Single Breath Counting Test for Acute Respiratory Failure in Emergency Department

Acute Respiratory Failure Clinical Trial

— STARED  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06257784
• Other study ID #: ASO.RianGen.22.01
• Status: Recruiting
• Start date: March 30, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: March 2023
• Source: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
• Contact: Clinical Trial Center
• Phone: 0131206893
• Email: clinicaltrialcenter[@]ospedale.al.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: March 31, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Emergencies
• Respiratory Distress Syndrome
• Respiratory Insufficiency

Intervention

Procedure:
• Oxygen Therapy
Patients who have SpO2 < 92% on room air will undergo oxygen therapy (nasal cannula or Venturi-mask).
• 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).
• 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).

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo	Alessandria	Piedmont

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Single Breath Counting Test (SBCT)	Determine if SBCT is a useful, fast and reproducible tool for assessing respiratory failure and its severity in the Emergency Department.	Change from Baseline at 3 hours
Secondary	SBCT as predictor NIRS	Define if Single Breath Counting Test (SBCT) could be a predictor of Non-Invasive Respiratory Strategies (NIRS)	Change from Baseline at 3 hours
Secondary	Correlation with the main critical illness scores	Define the correlation of SBCT with the main critical illness scores	Change from Baseline at 3 hours
Secondary	Correlation with the main serum markers	Define the correlation of SBCT with the main serum markers corresponding to the underlying respiratory failure disorder	Change from Baseline at 3 hours
Secondary	Correlation with imaging	Define the correlation of SBCT with radiographic (infiltrated) and ultrasound imaging	Change from Baseline at 3 hours
Secondary	Cut-off limit of SBCT	Define the cut-off limit, the sensitivity and the specificity of SBCT associated with respiratory failure	Change from Baseline at 3 hours
Secondary	Cut-off limit to initiate appropriate respiratory support	Define the cut-off limit to initiate appropriate respiratory support	Change from Baseline at 3 hours
Secondary	Correlation with Emergency Room Mortality	Define the correlation of SBCT with Emergency Room Mortality	Change from Baseline at 3 hours
Secondary	Correlation between pulmonary and extrapulmonary causes	Correlation between pulmonary and extrapulmonary causes	Change from Baseline at 3 hours