Assessment of Airway Opening Pressure in Invasively Ventilated Children
概览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Feasibility of the two methods of measuring airway opening pressure
概览
简要总结
Acute respiratory distress syndrome (ARDS) in children is associated with significant morbidity and mortality. Current studies seek to individualize the management of children by defining several phenotypes, based until now mainly on clinical presentation. A better understanding of the respiratory mechanics of each patient could allow the individualization of other phenotypes and adapt their management with individualized ventilation. The method for detecting airway opening pressure (AOP) in children has not yet been validated and the reference methods in adults are difficult to apply in children due to their physiological particularities.
The main objective of the study is to evaluate the feasibility of two methods for measuring airway opening pressure in invasively ventilated pediatric patients.
详细描述
Acute respiratory distress syndrome (ARDS) in children is associated with significant morbidity and mortality. Current studies seek to individualize the management of children by defining several phenotypes, based until now mainly on clinical presentation. A better understanding of the respiratory mechanics of each patient could allow the individualization of other phenotypes and adapt their management with individualized ventilation. The method for detecting airway opening pressure (AOP) in children has not yet been validated and the reference methods in adults are difficult to apply in children due to their physiological particularities.
The main objective of the study is to evaluate the feasibility of two methods for measuring airway opening pressure in invasively ventilated pediatric patients: "pediatric slow flow method" based on a recent bench study and "fixed flow method" based on an adult study. The two methods will be separated by a wash out.
The method will be considered feasible if at least one on three measures can be interpretated.
Air flow will be recorded using a pneumotachograph connected to a T piece.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minor patients aged \> 1 year hospitalized in the pediatric intensive care unit at Necker-Enfants Malades Hospital and receiving invasive ventilation. To assess patients with acute respiratory distress syndrome, the PALICC-2 criteria are used.
- •Holders of parental authority must be informed and consent to their child's participation in the study.
- •The patient must be passively ventilated to ensure reliable measurements. This means that the patient must not be spontaneously ventilating and must be completely passively ventilated by the ventilator (no respiratory effort during long-term inflation).
排除标准
- •Respiratory mechanics preventing interpretation of maneuvers (flow too low and/or resistance too high)
- •Patient \< 10 kg and/or child under 1 year of age
- •Refusal by those with parental authority
- •Patient not affiliated with social security
- •Patient receiving AME (Medical Aid for Life)
- •Contraindication or impossibility of performing static respiratory mechanics measurements: pneumothorax or pleural leak, head trauma or threatening HTIC, unstable patient with SpO2 \< 88%, patient receiving nitric oxide (NO) (circuit leaks) or other circuit leaks or patient leaks \> 20% displayed on the ventilator
研究组 & 干预措施
Measurement of airway opening pressure with pediatric slow flow method on first
Measurement of airway opening pressure in invasively ventilated pediatric patients with "pediatric slow flow method" on first and "fixed flow method" in a second time.
干预措施: Measurement of airway opening pressure (Other)
Measurement of airway opening pressure with fixed flow method on first
Measurement of airway opening pressure in invasively ventilated pediatric patients with "fixed flow method" on first and "pediatric slow flow method" in a second time.
干预措施: Measurement of airway opening pressure (Other)
结局指标
主要结局
Feasibility of the two methods of measuring airway opening pressure
时间窗: 5 years
The method will be considered feasible if at least one maneuver out of three allows a measurement of the airway opening pressure to be obtained.
次要结局
- Value of airway opening pressure with each of the two measurement methods(1 day)
- Prevalence of airway opening pressure(5 years)
- Value of Positive end-expiratory pressure settled by the clinican and measured airway opening pressure(1 day)
- Description of the tolerance of the two methods of measuring airway opening pressure(5 years)
- Duration of the methods(5 years)