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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06257784
Acronym
STARED
Enrollment
600
Registered
2024-02-14
Start date
2022-03-30
Completion date
2024-03-31
Last updated
2024-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure

Keywords

Single breath counting test, Acute Respiratory Failure

Brief 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

Interventions

PROCEDUREOxygen Therapy

Patients who have SpO2 \< 92% on room air will undergo oxygen therapy (nasal cannula or Venturi-mask).

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).

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).

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Single Breath Counting Test (SBCT)Change from Baseline at 3 hoursDetermine if SBCT is a useful, fast and reproducible tool for assessing respiratory failure and its severity in the Emergency Department.

Secondary

MeasureTime frameDescription
Correlation with the main critical illness scoresChange from Baseline at 3 hoursDefine the correlation of SBCT with the main critical illness scores
Correlation with the main serum markersChange from Baseline at 3 hoursDefine the correlation of SBCT with the main serum markers corresponding to the underlying respiratory failure disorder
Correlation with imagingChange from Baseline at 3 hoursDefine the correlation of SBCT with radiographic (infiltrated) and ultrasound imaging
SBCT as predictor NIRSChange from Baseline at 3 hoursDefine if Single Breath Counting Test (SBCT) could be a predictor of Non-Invasive Respiratory Strategies (NIRS)
Cut-off limit to initiate appropriate respiratory supportChange from Baseline at 3 hoursDefine the cut-off limit to initiate appropriate respiratory support
Correlation with Emergency Room MortalityChange from Baseline at 3 hoursDefine the correlation of SBCT with Emergency Room Mortality
Correlation between pulmonary and extrapulmonary causesChange from Baseline at 3 hoursCorrelation between pulmonary and extrapulmonary causes
Cut-off limit of SBCTChange from Baseline at 3 hoursDefine the cut-off limit, the sensitivity and the specificity of SBCT associated with respiratory failure

Countries

Italy

Contacts

Primary ContactClinical Trial Center
clinicaltrialcenter@ospedale.al.it0131206893

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026