Single Breath Counting Test for Acute Respiratory Failure in Emergency Department

Last updated: February 5, 2024
Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Injury

Acute Respiratory Distress Syndrome (Ards)

Respiratory Failure

Treatment

Invasive Ventilation

Oxygen Therapy

Non-Invasive Ventilation (NIV)

Clinical Study ID

NCT06257784
ASO.RianGen.22.01
  • Ages 18-110
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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

Study Design

Total Participants: 600
Treatment Group(s): 3
Primary Treatment: Invasive Ventilation
Phase:
Study Start date:
March 30, 2022
Estimated Completion Date:
March 31, 2024

Study 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

Connect with a study center

  • Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo

    Alessandria, Piedmont 15121
    Italy

    Active - Recruiting

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