Phase 3
N=38
Astral VAPS AutoEPAP Clinical Trial
Upper Airway Obstruction · Respiratory Insufficiency · Respiratory Failure
Bottom Line
View on ClinicalTrials.gov: NCT02683772 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Oxygen Desaturation Index 4% (ODI4%) — 3.16; 7.61 events per hour — p=0.0134
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Astral (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ResMed
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oxygen Desaturation Index 4% (ODI4%) |
3.16; 7.61 | 0.0134 sig |
| SECONDARY Sleep Efficiency (%) |
73.70; 73.89 | — |
| SECONDARY Apnea Hypopnea Index (AHI) |
4.71; 7.84 | — |
| SECONDARY Nadir Arterial Oxygen Saturation (SpO2) |
94.24; 94.53 | — |
| SECONDARY Arterial Carbon Dioxide (PCO2) |
45.49; 45.38 | — |
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.
Eligibility Criteria
Inclusion criteria for the study are:
- Participant has ability to provide written informed consent
- Participants aged ≥18 years old
- Participant has documented respiratory failure (e.g. sleep hypoventilation with historical PtCO2 increase ≥ 10mmHg) and/or daytime hypercapnia (>45 mmHg)
- Participant is currently using non-invasive positive pressure ventilation in ST or VAPS mode for ≥ 3 months
- Participants with a previously documented AHI ≥ 5/hr
- Participants with a recently (≤ 12 months ago) reviewed EPAP setting
Exclusion criteria for the study are:
- Participants are not compliant on NIPPV (e.g. < 4 hr/night)
- Participants who are pregnant
- Participants on oxygen therapy ≥5 L/min
- Participants with an invasive interface (e.g. tracheostomy)
- Participants who have had an acute exacerbation within the last 3 months that resulted in a hospitalisation
- Participants who are acutely ill, medically complicated or who are medically unstable
- Participants in whom NIPPV therapy is otherwise medically contraindicated
- Participants who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days
- Participants with untreated, non-OSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome.
- Participants who have the following pre-existing conditions: severe bullous lung disease, recurrent pneumothorax or pneumomediastinum, cerebrospinal fluid leak, recent cranial surgery or trauma.
- Participant does not comprehend English
- Participant is unable or unwilling to provide written informed consent
- Participant is physically and/or mentally unable to comply with the protocol
- Participant is not suitable to participate in the trial for any other reason in the opinion of the investigator
Data sourced from ClinicalTrials.gov (NCT02683772). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.