NCT02683772

Astral VAPS AutoEPAP Clinical Trial

The Evaluation of the Astral VAPS AutoEPAP Treatment Algorithm

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: ResMed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Upper Airway Obstruction
• Respiratory Insufficiency
• Respiratory Failure

Interventions

Type	Name	Description
DEVICE	Astral	Astral ventilator

Timeline

• Start date: 2016-04-15
• Primary completion: 2017-03-01
• Completion: 2017-07-06
• First posted: 2016-02-17
• Last updated: 2019-07-26
• Results posted: 2019-07-26

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study