Single Breath Counting Test for Acute Respiratory Failure in Emergency Department

NCT ID: NCT06257784

Last Updated: 2024-02-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-30
• Study Completion Date: 2024-03-31

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

Conditions

Acute Respiratory Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Oxygen Therapy

Intervention Type: PROCEDURE

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

Non-Invasive Ventilation (NIV)

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

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).

Interventions

Oxygen Therapy

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

Intervention Type: 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).

Intervention Type: 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).

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yaroslava Longhitano, Physician

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo

Locations

Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo

Alessandria, Piedmont, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Clinical Trial Center

Role: CONTACT

clinicaltrialcenter@ospedale.al.it

0131206893 ext. +39

Facility Contacts

Clinical Trial Center

Role: primary

clinicaltrialcenter@ospedale.al.it

0131206893 ext. +39

Other Identifiers

ASO.RianGen.22.01

Identifier Type: -

Identifier Source: org_study_id