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临床试验/NCT04791501
NCT04791501Unknown不适用

Prevalence and Outcome of Acute Hypoxemic Respiratory Failure in Children.

Yolanda Lopez Fernandez21 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
21
主要终点
Prevalence of hypoxemic acute respiratory failure.

研究概览

简要总结

The present study is aimed to establish the epidemiological characteristics and clinical outcomes of mechanically ventilated children with acute hypoxemic respiratory failure (AHRF), defined as PaO2/FiO2 ≤300 mmHg on PEEP≥5 cmH2O and FiO2≥0.3, admitted in a network of pediatric hospitals in Spain.

详细描述

Prospective, multicenter, observational study focused on the prevalence and outcomes of Acute Hypoxemic Respiratory Failure in children. From a total of 40 pediatric ICUs in Spain, 22 PICUs agreed to participate.

All consecutive patients from 7 days to 16 years old admitted in the PICU will have been enrolled if they fulfilled the following criteria: 1) acute episode (within 7 days of a clinical insult), 2) on invasive mechanical ventilatory support, 3) PaO2/FiO2 ≤ 300 mmHg (or SpO2/FiO2 ≤ 264), 4) Positive end-expiratory pressure (PEEP) ≥ 5 cmH2O and FiO2 ≥ 0.3.

This study is considered an audit, and informed consent is waived.

Period of study: 2 years (October 2019 to September 2021). Recruitment period: two consecutive months (i.e October-November followed by a period of no recruitment) until complete 12 months of recruitment (September 2021).

All investigators have received guidelines outlining the study design and the methods for data collection. All PICU admissions are screened daily for AHRF. Onset of AHRF was defined as the day on which the patient first met all inclusion criteria. All data are collected on standardized forms. Demographics, comorbidities, reason for initiation of IMV, arterial blood gases, laboratory, radiographic, hemodynamic and ventilator data were collected at study entry and during the first three days of AHRF diagnosis (T0 or time of inclusion in the study, 24 hours, days 2 and 3). Chest imaging (chest radiographs, lung ultrasound or computed tomography) were evaluated daily for the presence or absence of infiltrates, atelectasis, acute pulmonary edema, pleural effusion or pneumothorax. Tidal volume (VT) was calculated on the basis of the predicted body weight (PBW). Plateau pressure (Pplat) was determined after the application of a 0.5- to 1.0-sec end-inspiratory hold. Driving pressure was calculated as the difference between Pplat and PEEP. Patients meeting pediatric ARDS criteria were stratified into a mild, moderate, and severe according to PALICC definition and/or berlin definition. All patients are followed until PICU and hospital discharge.

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
7 Days 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients from 7 days to 16 years old admitted in the PICU.
  • Acute episode (within 7 days of a clinical insult)
  • On invasive mechanical ventilatory support
  • PaO2/FiO2 ≤ 300 mmHg (or SpO2/FiO2 ≤ 264)
  • Positive end-expiratory pressure (PEEP) ≥ 5 cmH2O and FiO2 ≥ 0.3.

排除标准

  • Non-invasive respiratory support *Aged >16 years or < 7 days.

结局指标

主要结局

Prevalence of hypoxemic acute respiratory failure.

时间窗: 12 months

The investigators will calculate the prevalence in relation to: (i) total number of ICU admissions during the study period in all participating centers; (ii) total number of mechanically ventilated patients during the study period in all participating centers, and (iii) per ICU bed available in the participating centers over the study period.

次要结局

  • Death in the ICU and in the hospital(through study completion, an average of 60 days)

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yolanda Lopez Fernandez

Principal Investigator

Hospital de Cruces

研究点 (21)

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