Evaluation of Altitude as an Independent Risk Factor for Mortality in Pediatric Acute Respiratory Distress Syndrome: Influence of Oxygenation, Ventilation, and Hospital Structure in a Multicenter Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,600
- 试验地点
- 24
- 主要终点
- In-hospital mortality
研究概览
简要总结
This multicenter observational study will evaluate the association between geographic altitude, availability of critical care resources, and clinical outcomes in children with pediatric acute respiratory distress syndrome (PARDS). Data on demographics, physiology, and hospital structure will be collected from PICUs located at different altitudes worldwide. The study aims to identify gaps in PARDS management and provide recommendations adapted to diverse resource settings.
详细描述
Pediatric acute respiratory distress syndrome (PARDS) is a major cause of admission and mortality in pediatric intensive care units (PICUs). In high-altitude regions, hypoxemia may be exacerbated, complicating diagnostic interpretation and clinical decision-making. At the same time, variability in the availability of advanced resources-such as mechanical ventilation modes, monitoring systems, and trained personnel-could significantly influence outcomes.
This study will prospectively and retrospectively collect clinical, physiological, and institutional data from pediatric cohorts admitted to PICUs situated at different altitudes worldwide. The analysis will explore how altitude and structural resource differences interact with oxygenation and ventilation parameters to affect patient outcomes. The ultimate goal is to generate evidence that supports context-specific guidelines, reduces inequities in critical care delivery, and strengthens pediatric intensive care practices globally.
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
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 1 month (corrected gestational age) and 18 years.
- •Admission to a pediatric intensive care unit (PICU) or facility where mechanically ventilated children are cared for.
- •Requirement of invasive mechanical ventilation.
- •Diagnosis of pediatric acute respiratory distress syndrome (PARDS) according to PALICC criteria, confirmed within 24 hours before or after endotracheal intubation.
排除标准
- •Patients with active perinatal lung disease (e.g., neonatal respiratory distress syndrome, pulmonary hemorrhage, persistent pulmonary hypertension of the newborn, early bronchopulmonary dysplasia, meconium aspiration).
- •Patients who have received extracorporeal membrane oxygenation (ECMO) prior to or within the first 24 hours of PARDS diagnosis.
- •Patients with pre-established limitation of therapeutic effort (LTE) orders or palliative care directives documented before the initiation of invasive mechanical ventilation.
- •Readmissions to the PICU during the study period (only the first episode per patient will be included).
研究组 & 干预措施
Low Altitude PICUs
Children with PARDS admitted to pediatric intensive care units located at altitudes between 0-1500 meters above sea level.
干预措施: Geographic Altitude (Other)
Intermediate Altitude PICUs
Children with PARDS admitted to pediatric intensive care units located at altitudes between 1501-2500 meters above sea level.
干预措施: Geographic Altitude (Other)
High Altitude PICUs
Children with PARDS admitted to pediatric intensive care units located at altitudes between 2501-3500 meters above sea level.
干预措施: Geographic Altitude (Other)
Very High Altitude PICUs
Children with PARDS admitted to pediatric intensive care units located at altitudes above 3500 meters above sea level.
干预措施: Geographic Altitude (Other)
结局指标
主要结局
In-hospital mortality
时间窗: From PICU admission until hospital discharge (up to 90 days)
Proportion of patients with PARDS who die during hospitalization. Mortality is defined as death during the same hospitalization period in which PARDS was diagnosed.
次要结局
- New morbidity at hospital discharge(From PICU admission until hospital discharge (up to 90 days))
- Ventilator-free days at 28 days.(28 days after initiation of invasive mechanical ventilation)
- ICU-free days at 28 days.(28 days after ICU admission)