Astral VAPS AutoEPAP Clinical Trial

Status:	Completed
Conditions:	Cardiology, Pulmonary
Therapuetic Areas:	Cardiology / Vascular Diseases, Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	4/17/2018
Start Date:	April 15, 2016
End Date:	July 6, 2017

The Evaluation of the Astral VAPS AutoEPAP Treatment Algorithm

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

We found this trial at

sites

The University of California, San Diego

9500 Gilman Dr
La Jolla, California 92093

(858) 534-2230