NCT06257784

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2023

Completed
9 months until next milestone

First Posted

Study publicly available on registry

February 14, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

February 14, 2024

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

May 11, 2023

Last Update Submit

February 5, 2024

Conditions

Acute Respiratory Failure

Keywords

Single breath counting testAcute Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • SBCT as predictor NIRS

    Change from Baseline at 3 hours

  • Correlation with the main critical illness scores

    Change from Baseline at 3 hours

  • Correlation with the main serum markers

    Change from Baseline at 3 hours

  • Correlation with imaging

    Change from Baseline at 3 hours

  • Cut-off limit of SBCT

    Change from Baseline at 3 hours

  • +3 more secondary outcomes

Study Arms (1)

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 TherapyProcedure: Non-Invasive Ventilation (NIV)Procedure: Invasive Ventilation

Interventions

Oxygen TherapyPROCEDURE

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

Acute Respiratory Failure
Non-Invasive Ventilation (NIV)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).

Acute Respiratory Failure
Invasive VentilationPROCEDURE

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).

Acute Respiratory Failure

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with any Acute Respiratory Failure admitted in Emergency department

You may qualify if:

  • Any Acute Respiratory Failure
  • SaO2 \<92% on air room at ED admission

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo

Alessandria, Piedmont, 15121, Italy

RECRUITING

MeSH Terms

Interventions

OxygenNoninvasive Ventilation

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGasesRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Yaroslava Longhitano, Physician

    Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trial Center

CONTACT

0131206893clinicaltrialcenter@ospedale.al.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2023

First Posted

February 14, 2024

Study Start

March 30, 2022

Primary Completion

March 30, 2024

Study Completion

March 31, 2024

Last Updated

February 14, 2024

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)