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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Ventilatory Failure, Hypoxemic Respiratory Failure, Weaning Failure, Respiratory. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Primary outcome measures
- 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.]
Secondary outcome measures (7)
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- St. Michael's Hospital — Toronto
Identifiers
NCT: NCT06716463 · Unity Health Toronto