NCT06257784

Single Breath Counting Test for Acute Respiratory Failure in Emergency Department

Single Breath Counting Test for Acute Respiratory Failure in Emergency Department: Multicenter Observational Prospective Trial (STARED-TRIAL)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria · Academic / Other
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

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

Conditions

• Acute Respiratory Failure

Interventions

Type	Name	Description
PROCEDURE	Oxygen Therapy	Patients who have SpO2 \< 92% on room air will undergo oxygen therapy (nasal cannula or Venturi-mask).
PROCEDURE	Non-Invasive Ventilation (NIV)	Patients with P/F \< 250 or Ph \< 7,35 with PCO2 \> 50 mmHg will undergo Non-Invasive Ventilation (NIV) (high flow nasal cannula or CPAP).
PROCEDURE	Invasive Ventilation	Patients with P/F \< 150 associated to dyspnea at rest (moderate to severe, shortness of breath and/ or tachypnea (\>24 breaths/min) despite NIV for at least 2 hours or patients with Ph \< 7,2 with PCO2 \> 60 mmHg despite NIV for at least 2 hours will undergo invasive ventilation (intubation).

Timeline

• Start date: 2022-03-30
• Primary completion: 2024-03-30
• Completion: 2024-03-31
• First posted: 2024-02-14
• Last updated: 2024-02-14

Locations

1 site across 1 country: Italy