A Multicenter Prospective Cohort Study of Hospital-wide Incidence, Clinical Characteristics and Outcomes of ARDS - The NITWA ARDS Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 9,999
- 试验地点
- 4
- 主要终点
- Hospital-wide incidence of ARDS
研究概览
简要总结
The Acute Respiratory Distress Syndrome (ARDS) impacts one of every four patients requiring mechanical ventilation for respiratory support and carries a mortality rate of 40%. To diagnose ARDS, doctors currently use the Berlin definition, that requires chest radiographs and analysis of oxygenation in the blood (arterial blood gas). These tests are not available in areas of the world with constrained resources and may be unnecessarily invasive. A modification of the Berlin definition, using ultrasound and pulse oximetry (a small device that measures oxygen level non-invasively by clipping to the body, typically a finger), has been recently developed and tested in Kigali, Rwanda.
This study will try to confirm the validity of the Kigali modification initially in Boston and Toronto and subsequently in other hospitals worldwide. If confirmed, this new definition could allow for faster recognition and potentially improved treatment of patients with ARDS and facilitate studies worldwide.
The purposes of this study are:
- To describe clinical characteristics and outcomes of patients diagnosed with ARDS according to the Berlin and Kigali definitions;
- To determine how well chest radiograph and ultrasound of the chest are able to define ARDS, in comparison to chest computer tomography (CT).
详细描述
We hypothesize that the hospital-wide incidence of ARDS, as defined by the Kigali modification, is similar in high resource settings (e.g., Boston and Toronto) as compared to the resource-constrained setting of Kigali, Rwanda. We also hypothesize that pulmonary ultrasound is a more sensitive and similarly specific imaging modality for bilateral opacities than chest radiograph, when compared to the reference standard of chest tomography.
We will test these hypotheses in a multicenter prospective cohort study with the following specific aims:
Aim 1: A) To estimate the hospital-wide incidence of ARDS defined according to both the Berlin definition and the Kigali modification, and B) To describe clinical characteristics and outcomes for these patients.
Aim 2: For the subset of patients who have chest CT, to determine the sensitivity and specificity for bilateral opacities of both chest radiographs and chest ultrasound done within 12 hours as compared to the reference standard CT scans.
As a part of the research study, we will perform a pilot study with the specific aim of assessing feasibility of a multicenter study. Criteria that will be used to assess feasibility include:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospital admission during the study period
- •Age ≥ 18 years old
- •New onset of hypoxemia (SpO2 < 90% or use of any supplemental oxygen) or, for patients on home O2 treatment, higher than baseline O2 flow needed during the first 7 days of hospitalization.
排除标准
- •Patient in the Emergency Department but not formally admitted to the hospital
- •Patient admitted in PACU
结局指标
主要结局
Hospital-wide incidence of ARDS
时间窗: Up to 7 days
ARDS incidence will be calculated as the number of patients fulfilling ARDS (Berlin or Kigali) during the first first 7 days of hospital admission divided by the total adult hospital admissions during the study period.
次要结局
- Sensitivity and specificity for bilateral opacities of both chest radiographs and chest ultrasound done within 12 hours as compared to the reference standard CT scans(Over the first 7 days of admission)
研究者
Alberto Goffi
Assistant Professor
University Health Network, Toronto