Astral VAPS AutoEPAP Clinical Trial
Astral VAPS AutoEPAP Clinical Trial
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.
Inclusion criteria for the study are:

 1. Participant has ability to provide written informed consent

 2. Participants aged ≥18 years old

 3. Participant has documented respiratory failure (e.g. sleep hypoventilation with
 historical PtCO2 increase ≥ 10mmHg) and/or daytime hypercapnia (>45 mmHg)

 4. Participant is currently using non-invasive positive pressure ventilation in ST or
 VAPS mode for ≥ 3 months

 5. Participants with a previously documented AHI ≥ 5/hr

 6. Participants with a recently (≤ 12 months ago) reviewed EPAP setting

 Exclusion criteria for the study are:

 1. Participants are not compliant on NIPPV (e.g. < 4 hr/night)

 2. Participants who are pregnant

 3. Participants on oxygen therapy ≥5 L/min

 4. Participants with an invasive interface (e.g. tracheostomy)

 5. Participants who have had an acute exacerbation within the last 3 months that resulted
 in a hospitalisation

 6. Participants who are acutely ill, medically complicated or who are medically unstable

 7. Participants in whom NIPPV therapy is otherwise medically contraindicated

 8. Participants who have had surgery of the upper airway, nose, sinus, or middle ear
 within the previous 90 days

 9. Participants with untreated, non-OSA sleep disorders, including but not limited to;
 insomnia, periodic limb movement syndrome, or restless legs syndrome.

 10. Participants who have the following pre-existing conditions: severe bullous lung
 disease, recurrent pneumothorax or pneumomediastinum, cerebrospinal fluid leak, recent
 cranial surgery or trauma.

 11. Participant does not comprehend English

 12. Participant is unable or unwilling to provide written informed consent

 13. Participant is physically and/or mentally unable to comply with the protocol

 14. Participant is not suitable to participate in the trial for any other reason in the
 opinion of the investigator