Single Breath Counting Test for Acute Respiratory Failure in Emergency Department (STARED)

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Status: Enrolling

Conditions: Acute Respiratory Failure

Treatments: Procedure: Non-Invasive Ventilation (NIV); Procedure: Oxygen Therapy; Procedure: Invasive Ventilation

Study type: Observational

Funder types: Other

Identifiers

NCT06257784

ASO.RianGen.22.01

Details and patient eligibility

About

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

Full 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

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any Acute Respiratory Failure
• SaO2 <92% on air room at ED admission

Exclusion criteria

• 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

Trial design

600 participants in 1 patient group

Acute Respiratory Failure

Description:

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

Treatment:

Procedure: Invasive Ventilation

Procedure: Oxygen Therapy

Procedure: Non-Invasive Ventilation (NIV)