An interventional study of Non Invasive Ventilation and High Flow Oxygen Cannula 50 in Exacerbation Copd, Acute Respiratory Distress and Acute Hypercapnic Respiratory Failure, sponsored by Unity Health Toronto. Recruiting at 1 site in Canada. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-05-20.
Sponsored by Unity Health Toronto · Not applicable, Interventional, and Treatment
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Among 16 studies in Acute Lung Injury with a site in Canada — 4 open to participants now, 4 under way, 1 of them phase 3. Acute Lung Injury · Canada.
Among the 16 studies in Acute Lung Injury with a site in Canada, this one is the 11th largest by planned enrollment of the 13 interventional ones that give a count, is the only one that started in 2018, is one of 4 with no phase, and was the 13th registered.
382 studies on the registry are indexed under Acute Lung Injury; 73 are open to participants now.
Browse Acute Lung Injury studies →4 of the 16 studies in Acute Lung Injury with a site in Canada are open now. Recruiting first, the newest first:
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in Canada, United States
Ages 12+
Children's Hospital Los Angeles · Sites in Canada, United States, Italy
Ages 1 mo–18 yrs
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal · Sites in Canada
Ages 18–75
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 45 Acute Lung Injury studies recruiting now, 25 (56%) set no upper age limit and 8 (18%) stop at 75 or younger; 6 take children under 18; 7 take healthy volunteers.
This study: 40 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 6 · Phase 3 3
First in 2001; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 60 across 227 interventional studies indexed under Acute Lung Injury.
Median enrollment 90 across the 13 interventional studies, 362 across the 2 observational. Of the 10 that completed or were terminated, 4 (40%) have results posted.
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4 of 16 have an industry lead sponsor. The 10 most frequent:
Unity Health Toronto is the lead sponsor of 447 studies on the registry; 82 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Unity Health Toronto has 2 studies filed under Acute Lung Injury — fewer than ten, so there is no comparison to draw.
2 of the studies in Acute Lung Injury with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06476132National Institute of Allergy and Infectious Diseases (NIAID)Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients | 2027-05-30 |
| NCT04068012Children's Hospital Los AngelesClinical Decision Support Tool in PARDS Pilot Study | 2027-07 |
Add all 2 to your calendar (.ics) → With an account.
Among the 16 studies in Acute Lung Injury with a site in Canada, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Chronic obstructive lung disease is a disabling disease that affects people usually after several years of smoke tobacco exposure and affects millions of patients worldwide. The disease is marked by multiples episode of worsening, termed exacerbations necessitating frequent hospitalizations. During these exacerbations, patients present breathless, and in the most severe cases, are admitted to an Intensive Care Unit (ICU) for respiratory assistance. Currently, respiratory assistance is provided by a ventilator via a oronasal mask (referred to non-invasive ventilation, NIV), that helps patients to cope with their breathless. The mask is not always well tolerated and the ventilator sessions are delivered intermittently. In the past decade, a new technique that provides air-oxygen with high flow has been developed. This technique, called High Flow via Nasal Cannula (HFNC) can deliver from 21 to 100% heated and humidified air-oxygen at a high flow of gas via simple nasal cannula. Recent studies have shown that the technique is very efficient to treat patients presenting with acute respiratory failure who don't have any underlying chronic pulmonary disease. Whether the technique would be also efficient in patients with COLD presenting with severe exacerbations has not yet been demonstrated. Since HFNC does not require any mask, it is thought that the comfort of the patient would be much better in comparison to NIV and could potentially help to treat many patients with the disease. The objective of the present study is to study the physiological effect of HFNC as compared to NIV in patients with severe exacerbations of COPD and to show that it is non-inferior to NIV.
Design: Prospective, observational, cross-over, clinical physiologic study of HFNC and NIV in patients with COPD and hypercapnic respiratory failure Intervention: Participants will be consecutively ventilated with the two devices, i.e., HFNC and NIV. HFNC 30 and 50 L/min will be applied in a random order (sealed, opaque envelope). HFNC will be set with a temperature at 37°C or 34°C if perceived as too warm. NIV settings will be adjusted based on the clinical assessment of the Respiratory Therapist as per standard practice and will not be modified during the test. In both groups, FiO2 will be adjusted to achieve a SpO2 of at least 92%.
