A Pilot Study to Assess the Effects of a Novel Application of Averaged Volume Assured Pressure Support Ventilation (AVAPS-AE) Therapy on Re-hospitalization in Patients With Sleep-Disordered Breathing With Co-morbid COPD
Stopped early · Not applicable
Conditions studied: Breathing-Related Sleep Disorder
In brief
This is a multicenter, randomized, parallel-group, open label study of the efficacy of AVAPS-AE to prevent re-hospitalization in hospitalized patients with comorbid Chronic Obstructive Pulmonary Disease (COPD).
Key facts
- Study ID
- NCT02446769
- Run by
- Philips Respironics
- People needed
- 18
- Starts
- 2017-10-06
- Expected to finish
- 2018-05-21
- Last updated by the study team
- 2020-08-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Hospitalized patients who are at high risk for readmission who are at least 18 years of age.
- Specifically patients with (a) admission diagnosis of COPD AND (b) either a prior non-elective hospitalization (One in the past 12 months) OR active smoker who are ready for discharge AND (c) are also found to have sleep-disordered breathing (AHI ≥ 10 per hour; >3% oxygen desaturation for hypopneas) by overnight portable respiratory study prior to hospital discharge.
- Bedside spirometry revealing evidence for obstructive lung disease (post-bronchodilator; GOLD stage II or greater (FEV1 <70% predicted post BD).
- No previous home Positive Airway Pressure (PAP) or Non- Invasive Ventilation (NIV) use within the past year
You may not qualify if…
- Central sleep apnea (Central apnea index >5 per hour; and/or >50% are central apneas \& hypopneas)
- Clinically unstable, i.e., Acute Respiratory Failure, hypotensive shock, uncontrolled cardiac ischemia or arrhythmias, requiring life support ventilation or as otherwise determined by the investigator
- Participants with Stage III \& IV Chronic Heart Failure as defined by the New York Heart Association (NYHA) Classification
- Known or expected contraindications for the use of non-invasive ventilation per the assessment of the investigator.
- Lack of medical insurance
Where it is running
- University of Arizona — Tucson, Arizona, United States
Full record on ClinicalTrials.gov
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