Clinical trial NCT06257784: Single Breath Counting Test for Acute Respiratory Failure in Emergency Department
Official title: Single Breath Counting Test for Acute Respiratory Failure in Emergency Department: Multicenter Observational Prospective Trial (STARED-TRIAL)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Respiratory Failure
Keywords: Single breath counting test
Acute Respiratory Failure
Lead sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with any Acute Respiratory Failure admitted in Emergency department

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

Eligibility criteria: 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

Primary outcomes:
measure: Single Breath Counting Test (SBCT)
timeFrame: Change from Baseline at 3 hours
Secondary outcomes:
measure: SBCT as predictor NIRS
timeFrame: Change from Baseline at 3 hours
measure: Correlation with the main critical illness scores
timeFrame: Change from Baseline at 3 hours
measure: Correlation with the main serum markers
timeFrame: Change from Baseline at 3 hours
measure: Correlation with imaging
timeFrame: Change from Baseline at 3 hours
measure: Cut-off limit of SBCT
timeFrame: Change from Baseline at 3 hours
measure: Cut-off limit to initiate appropriate respiratory support
timeFrame: Change from Baseline at 3 hours
measure: Correlation with Emergency Room Mortality
timeFrame: Change from Baseline at 3 hours
measure: Correlation between pulmonary and extrapulmonary causes
timeFrame: Change from Baseline at 3 hours
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo
state: Piedmont
Study officials:
affiliation: Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo
name: Yaroslava Longhitano, Physician
role: PRINCIPAL_INVESTIGATOR
References: