The Evaluation of the Astral VAPS AutoEPAP Treatment Algorithm
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- ResMed
- Enrollment
- 42
- Locations
- 10
- Primary Endpoint
- Oxygen Desaturation Index 4% (ODI4%)
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Patients were masked to the mode of treatment. The Core Lab was masked to the mode of treatment for all patients.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
iVAPS with manual EPAP
This is a crossover study. During overnight PSG, Astral device will be set using iVAPS with manual EPAP on the first night, and on iVAPS with AutoEPAP on the second night.
Intervention: Astral (Device)
iVAPS with AutoEPAP
This is a crossover study. During overnight PSG, Astral device will be set using iVAPS with AutoEPAP on the first night, and on iVAPS with manual EPAP on the second night.
Intervention: Astral (Device)
Outcomes
Primary Outcomes
Oxygen Desaturation Index 4% (ODI4%)
Time Frame: Overnight, up to 8 hrs on nights 1 and 2
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
Secondary Outcomes
- Apnea Hypopnea Index (AHI)(Overnight, up 8 hrs on night 1 and 2)
- Arterial Carbon Dioxide (PCO2)(Overnight, up 8 hrs on night 1 and 2)
- Sleep Efficiency (%)(Overnight, up to 8 hrs on nights 1 and 2)
- Nadir Arterial Oxygen Saturation (SpO2)(Overnight, up 8 hrs on night 1 and 2)