Astral VAPS AutoEPAP Clinical Trial

Phase 3

Completed

• Conditions: Respiratory Failure; Upper Airway Obstruction; Respiratory Insufficiency
• Interventions: Device: Astral

• Registration Number: NCT02683772
• Lead Sponsor: ResMed

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-03
• Study First Submitted QC: 2016-02-10
• Study First Posted: 2016-02-17
• Study Start: 2016-04-15
• Primary Completion: 2017-03-01
• Study Completion: 2017-07-06
• Disposition First Submitted: 2018-03-07
• Disposition First Submitted QC: 2018-03-07
• Disposition First Posted: 2018-03-09
• Results First Submitted: 2018-03-21
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-18
• Last Update Submitted: 2019-07-18
• Results First Posted: 2019-07-26
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
iVAPS with AutoEPAP	Astral	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.
iVAPS with manual EPAP	Astral	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.

Primary Outcome Measures

Name	Time	Method
Oxygen Desaturation Index 4% (ODI4%)	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 Outcome Measures

Name	Time	Method
Apnea Hypopnea Index (AHI)	Overnight, up 8 hrs on night 1 and 2	To assess sleep-breathing parameters between groups using mean AHI (#events/hour)
Arterial Carbon Dioxide (PCO2)	Overnight, up 8 hrs on night 1 and 2	To assess Sleep-breathing parameters between groups using mean PCO2 (mmHg)
Sleep Efficiency (%)	Overnight, up to 8 hrs on nights 1 and 2	To assess sleep efficacy between groups by using rapid eye movement sleep (REM) (% of total sleep time)
Nadir Arterial Oxygen Saturation (SpO2)	Overnight, up 8 hrs on night 1 and 2	To assess Sleep-breathing parameters between groups using mean SpO2 (%)

Trial Locations

Locations (5)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

University of California, San Diego; 🇺🇸 La Jolla, California, United States

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States

Lisa F. Wolfe, MD; 🇺🇸 Chicago, Illinois, United States

National Jewish Health; 🇺🇸 Denver, Colorado, United States