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 (PREVISION)

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

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?

Study Overview

• Status: Recruiting
• Conditions: Weaning Failure; Hypoxemic Respiratory Failure; Ventilatory Failure; Respiratory

Detailed Description

This is a single-center, prospective, physiological study.

The study will enroll patient who has used either HFNC or NIV for the indications of 1. to prevent worsening acute hypoxemic respiratory failure or 2. to prevent reintubation. Once being confirmed to meet the inclusion criteria, the research team will apply the electrical impedance tomography (EIT) on the patient and start recording for 5-10 minutes as well as perform diaphragm and parasternal intercostal muscle ultrasound when the patient is using HFNC or NIV. The current HFNC or NIV setting, some lung mechanic's parameters (e.g. rapid shallow breathing trial (RSBI), negative airway pressure generated during the first 100 milisecond (P0.1), end-expiratory occlusion pressure(ΔPocc) derived from NIV machine), patient's characteristic, dyspnea scores (intensive care respiratory distress observation scale, IC-RDOS; work of breathing scale; self-report of dyspnea visual analog scale, D-VAS), ICU and hospital length of stay will be also collected.

The investigator will use EIT to visualize where air goes in the patient's lung and inspiratory muscle ultrasonography (diaphragm and parasternal intercostal muscle) to visualize the muscle activities when using HFNC or NIV. EIT is a measurement often used in the ICU since it allows easy visualization and is a non-invasive technique. The sensors measure electrical current changes during inspiration and expiration and will not cause any pain or radiation concerns. The EIT belt (3-cm diameter) will be placed around the chest without causing adverse event/discomfort/pain.

The duration of study will be approximately 30 minutes. The study will be conducted one time for one enrolled patient.

HFNC or NIV (device) failure is considered as either intubation/reintubation or death, whatever has come first. It will be followed up to 7 days.

The investigators will proceed with the measurements only with agreement from the clinical team. The investigators will analyze the data collected offline with a dedicated software afterwards.

After these study procedures are completed, data will also be collected from the participant's chart and combined with relevant information from the HFNC or NIV settings and vital functions. Confidentiality will be maintained throughout the entire study.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • Recruiting
      • St. Michael's Hospital
      • Contact: Laurent J. Brochard, MD; Phone Number: 5686 416-864-6060; Email: laurent.brochard@unityhealth.to

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	To assess non-invasive respiratory - rapid shallow breathing index (RSBI) derived from 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.
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.	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)	To assess respiratory effort using end-expiratory airway occlusion pressure (ΔPocc) in cmH2O to predict device failure	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)	To assess the level of dyspnea using intensive care respiratory distress observation scale (IC-RDOS) to predict a device failure. There is no minimum or maximum range depending on patient's heart rate, the higher score means worse outcome. When the score ≥ 2.4, it likely indicates clinically important dyspnea requiring clinical management.	The parameter is measured at the time of enrolment. Failure of HFNC or NIV is adjudicated at 7 days.
The work of breathing scale	To assess the work of breathing scale to predict a device failure. Minimum is 3 and maximum is 12, the higher score means worse outcome. When the score > 4, it likely indicates severe respiratory distress.	The parameter is measured at the time of enrolment. Failure of HFNC or NIV is adjudicated at 7 days.
Self-report of dyspnea visual analog scale (D-VAS)	To assess self-report of dyspnea visual analog scale (D-VAS) to predict a device failure. Minimum is 0 and maximum is 10, the higher score means worse outcome. When the score > 3, it likely indicates dyspnea and being used for quality of palliative care unit	The parameter is measured at the time of enrolment. Failure of HFNC or NIV is adjudicated at 7 days.

Collaborators and Investigators

• Sponsor: Unity Health Toronto

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2025
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: November 28, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Estimated): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 15, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Non-invasive ventilation; Diaphragm; Weaning failure; High flow nasal cannula; Electrical impedance tomography; Post-extubation; Hypoxemic respiratory failure
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypoventilation
• Other Study ID Numbers: Unity Health Toronto

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No