An observational study in Acute Hypercapnic Respiratory Failure, sponsored by Unity Health Toronto. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-20.
Sponsored by Unity Health Toronto · Observational
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Among 13 studies in Respiratory Insufficiency by Unity Health Toronto — 4 open to participants now, 5 under way, none of them phase 3. Respiratory Insufficiency · Unity Health Toronto.
Among the 13 studies in Respiratory Insufficiency by Unity Health Toronto, this one is the only one that started in 2021, is one of 8 observational ones, and was the 10th registered.
1,369 studies on the registry are indexed under Respiratory Insufficiency; 264 are open to participants now.
Browse Respiratory Insufficiency studies →4 of the 13 studies in Respiratory Insufficiency by Unity Health Toronto are open now, in 1 country. Recruiting first, the newest first:
Unity Health Toronto · Sites in Canada
Ages 18+
Unity Health Toronto · Sites in Canada
Ages 40+
Unity Health Toronto · Sites in Canada
Ages 18+
By country, each count listing its studies:
Of the 180 Respiratory Insufficiency studies recruiting now, 135 (75%) set no upper age limit and 18 (10%) stop at 75 or younger; 21 take children under 18; 20 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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13 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2021.
This study's planned enrollment of 50 is below the median of 100 across 455 observational studies indexed under Respiratory Insufficiency.
Median enrollment 16 across the 5 interventional studies, 78 across the 8 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
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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.
1 of the studies in Respiratory Insufficiency by Unity Health Toronto that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06716463Unity Health TorontoPREdicting 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 | 2027-06 |
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Among the 13 studies in Respiratory Insufficiency by Unity Health Toronto, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The high frequency of unplanned hospital visits of patients with chronic hypercapnic respiratory failure (e.g., chronic obstructive pulmonary disease, obesity-related hypoventilation) constitutes a major public health problem. Most patients admitted for acute exacerbations (AHRF) have additional comorbidities, especially sleep disorders. Often untreated, sleep disorders contribute to multiple readmissions (≈70% at one year) and increase readmission costs. The investigators will: 1) identify these patients early during unplanned hospital admissions and perform sleep studies using EEG and oximetry before hospital discharge and two months after to compare sleep abnormalities in the two moments; 2) investigate the association between sleep abnormalities in the two sleep studies with clinical outcomes (1-year readmission and death); 3) investigate the acute effects of high-flow nasal cannula (HFNC) to treat sleep abnormalities as a simplified alternative. The investigators anticipate sleep abnormalities during the hospital stay and two months after discharge will be associated with poor clinical outcomes (readmission, death) and HFNC to acutely reduce sleep abnormalities.
The investigators will perform sleep studies using nocturnal EEG measurements and oximetry 1) while the participants are still in the hospital but have reached relative clinical stability (≥48 h after admission, not in ICU and pHv ≥7.36) and 2) two months after hospital discharge at the participant's home. Sleep studies will be performed from 5:00 pm to 8 am. EEG measurements will be performed using a portable monitor (Prodigy Sleep System, Cerebra, Winnipeg, Canada). Sleep assessment will be performed offline. The ORP will be continuously quantified and ORP-derived indices will be calculated. Nocturnal oximetry will be used for detecting sleep desaturation episodes. Comorbidities (e.g., obesity, diagnosed lung or heart disease, Charlson comorbidity index) and exacerbations/hospitalization in the previous year will be identified.
In 21 participants, the investigators will perform one additional sleep study with the participants breathing with high-flow nasal cannula therapy (HFNC) to investigate the acute impact (i.e., during one night) of HFNC on reducing sleep abnormalities. HFNC will be set from 25 - 60 L/min based on participant's tolerance and the inspired fraction of oxygen will be titrated to maintain patient SpO2 similar to the levels during standard oxygen therapy.
Patients with acute hypercapnic respiratory failure (pH \<7.35 and PaCO2 > 45 mmHg at admission) admitted for an unplanned hospitalization or emergency room visit.
