Single Breath Counting Test for Acute Respiratory Failure in Emergency Department: Multicenter Observational Prospective Trial (STARED-TRIAL)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Single Breath Counting Test (SBCT)
研究概览
简要总结
The purpose of the study is to determine whether SBCT is a useful tool for diagnosing the main form of failure respiratory acute and to define the SBCT limit associated with insufficiency respiratory in this population, the requirement for NIV or invasive ventilation.
Furthermore, the correlation with the most common scores and indices used in the emergency room will be studied, such as: HACOR, MEW, REMS SCORE, ROS, CURB-65, qSOFA, SEVERITY INDEX OF PNEUMONIA, GWTG HF, LUNG ULTRASOUND SCORE, SINGLE BREATH COUNT
详细描述
Single breath counting test (SBCT) is the measurement of how far an individual can count in a normal speaking voice after a maximal effort inspiration. Previous work has demonstrated that SBCT has good correlation with the gold standard measures of pulmonary function test, peak expiratory flow rate and forced expiratory volume in the first second.
The easy of the SBCT makes this test appealing for rapid assessment of respiratory status overall in patients admitted for acute respiratory failure and we hypothesized that it will be valuable, replicable and fast tools for bedside assessment of respiratory function in Emergency Department.
The purpose of the study is to determine whether SBCT is a useful tool for diagnosis of the major form of acute respiratory failure and to define the cut-off limit of SBCT associated to respiratory failure in this population, requirement of NIV or invasive ventilation. Moreover, it will be studied the correlation with the most common scores and indexes used in emergency department like: HACOR, MEW, REMS SCORE, ROS, CURB-65, qSOFA, PNEUMONIA SEVERITY INDEX, GWTG-HF, LUNG ULTRASOUND SCORE, SINGLE BREATH COUNTING TEST
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 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any Acute Respiratory Failure
- •SaO2 <92% on air room at ED admission
排除标准
- •Age < 18 yo
- •Patients already in NIV AND HCFN in ED
- •Home-oxygen or Home-NIV therapy
- •SpO2 < 80%
- •Severe dyspnea
- •unable to speak complete sentences
- •Uncooperative patients
- •Hemodynamic Instability < 90 mmHg or vasopressor requirement at admission
- •ST Elevation-Miocardial Infarction
- •Tracheo -stomized or -tomized patients
- •End of life
结局指标
主要结局
Single Breath Counting Test (SBCT)
时间窗: Change from Baseline at 3 hours
Determine if SBCT is a useful, fast and reproducible tool for assessing respiratory failure and its severity in the Emergency Department.
次要结局
- Correlation with the main critical illness scores(Change from Baseline at 3 hours)
- Cut-off limit to initiate appropriate respiratory support(Change from Baseline at 3 hours)
- Correlation with Emergency Room Mortality(Change from Baseline at 3 hours)
- SBCT as predictor NIRS(Change from Baseline at 3 hours)
- Correlation with imaging(Change from Baseline at 3 hours)
- Correlation with the main serum markers(Change from Baseline at 3 hours)
- Correlation between pulmonary and extrapulmonary causes(Change from Baseline at 3 hours)
- Cut-off limit of SBCT(Change from Baseline at 3 hours)