Patients with chronic respiratory failure such as those associated with Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS), Obstructive Sleep Apnea (OSA) or Neuromuscular Disease (NMD) are increasingly managed with domiciliary non-invasive positive pressure ventilation (NIPPV). The aim of this study is to now compare the Automatic Expiratory Positive Airway Pressure (AutoEPAP) algorithm with a fixed manual EPAP in iVAPS mode on an Astral mixed mode ventilator. It is proposed that the automatic settings of AutoEPAP will be as effective at managing respiratory failure and upper airway obstruction (UAO) as manual EPAP on the Astral device. Specifically demonstrating that the AutoEPAP function is as effective at treating UAO as manual EPAP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
42
Astral ventilator
University of California, San Diego
La Jolla, California, United States
National Jewish Health
Denver, Colorado, United States
Lisa F. Wolfe, MD
Chicago, Illinois, United States
Temple University
Philadelphia, Pennsylvania, United States
University of Utah
Salt Lake City, Utah, United States
Oxygen Desaturation Index 4% (ODI4%)
Mean paired difference AutoEPAP-manual EPAP: Comparison of Oxygen Desaturation Index 4% (ODI4%) values between groups by using mean ODI4% (#events/hour). A cross-over analysis was generated to investigate the influence of a possible period effect on the primary endpoint, paired change in ODI4% between Auto and manual EPAP
Time frame: Overnight, up to 8 hrs on nights 1 and 2
Sleep Efficiency (%)
To assess sleep efficacy between groups by using rapid eye movement sleep (REM) (% of total sleep time)
Time frame: Overnight, up to 8 hrs on nights 1 and 2
Apnea Hypopnea Index (AHI)
To assess sleep-breathing parameters between groups using mean AHI (#events/hour)
Time frame: Overnight, up 8 hrs on night 1 and 2
Nadir Arterial Oxygen Saturation (SpO2)
To assess Sleep-breathing parameters between groups using mean SpO2 (%)
Time frame: Overnight, up 8 hrs on night 1 and 2
Arterial Carbon Dioxide (PCO2)
To assess Sleep-breathing parameters between groups using mean PCO2 (mmHg)
Time frame: Overnight, up 8 hrs on night 1 and 2
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