Ventilatory FailurePREVISIONNCT06716463
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
An observational study of Ventilatory Failure and Hypoxemic Respiratory Failure, run by Unity Health Toronto at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilatory Failure, Hypoxemic Respiratory Failure, Weaning Failure
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 27 Jan 2025to Jun 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age of ≥ 18 years
- Using NIV or HFNC anywhere in the hospital
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Laurent J. Brochard, MD, 416-864-6060 ext. 5686, laurent.brochard@unityhealth.to
About this study
Official title: 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?
Read the 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.
- Keywords
- Electrical impedance tomography, High flow nasal cannula, Non-invasive ventilation, Diaphragm, Weaning failure, Post-extubation, Hypoxemic respiratory failure
- Medical subject headings
- Hypoventilation, Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in regional ventilation distribution (%)
The primary endpoint is to assess regional ventilation distribution (%) when using HFNC or NIV to predict a device failure.
Measured: 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
To assess ultrasound measurement of inspiratory muscle activity when using HFNC or NIV to predict a device failure.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: The parameter is measured at the time of enrolment. Failure of HFNC or NIV is adjudicated at 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start27 Jan 2025
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilatory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716463
- Sponsor's protocol ID
- Unity Health Toronto
- Acronym
- PREVISION
- Status last verified
- May 2025
- First submitted
- 25 Nov 2024
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06716463
- Acronym / sponsor ID
- PREVISION / Unity Health Toronto
- Keywords
- Electrical impedance tomography, High flow nasal cannula, Non-invasive ventilation, Diaphragm, Weaning failure, Post-extubation, Hypoxemic respiratory failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age of ≥ 18 years
- Using NIV or HFNC anywhere in the hospital
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in regional ventilation distribution (%)
Time frame: The parameter is measured at the time of enrolment. Failure of HFNC or NIV is adjudicated at 7 days.
The primary endpoint is to assess regional ventilation distribution (%) when using HFNC or NIV to predict a device failure.
7 secondary outcomes
Diaphragm or parasternal intercostal muscle thickening fraction
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: The parameter is measured at the time of enrolment. Failure of HFNC or NIV is adjudicated at 7 days.
The work of breathing scale
Time frame: 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)
Time frame: The parameter is measured at the time of enrolment. Failure of HFNC or NIV is adjudicated at 7 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilatory Failure and Hypoxemic Respiratory Failure, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in regional ventilation distribution (%) (time frame: The parameter is measured at the time of enrolment. Failure of HFNC or NIV is adjudicated at 7 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.