Epidemiologic Multicenter Study on Mechanical Ventilation Management in Children With Acute Lung Injury - Phase 1 PALIVE 1 (for Pediatric Acute Lung Injury Mechanical VEntilation Strategies)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 57
研究概览
简要总结
PALIVE 1 is an observational multicenter study on mechanical ventilation strategies used in children with an acute lung injury (ALI). The objective of the study is to describe mechanical ventilation strategies in children with an ALI. Our hypothesis is that daily clinical practice is heterogenous among pediatric intensivists as few pediatric data exists on optimal mechanical ventilation strategies in this group of patients. Furthermore, different strategies may affect patient outcome.
详细描述
INTRODUCTION Few pediatric data exists on the ventilation mode and parameters that would provide the greatest benefit with the least risk to an individual pediatric patient with Acute Lung Injury (ALI). Current expert opinion is that it is reasonable to follow adult recommendations and to adapt clinical management in children according to adult data. In the absence of consensus and established guidelines for mechanical ventilation in children with ALI, we believe that the daily clinical practice in pediatric intensive care units is subject to great variations according to the experience, comfort and knowledge of the attending intensivist.
METHODS Objective: Describe invasive and non-invasive mechanical ventilation in pediatric cases of ALI.
Hypothesis: There is an important variability in the observed practice pattern of mechanical ventilation in pediatric cases of ALI.
Design: An international cross-sectional epidemiologic study in Pediatric Intensive Care Units on the observed practice pattern of invasive and non-invasive mechanical ventilation in children with ALI.
Setting: Pediatric Intensive Care Units in Canada, United States, Europe.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child on invasive mechanical ventilation administered through an endotracheal tube or a tracheostomy tube, or on non-invasive mechanical ventilation administered through a nasal or facial mask or a nasal canula or helmet at 9 a.m. on the day of the study.
- •Presence of ALI as estimated by the attending physician:
- •Onset of hypoxemia was acute
- •Bilateral infiltrates on chest X-Ray
- •No clinical evidence of congestive heart failure
- •Sustained hypoxemia defined as:
- •PaO2(mmHg)/FiO2 ratio ≤ 300 or PaO2(kPa)/FiO2 ≤ 40
- •If no arterial canula or no arterial blood gas:
- •SpO2/FiO2 ≤ 320 with SpO2 < 0.98 (10)
排除标准
- •Post conceptional age < 42 weeks
- •Age > 18 years
- •Non-corrected cyanotic congenital heart disease or evidence of extra-pulmonary right to left shunt
- •Withdrawal/withholding of care
- •Brain death
- •No consent, if required
- •Patient on ECMO
- •Already included in this study