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The Relationship Between Positive End Expiratory Pressure and Cardiac Index in Patients With Acute Respiratory Distress Syndrome (ARDS) Managed on a Fluid Protocol

2012年10月25日更新者：Yale University

The Relationship Between Positive End Expiratory Pressure and Cardiac Index in Patients With ARDS Managed on a Fluid Protocol: A Secondary Analysis of a Prospective Trial

The objective of this study is to evaluate the association between positive end-expiratory pressure (PEEP) setting and cardiac function, as measured by cardiac index, in patients with acute respiratory distress syndrome (ARDS) who were managed on the NHLBI ARDS Network Fluid and Catheter Treatment Trial (FACTT) fluid protocols.

研究概览

地位

完全的

条件

急性呼吸窘迫综合征 (ARDS)

详细说明

This is a secondary cross-sectional analysis of the FACTT multi-center randomized controlled trial enrolling adult patients within 48 hours of ARDS onset from twenty medical centers across the US, some of which included more than one hospital. We studied the patients who were randomized to the pulmonary artery catheter arm of the FACTT study. The investigators included patients that had PEEP and cardiac index measurements performed within a short period of each other during the first 3 days of the FACTT study enrollment. Since FACTT had a 2x2 factorial design, half of the patients were in a 'liberal fluids' study arm, and the other half were in a 'conservative fluids' study arm.

研究类型

观察性的

注册 (实际的)

367

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

美国
- Connecticut
  - New Haven、Connecticut、美国、06510
    - Yale University, School of Medicine, Department of Internal Medicine, Section of Pulmonary and Critical Care Medicine

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

This is a secondary cross-sectional analysis of the FACTT multi-center randomized controlled trial enrolling adult patients within 48 hours of ARDS onset from twenty medical centers across the US, some of which included more than one hospital. We studied the patients who were randomized to the pulmonary artery catheter arm of the FACTT study. We included patients that had PEEP and cardiac index measurements performed within a short period of each other during the first 3 days of the FACTT study enrollment.

描述

Inclusion Criteria:

Acute lung injury diagnosis (as defined by The American - European Consensus Conference on ARDS) of < 48 hours in duration.

Patients in the Pulmonary Artery catheter (PAC) arm of the FACTT study. PaO2 / FiO2 ratio of < 200. Data from the first 3 days of mechanical ventilation.

Exclusion Criteria:

Select chronic conditions that could independently influence survival (e.g., expected 6-month survival < 50%) and / or ventilator weaning.

PEEP values missing. FiO2 values missing. PaO2 values missing. Cardiac index values missing Pressors and / or inotropes requirement.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
High PEEP Cohort of participants with positive end-expiratory pressure (PEEP) greater than or equal to 12cm.
Low PEEP Cohort of participants with positive end-expiratory pressure (PEEP) less than 12cm.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Cardiac Index 大体时间：Cross sectional (i.e. at time Zero only)	The cardiac index is a cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index. The cardiac index which is the outcome measure is assessed at the same time as the PEEP (which is the independent variable) is measured. The study participants are NOT followed for any period of time. This is a cross-sectional study design. Both variables (Cardiac index and PEEP) are measured at the same time.	Cross sectional (i.e. at time Zero only)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Yale University

合作者

University of North Carolina, Chapel Hill

调查人员

首席研究员：Wassim H Fares, MD MSc、Yale University, School of Medicine, Department of Internal Medicine, Section of Pulmonary and Critical Care Medicine

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

Fares WH, Carson SS; NIH NHLBI ARDS Network. The relationship between positive end-expiratory pressure and cardiac index in patients with acute respiratory distress syndrome. J Crit Care. 2013 Dec;28(6):992-7. doi: 10.1016/j.jcrc.2013.06.021. Epub 2013 Aug 28.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年4月1日

初级完成 (实际的)

2012年9月1日

研究完成 (实际的)

2012年9月1日

研究注册日期

首次提交

2012年10月19日

首先提交符合 QC 标准的

2012年10月25日

首次发布 (估计)

2012年10月26日

研究记录更新

最后更新发布 (估计)