Astral VAPS AutoEPAP Clinical Trial

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-15

Study Completion Date

2017-07-06

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.

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Detailed Description

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Conditions

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Upper Airway Obstruction Respiratory Insufficiency Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Patients were masked to the mode of treatment. The Core Lab was masked to the mode of treatment for all patients.

Study Groups

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iVAPS with AutoEPAP

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.

Group Type EXPERIMENTAL

Astral

Intervention Type DEVICE

Astral ventilator

iVAPS with manual EPAP

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.

Group Type ACTIVE_COMPARATOR

Astral

Intervention Type DEVICE

Astral ventilator

Interventions

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Astral

Astral ventilator

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No