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Exclusion Criteria:
Acute Hypercapnic Respiratory Failure patients with Sleep Disorders
Device: High-flow nasal cannula therapy
Acute Hypercapnic Respiratory Failure patients without Sleep Disorders
Device: High-flow nasal cannula therapy
High-flow nasal cannula therapy (HFNC) (from 25 - 60 L/min based on patient's tolerance) will be used in 21 participants during one additional sleep study to investigate its acute impact on reducing sleep abnormalities. Inspired fraction of oxygen will be titrated to maintain patient SpO2 similar to the levels during standard oxygen therapy.
1-year hospital readmission and 1-year mortality
The primary endpoint is to compare the rate of 1-year Hospital readmission and mortality between patients with acute hypercapnic respiratory failure with vs. without sleep abnormalities during the home sleep study measured by the odds ratio product (ORP) and the 2017 American Academy of Sleep Medicine rules
Time frame: 1 year
Hospital length of stay
The secondary endpoint is to compare the length of stay during the hospital admission between patients with acute hypercapnic respiratory failure with vs. without sleep abnormalities during the sleep study performed at the hospital measured by the odds ratio product (ORP) and the 2017 American Academy of Sleep Medicine rules
Time frame: Through study completion, an average of 1 year
Need of ventilatory support
The secondary endpoint is to compare the need of invasive and non-invasive ventilatory support between patients with acute hypercapnic respiratory failure with vs. without sleep abnormalities during the sleep study performed at the hospital measured by the odds ratio product (ORP) and the 2017 American Academy of Sleep Medicine rules
Time frame: Through study completion, an average of 1 year
Need of ICU admission
The secondary endpoint is to compare the need of ICU admission between patients with acute hypercapnic respiratory failure with vs. without sleep abnormalities during the sleep study performed at the hospital measured by the odds ratio product (ORP) and the 2017 American Academy of Sleep Medicine rules
Time frame: Through study completion, an average of 1 year
In-hospital mortality
The secondary endpoint is to compare the rate of in-hospital mortality between patients with acute hypercapnic respiratory failure with vs. without sleep abnormalities during the sleep study performed at the hospital measured by the odds ratio product (ORP) and the 2017 American Academy of Sleep Medicine rules
Time frame: Through study completion, an average of 1 year
HFNC effects on sleep depth according to the ORP range
In 21 patients. Time spend in different ORP ranges during the sleep study which the patients used the standard oxygen therapy and the night which the patients used HFNC.
Time frame: 15 hours
Sleep depth according to the ORP during the sleep study performed at the hospital and at home
Time spend in different ORP ranges during the sleep study performed in the hospital vs. at home.
Time frame: 15 hours
HFNC effects on sleep depth according to the AASM criteria
In 21 patients. Time spend in different sleep stages (AASM 2017 rules) during the sleep study which the patients used the standard oxygen therapy and the night which the patients used HFNC.
Time frame: 15 hours
HFNC effects on the prevalence of sleep abnormalities
In 21 patients. The prevalence of sleep abnormalities during the sleep study which the patients used the standard oxygen therapy and the night which the patients used HFNC.
Time frame: 15 hours
Sleep depth according to the AASM at the hospital vs. home
Time spend in different sleep stages (AASM 2017 rules) during the sleep study performed at the hospital vs. at patient's home.
Time frame: 15 hours
Prevalence of sleep abnormalities at the hospital vs. home
The prevalence of sleep abnormalities during the sleep study performed at the hospital vs. at home.
Time frame: 15 hours
Plan to share: No
Started Sep 2021 (actual). Primary completion is estimated for Jul 2026, 58 months after the start.
Of 232 non-industry observational studies under Respiratory Insufficiency, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 54. This study's planned 58 months is above that.
Counting every sponsor, half of 248 studies reached it within 22 months; a quarter within 12 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
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