Air Leak Test in Pediatric Intensive Care Unit : a Multicentric and Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 19
- 主要终点
- Respiratory distress by post-extubation upper airway obstruction (UAO)
研究概览
简要总结
Respiratory distress by upper airway obstruction (UAO) is the primary etiology of extubation failure in children hospitalized in pediatric intensive care unit (PICU).
This complication may require various invasive therapeutic which increase morbi-mortality and length of hospital stay.
Cuff leak test (CLT) measured prior extubation to predict post-extubation UAO has been widely used in adult. The test compared expired tidal volume with cuff inflated and cuff deflated in order to predict UAO.
Despite its frequent use in PICU, his predictive value to predict UAO in children is still poorly documented.
Therefore, we conducted the first multicentric, prospective study to evaluate the CLT as a predictor of post-extubation UAO in critically ill children.
The Primary objective is to assess the effectiveness of CLT in predicting severe respiratory distress by UAO within 48 hours of extubation in a critically ill children.
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
- 2 Days 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 2 day to < 18 years of age,
- •Ventilated through a cuffed endotracheal tube,
- •Expected duration of mechanical ventilation ≥ 24 hours,
- •Having a cuff leak test prior extubation,
- •Placed on the assist control setting during CLT,
- •No opposition from parents or patient
排除标准
- •Receiving mechanical ventilation via a tracheostomy,
- •Unplanned extubation,
- •Patient with long-term non-invasive ventilation (NIV),
- •History of upper airways pathology,
- •Surgery of upper airways less than 1 month old,
- •Limitations of medical care in place,
- •Parents or patient opposition,
- •Already been included in this study,
- •Not affiliated with social security.
结局指标
主要结局
Respiratory distress by post-extubation upper airway obstruction (UAO)
时间窗: within 48 hours
The respiratory distress will be assessed using the Westley score. The Westley score evaluates the severity of respiratory function by assessing five factors: level of consciousness, cyanosis, stridor, air entry, and retractions. A specific point values are given for each factor, and the final score sum has a range from 0 to 17. The greater the respiratory distress the more imminent the respiratory distress. Respiratory distress will be defined by a Westley score greater than or equal to 4 with a minimum of 1 for the "stridor" item, at the initiation of at least one of the following treatments (IVC, LNHD, NIV (CPAP, BiPAP or any other mode with two pressure levels), MV(reintubation or tracheotomy)).
次要结局
- Cumulative incidence of return to mechanical ventilation (after re-intubation)(within 48 hours)
- Risk factors of severe respiratory distress (RD)(within 48 hours)
- Proportion of patients with intravenous corticosteroid therapy (IVC)(at inclusion)
- Predictive score for severe respiratory distress (RD)(within 48 hours)
- Median length of stay in paediatric intensive care(Up to 28 days)