PREdicting Failure of Non-inVasIve Ventilatory Support Using Non-invaSIve mONitoring in Non-intubated Patients With Acute Hypoxemic Respiratory Failure or Post-extubation Failure. The PREVISION Study

NCT06716463 | Recruiting

• 1 other identifier: Unity Health Toronto
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to assess the potential non-invasive tools (e.g. regional ventilation, respiratory muscle response, lung mechanic's parameters) to identify the risk of failure when using high flow nasal cannula (HFNC) or non-invasive ventilation (NIV). The main question, it aims to answer is: Does abnormal regional ventilation could predict HFNC or NIV failure?

Conditions

Ventilatory Failure; Hypoxemic Respiratory Failure; Weaning Failure; Respiratory

Keywords

Electrical impedance tomography; High flow nasal cannula; Non-invasive ventilation; Diaphragm; Weaning failure; Post-extubation; Hypoxemic respiratory failure

Outcome Measures

Primary Outcomes (1)

• Difference in regional ventilation distribution (%)

  The primary endpoint is to assess regional ventilation distribution (%) when using HFNC or NIV to predict a device failure.

  The parameter is measured at the time of enrolment. Failure of HFNC or NIV is adjudicated at 7 days.

Secondary Outcomes (7)

• Diaphragm or parasternal intercostal muscle thickening fraction

  The parameter is measured at the time of enrolment. Failure of HFNC or NIV is adjudicated at 7 days.

• Rapid shallow breathing index (RSBI) in mL/breaths/min

  The parameter is measured at the time of enrolment. Failure of HFNC or NIV is adjudicated at 7 days.

• Respiratory drive using negative airway pressure generated during the first 100 millisecond (P0.1)

  The parameter is measured at the time of enrolment. Failure of HFNC or NIV is adjudicated at 7 days.

• Respiratory effort using end-expiratory airway occlusion pressure (ΔPocc)

  The parameter is measured at the time of enrolment. Failure of HFNC or NIV is adjudicated at 7 days.

• The intensive care respiratory distress observation scale (IC-RDOS)

  The parameter is measured at the time of enrolment. Failure of HFNC or NIV is adjudicated at 7 days.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient who is using high flow nasal cannula (HFNC) or non-invasive ventilation (NIV) to either prevent 1. intubation in the context of acute hypoxemic respiratory failure or 2. reintubation in the context of high risk group of extubation.

You may qualify if:

• Age of ≥ 18 years
• Using NIV or HFNC anywhere in the hospital

You may not qualify if:

• Chronic CO2 retention
• Neuromuscular disorder
• Requiring home NIV (CPAP or BIPAP)
• Tracheostomy
• Contraindication to EIT placement: pacemaker/defibrillator implantation, burns at the area of EIT placement

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

MeSH Terms

Conditions

Hypoventilation; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 4, 2024
• Study Start: January 27, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)