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

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

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

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Failure
• Intervention / Treatment: Procedure: Oxygen Therapy; Procedure: Non-Invasive Ventilation (NIV); Procedure: Invasive Ventilation

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

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Clinical Trial Center; Phone Number: +39 0131206893; Email: clinicaltrialcenter@ospedale.al.it

Study Locations

• Italy
  • Piedmont
    • Alessandria, Piedmont, Italy, 15121
      • Recruiting
      • Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo
      • Contact: Clinical Trial Center; Phone Number: +39 0131206893; Email: clinicaltrialcenter@ospedale.al.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with any Acute Respiratory Failure admitted in Emergency department

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Acute Respiratory Failure; 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

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Correlation with the main critical illness scores	Define the correlation of SBCT with the main critical illness scores	Change from Baseline at 3 hours
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
Correlation with imaging	Define the correlation of SBCT with radiographic (infiltrated) and ultrasound imaging	Change from Baseline at 3 hours
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
Cut-off limit to initiate appropriate respiratory support	Define the cut-off limit to initiate appropriate respiratory support	Change from Baseline at 3 hours
Correlation with Emergency Room Mortality	Define the correlation of SBCT with Emergency Room Mortality	Change from Baseline at 3 hours
Correlation between pulmonary and extrapulmonary causes	Correlation between pulmonary and extrapulmonary causes	Change from Baseline at 3 hours

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
• Investigators: Principal Investigator: Yaroslava Longhitano, Physician, Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2022
• Primary Completion (Estimated): March 30, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: May 11, 2023
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Acute Respiratory Failure; Single breath counting test
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease Attributes; Emergencies; Respiratory Insufficiency; Respiratory Distress Syndrome
• Other Study ID Numbers: ASO.RianGen.22.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No