Setting: The intervention will be applied in the Medical-Surgical ICU of St. Michael's Hospital.
Duration: Each device will be studied for up to 30 minutes. The entire study will take place over up to 3 hours. There is no additional follow-up thereafter.
Procedures: The study will start first by recording patients under spontaneous breathing considered as a baseline (sequence #1). Under spontaneous breathing, patients will be receiving oxygen therapy as it is usually done between 2 NIV sessions. Then, the patient will have up to 30 minutes to acclimatize to HFNC and select his/her preferred flow rate (sequence #2). NIV will be applied (sequence #3). The NIV settings will be adjusted based on the clinical assessment of the Respiratory Therapist and will not be modified throughout the study. Then, according to randomization order (sealed envelopes), patients will receive a flow corresponding to the preferred flow selected by the patient and a second flow, either HFNC 30 L/min or HFNC 50 L/min depending on the initial choice (sequences #4 and #5) (see flow diagram). FiO2 will be adjusted to achieve a SpO2 of 90 to 94%. Each condition will be studied fup to 30 minutes and will be separated by a 5-minute washout period during which patients will be receiving oxygen therapy. The measurements will be collected at baseline (under spontaneous breathing) and during the last five minutes of each condition. In case of clinical intolerance as considered by the attending physician, the study will stop. In case the patient is considered dependent of NIV by clinicians, we will still enroll the patient without doing baseline period after discussion with clinicians.
The pulse oximeter (SpO2) and transcutaneous CO2 monitor (SenTec Digital Monitoring System (SDMS)) will be continuously monitored throughout the study period. Exspiron or Electrical Impedance Tomography (EIT) device will be calibrated to measure minute ventilation. Four surface electrodes will be placed bilaterally to record each hemidiaphragm activity using a specific recording system (Acqknowledge software, Biopac Systems) A bedside ultrasound examination will be performed, using a SonoSite system (Fujifilm) equipped with a 10-15 MHz ultrasound linear probe. Diaphragm thickness will be measured both at end-inspiration and end-expiration. This technique will be applied at the end of each sequence (before ventilatory assist under conventional O2 therapy). In patients becoming rapidly intolerant to NIV disconnection, we will limit this "baseline" period under O2 to a minimum (5 minutes). The thickness and contraction of the intercostal muscles and abdominal muscles will also be assessed.
Interpretation of the ultrasound results to determine diaphragm and other muscle thickness will be read at a later time by an individual blinded to the intervention.
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exacerbation and acute hypercapnic respiratory failure with acute respiratory failure defined by
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive non invasive ventilation with setting decided by the attending physician.
Device: Non Invasive Ventilation
High Flow Oxygen Cannula with a flow set at 50 L/min.
Device: High Flow Oxygen Cannula 50
High Flow Oxygen Cannula with a flow set at 30 L/min.
Device: High Flow Oxygen Cannula 30
Patients will receive non invasive ventilation as a standard of care.
Also known as: Standard of Care
Patients will receive High Flow Oxygen Cannula with a flow set at 50 L/min
Also known as: HFNO 50
Patients will receive High Flow Oxygen Cannula with a flow set at 30 L/min
Also known as: HFNO 30
Change in work of breathing between NIV and HFNC
The primary endpoint is to compare the decrease in work of breathing under HFNC to the decrease in work of breathing under NIV. The work of breathing will be assessed with diaphragm ultrasound (measurement of the diaphragm thickening fraction).
Time frame: 30 minutes
Change in Work of breathing between HFNC 50 and 30 L/min
The secondary endpoints include comparison of the work of breathing under HFNC (50L/min vs 30 L/min). The work of breathing will be assessed with diaphragm ultrasound (measurement of the diaphragm thickening fraction).
Time frame: 30 minutes
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2018 to primary completion in Apr 2025, 79 months.
Of 51 non-industry interventional studies with no phase under Acute Lung Injury, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's 79 months is above that.
Counting every sponsor, half of 52 studies reached it within 15 months; a quarter within 7 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
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