Astral VAPS AutoEPAP Clinical Trial

ResMed

Status and phase: Completed; Phase 3

Conditions: Respiratory Failure; Respiratory Insufficiency; Upper Airway Obstruction

Treatments: Device: Astral

Study type: Interventional

Funder types: Industry

Identifiers

NCT02683772

MA-15-12-15

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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42 participants in 2 patient groups

iVAPS with AutoEPAP

Experimental group

Description:

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.

Treatment:

Device: Astral

iVAPS with manual EPAP

Active Comparator group

Description:

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.

Treatment:

Device: Astral