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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUnity Health Toronto

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age of ≥ 18 years

Using NIV or HFNC anywhere in the hospital

Disqualifiers

Chronic CO2 retention

Neuromuscular disorder

Requiring home NIV (CPAP or BIPAP)

Tracheostomy

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

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

Secondary outcomes

1

Diaphragm or parasternal intercostal muscle thickening fraction

To assess ultrasound measurement of inspiratory muscle activity when using HFNC or NIV to predict a device failure.

Time frame
The parameter is measured at the time of enrolment. Failure of HFNC or NIV is adjudicated at 7 days.
2

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

To assess non-invasive respiratory - rapid shallow breathing index (RSBI) derived from NIV to predict a device failure.

Time frame
The parameter is measured at the time of enrolment. Failure of HFNC or NIV is adjudicated at 7 days.
3

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

To assess respiratory drive - using negative airway pressure generated during the first 100 millisecond (P0.1) in cmH2O to predict device failure.

Time frame
The parameter is measured at the time of enrolment. Failure of HFNC or NIV is adjudicated at 7 days.
4

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

To assess respiratory effort using end-expiratory airway occlusion pressure (ΔPocc) in cmH2O to predict device failure

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.