Single Breath Counting Test for Acute Respiratory Failure in Emergency Department
- Conditions
- Acute Respiratory Failure
- Interventions
- Procedure: Oxygen TherapyProcedure: Non-Invasive Ventilation (NIV)Procedure: Invasive Ventilation
- Registration Number
- NCT06257784
- Lead Sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
- Brief Summary
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
- Detailed Description
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
- Any Acute Respiratory Failure
- SaO2 <92% on air room at ED admission
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Acute Respiratory Failure Non-Invasive Ventilation (NIV) Every patient admitted in Emergency department with any acute respiratory failure will be screened according to inclusion and exclusion criteria to being recruited in the study Acute Respiratory Failure Oxygen Therapy Every patient admitted in Emergency department with any acute respiratory failure will be screened according to inclusion and exclusion criteria to being recruited in the study Acute Respiratory Failure Invasive Ventilation Every patient admitted in Emergency department with any acute respiratory failure will be screened according to inclusion and exclusion criteria to being recruited in the study
- Primary Outcome Measures
Name Time Method Single Breath Counting Test (SBCT) 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.
- Secondary Outcome Measures
Name Time Method Correlation with the main critical illness scores Change from Baseline at 3 hours Define the correlation of SBCT with the main critical illness scores
Cut-off limit to initiate appropriate respiratory support Change from Baseline at 3 hours Define the cut-off limit to initiate appropriate respiratory support
Correlation with Emergency Room Mortality Change from Baseline at 3 hours Define the correlation of SBCT with Emergency Room Mortality
SBCT as predictor NIRS Change from Baseline at 3 hours Define if Single Breath Counting Test (SBCT) could be a predictor of Non-Invasive Respiratory Strategies (NIRS)
Correlation with imaging Change from Baseline at 3 hours Define the correlation of SBCT with radiographic (infiltrated) and ultrasound imaging
Correlation with the main serum markers Change from Baseline at 3 hours Define the correlation of SBCT with the main serum markers corresponding to the underlying respiratory failure disorder
Correlation between pulmonary and extrapulmonary causes Change from Baseline at 3 hours Correlation between pulmonary and extrapulmonary causes
Cut-off limit of SBCT Change from Baseline at 3 hours Define the cut-off limit, the sensitivity and the specificity of SBCT associated with respiratory failure
Trial Locations
- Locations (1)
Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo
🇮🇹Alessandria, Piedmont, Italy