Recruiting

HFNC

Sponsor:

Unity Health Toronto

Code:

NCT05011877

Conditions

Acute Hypercapnic Respiratory Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

High-flow nasal cannula therapy

Study Details

Brief summary:

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.

Conditions

Acute Hypercapnic Respiratory Failure

Study ID

NCT05011877

Start date

Sep 1, 2021

Status verified date

May, 2025

Completion date

Jul 1, 2026

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult patients requiring an unplanned hospitalization or emergency room visit due to an acute hypercapnic respiratory failure exacerbation (AHRF), not on home noninvasive or invasive ventilation, neuromuscular disease (e.g., spinal cord injury) or central nervous system disorders (e.g., cerebral vascular accident, Alzheimer), absence of tracheotomy, and non-morbidly obese.

Exclusion Criteria:

  • Patients with AHRF due to drug overdose
  • Ventilatory support (noninvasive or invasive ventilation) is needed before or during the sleep studies or if an acute deterioration (e.g., cerebral vascular accident, cardiac arrest) happens before or during the sleep studies.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Acute Hypercapnic Respiratory Failure patients with Sleep Disorders

Acute Hypercapnic Respiratory Failure patients with Sleep Disorders

Acute Hypercapnic Respiratory Failure patients without Sleep Disorders

Acute Hypercapnic Respiratory Failure patients without Sleep Disorders

Interventions

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.

Primary outcome measure

  • 1-year hospital readmission and 1-year mortality [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Laurent Brochard, MD, MD, HDR

4168645686

Principal Investigator:

Laurent Brochard

More Information

Sponsor

Unity Health Toronto

Last update posted

May 20, 2025

Last verified

May, 2025

Keywords

  • Acute Hypercapnic Respiratory Failure
  • Patient Readmission
  • Mortality
  • Sleep Disorders, Intrinsic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2025-05-20.