Astral VAPS AutoEPAP Clinical Trial
Condition: Upper Airway Obstruction; Respiratory Insufficiency; Respiratory Failure
MeSH terms: Respiratory Insufficiency; Airway Obstruction
Intervention: Astral
Intervention description: Astral ventilator
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Masking description: Patients were masked to the mode of treatment. The Core Lab was masked to the mode of treatment for all patients.
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NIV, NIPPV, ventilation

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:

          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