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临床试验/NCT03415529
NCT03415529已完成不适用

Incidence of Hypercapnia and Impact of Arterial CO2 Tension on Management and Outcome in Patients With Acute Respiratory Distress Syndrome (ARDS)

European Society of Intensive Care Medicine1 个研究点 分布在 1 个国家目标入组 4,500 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4,500
试验地点
1
主要终点
Incidence

研究概览

简要总结

There appears to be considerable variability in the approach physicians use to manage arterial carbon dioxide tensions, in patients in the early phases [first 48 hours] of ARDS (Acute hypoxemic respiratory failure and). A number of specific concerns exist, particularly the use of greater than needed inspired oxygen concentrations (potentially in 40% patients), and the proportion of hypocapnic patients in our cohort.

详细描述

This study will address a number of specific concerns, including:

  1. the incidence of hypocapnia and hypercapnia;
  2. the factors (e.g. ventilatory mode) contributing to hypocapnia and hypercapnia;
  3. the impact of hypocapnia and hypercapnia on progression of ARDS, duration of ventilation, ICU stay, hospital stay and patient outcome;
  4. the impact of pH (respiratory versus metabolic cause) on outcome variables.

LUNG SAFE was a prospective observational study. There was not patient intervention. The current analysis is a secondary analysis of this existing database.

Data will be abstracted form the database on all patients meeting the inclusion criteria for ARDS (during the first 2 days from AHRF onset) for the following variables: Patient's demographic characteristics (age, sex) and chronic comorbidities, Arterial PCO2, pH in first 48 hours, Data on P/F ratio over course of illness, Duration of ventilation, ICU stay, hospital survival in patients identified as being exposed to hypocapnia (pCO2 < or = to 30mmHg) and hypercapnia (PCO2 > or = to 45mmHg); Main ventilatory variables: mode of ventilation, tidal volume, respiratory.

Descriptive statistics will include proportions for categorical and mean (standard deviation) or median (interquartile range) for continuous variables, according the data distribution. The amount of missing data in the LUNG SAFE database is low so no assumptions will be made for missing data.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients meeting criteria for ARDS. Fulfillment of criteria for Acute Hypoxaemic respiratory failure (AHRF) and fulfillment of Berlin criteria for ARDS during the first two days after AHRF onset.

排除标准

  • Age < 18

结局指标

主要结局

Incidence

时间窗: LUNG SAFE was a prospective observational study. Patients were followed until hospital discharge or day 90, whichever came first

The incidence of hypercapnia \[i.e. PaCO2 \> 45 mmHg\] when ARDS arises

次要结局

  • Hypercapnia(LUNG SAFE was a prospective observational study. Patients were followed until hospital discharge or day 90, whichever came first)
  • Severity(LUNG SAFE was a prospective observational study. Patients were followed until hospital discharge or day 90, whichever came first)
  • pH ((potential of hydrogen)(LUNG SAFE was a prospective observational study. Patients were followed until hospital discharge or day 90, whichever came first)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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