Astral VAPS AutoEPAP Clinical Trial

Study Overview
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Brief Summary
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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.

Official Title
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The Evaluation of the Astral VAPS AutoEPAP Treatment Algorithm

Conditions
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Upper Airway Obstruction, Respiratory Insufficiency, Respiratory Failure

Intervention / Treatment
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* Device: Astral


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iVAPS with AutoEPAP<br>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. | Device: Astral<br>* Astral ventilator<br>|
| Active Comparator: iVAPS with manual EPAP<br>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. | Device: Astral<br>* Astral ventilator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen Desaturation Index 4% (ODI4%) | Mean paired difference AutoEPAP-manual EPAP: Comparison of Oxygen Desaturation Index 4% (ODI4%) values between groups by using mean ODI4% (#events/hour). A cross-over analysis was generated to investigate the influence of a possible period effect on the primary endpoint, paired change in ODI4% between Auto and manual EPAP | Overnight, up to 8 hrs on nights 1 and 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Efficiency (%) | To assess sleep efficacy between groups by using rapid eye movement sleep (REM) (% of total sleep time) | Overnight, up to 8 hrs on nights 1 and 2 | 
| Apnea Hypopnea Index (AHI) | To assess sleep-breathing parameters between groups using mean AHI (#events/hour) | Overnight, up 8 hrs on night 1 and 2 | 
| Nadir Arterial Oxygen Saturation (SpO2) | To assess Sleep-breathing parameters between groups using mean SpO2 (%) | Overnight, up 8 hrs on night 1 and 2 | 
| Arterial Carbon Dioxide (PCO2) | To assess Sleep-breathing parameters between groups using mean PCO2 (mmHg) | Overnight, up 8 hrs on night 1 and 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NIV, NIPPV, ventilation