A Strategy to Improve Management and Prolong LIFe Without Readmission for hYpercapnic Patients: The Simplify Project

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
St. Michael's Hospital
RECRUITING
Toronto
Contact Information
Primary
Laurent Brochard, MD, PhD
Laurent.Brochard@unityhealth.to
416-864-5686
Backup
Antenor Rodrigues, PT
Antenor.Rodrigues@unityhealth.to
Time Frame
Start Date: 2021-09-01
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 50
Treatments
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
Sponsors
Leads: Unity Health Toronto

This content was sourced from clinicaltrials.gov