are health professionals working as part of the intensive care team, and are well versed in issues relating to bronchial congestion, respiratory function and muscle strength, whether for breathing or locomotion. Similarly, their involvement in issues relating to swallowing disorders acquired in intensive care gives them an overall view of the patient's ability to protect his or her airway post-extubation. The EPIC Assessment has been designed by them to address these issues. With the help of this assessment, and by following the cut-offs of the various criteria, they link the different criteria making up the EPIC Assessment and communicate a ""favorable"" or ""unfavorable"" opinion for extubation.
Our hypothesis is that the EPIC Assessment is, in addition to its interpretation by physiotherapists, a reliable tool for predicting the outcome of extubation."
详细描述
Adult patients admitted to the ICU and placed on invasive mechanical ventilation for more than 48 hours will be screened by the investigators (physiotherapists in conjunction with a doctor).
The spontaneous ventilation test will be carried out in the T-Tube, on the basis of a medical decision and within the framework of care, if the patients meet the weaning conditions:
- No sedation
- No inotropes or vasopressors
- Consistent response to simple commands
- FiO2 < 50%
- PEEP < 5 cmH2O
The criteria for a successful T-Tube test are:
- FR < 35 cycles/min
- SpO2 > 90%,
- Variation of less than 20% in FR or systolic blood pressure,
- No sweating, agitation or vigilance disorders.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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 18 years of age or older
- •Admitted to intensive care and placed on invasive mechanical ventilation for more than 48 hours
- •Having passed a T-Tube spontaneous ventilation test < 24h
排除标准
- •Tracheostomized patient
- •Severe psychiatric pathology or cognitive disorders
- •Uncooperative patient
- •Patient under therapeutic restriction (terminal extubation)
- •Patient who has already participated in research
- •Patient or close relative (if patient not able) opposed to research
- •No relative if patient unable to receive information
结局指标
主要结局
extubation failure rate
时间窗: day 7 after extubation
次要结局
- Length of stay in post-extubation intensive care unit(1 month)
- "Favourable" or "unfavourable" rating by two assessors (physiotherapists) blind to the other assessor's rating(at extubation)
- Medical decision to extubate (or not) the patient following a positive (or negative) opinion from the physiotherapist(at extubation)
- Measurement of Maximum Inspiratory Pressure(before extubation)
- Measurement of Peak Expiratory Flow(before extubation)
- Binary global assessment: "favorable" or "unfavorable" opinion on extubation, given collectively by the caregivers in charge of the patient (physiotherapist, senior physician, junior physician (intern), state-registered nurse, nursing auxiliary).(at extubation)
- Rapid Shallow Breathing Index(before extubation)
- Measurement of Orofacial motor control(before extubation)
- Laryngeal lift(before extubation)
- extubation failure rate(72h after extubation)
- Total length of hospital stay post-extubation(1 month)
- in-hospital death rate(1 month)
- Glasgow Coma Scale(The intubated patient's GCS does not take into account the verbal component, as the patient is unable to speak.)
- Measurement of Bronchial congestion(before extubation)
- Measurement of Salivary stasis(before extubation)
- Measurement of Nausea reflex(before extubation)
- Measurement of Cervical spine flexion(before extubation)
- Medical Research Council(before extubation)