Acute Respiratory FailureSTAREDNCT06257784
Single Breath Counting Test for Acute Respiratory Failure in Emergency Department
An observational study of Acute Respiratory Failure, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- Oxygen Therapy, Non-Invasive Ventilation (NIV) and Invasive Ventilation
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 30 Mar 2022to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with any Acute Respiratory Failure admitted in Emergency department
Who may be able to join
- Any Acute Respiratory Failure
- SaO2 <92% on air room at ED admission
Who cannot join
- 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
Show all 11Show fewer
- Uncooperative patients
- Hemodynamic Instability < 90 mmHg or vasopressor requirement at admission
- ST Elevation-Miocardial Infarction
- Tracheo -stomized or -tomized patients
- End of life
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo
Alessandria, Piedmont, 15121
Clinical Trial Center, 0131206893 ext. +39, clinicaltrialcenter@ospedale.al.it
About this study
Official title: 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
Read the 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
- Being tested
- Oxygen Therapy, Non-Invasive Ventilation (NIV), Invasive Ventilation
- Keywords
- Single breath counting test, Acute Respiratory Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen TherapyProcedure or surgery
Patients who have SpO2 < 92% on room air will undergo oxygen therapy (nasal cannula or Venturi-mask).
Non-Invasive Ventilation (NIV)Procedure or surgery
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 VentilationProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Oxygen Therapy; Procedure: Non-Invasive Ventilation (NIV); Procedure: Invasive Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline at 3 hours
Secondary outcomes (8)
SBCT as predictor NIRS
Define if Single Breath Counting Test (SBCT) could be a predictor of Non-Invasive Respiratory Strategies (NIRS)
Measured: Change from Baseline at 3 hours
Correlation with the main critical illness scores
Define the correlation of SBCT with the main critical illness scores
Measured: 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
Measured: Change from Baseline at 3 hours
Correlation with imaging
Define the correlation of SBCT with radiographic (infiltrated) and ultrasound imaging
Measured: 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
Measured: Change from Baseline at 3 hours
Cut-off limit to initiate appropriate respiratory support
Define the cut-off limit to initiate appropriate respiratory support
Measured: Change from Baseline at 3 hours
Correlation with Emergency Room Mortality
Define the correlation of SBCT with Emergency Room Mortality
Measured: Change from Baseline at 3 hours
Correlation between pulmonary and extrapulmonary causes
Correlation between pulmonary and extrapulmonary causes
Measured: Change from Baseline at 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start30 Mar 2022
- Primary completion30 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yaroslava Longhitano, Physician, Principal investigator, Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257784
- Sponsor's protocol ID
- ASO.RianGen.22.01
- Acronym
- STARED
- Status last verified
- Mar 2023
- First submitted
- 11 May 2023
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Breath Counting Test for Acute Respiratory Failure in Emergency Department: Multicenter Observational Prospective Trial (STARED-TRIAL)
- ClinicalTrials.gov ID
- NCT06257784
- Acronym / sponsor ID
- STARED / ASO.RianGen.22.01
- Conditions
- Acute Respiratory Failure
- Keywords
- Single breath counting test, Acute Respiratory Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di AlessandriaUniversity, hospital or other
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Respiratory Failure | – | Procedure: Oxygen Therapy, Procedure: Non-Invasive Ventilation (NIV), Procedure: Invasive VentilationEvery 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 |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with any Acute Respiratory Failure admitted in Emergency department
Key inclusion criteria (2 listed)
- Any Acute Respiratory Failure
- SaO2 <92% on air room at ED admission
Key exclusion criteria (11 listed)
- Age < 18 yo
- Patients already in NIV AND HCFN in ED
- Home-oxygen or Home-NIV therapy
- SpO2 < 80%
- Severe dyspnea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen TherapyPatients who have SpO2 < 92% on room air will undergo oxygen therapy (nasal cannula or Venturi-mask). | Procedure or surgery | Acute Respiratory Failure |
| 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 or surgery | Acute Respiratory Failure |
| Invasive VentilationPatients 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). | Procedure or surgery | Acute Respiratory Failure |
Primary outcome
Single Breath Counting Test (SBCT)
Time frame: Change from Baseline at 3 hours
Determine if SBCT is a useful, fast and reproducible tool for assessing respiratory failure and its severity in the Emergency Department.
8 secondary outcomes
SBCT as predictor NIRS
Time frame: Change from Baseline at 3 hours
Correlation with the main critical illness scores
Time frame: Change from Baseline at 3 hours
Correlation with the main serum markers
Time frame: Change from Baseline at 3 hours
Correlation with imaging
Time frame: Change from Baseline at 3 hours
Cut-off limit of SBCT
Time frame: Change from Baseline at 3 hours
Cut-off limit to initiate appropriate respiratory support
Time frame: Change from Baseline at 3 hours
Correlation with Emergency Room Mortality
Time frame: Change from Baseline at 3 hours
Correlation between pulmonary and extrapulmonary causes
Time frame: Change from Baseline at 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaroslava Longhitano, Physician principal investigator
Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Center (0131206893 ext. +39, clinicaltrialcenter@ospedale.al.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single Breath Counting Test (SBCT) (time frame: Change from Baseline at 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.