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Astral VAPS AutoEPAP Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02683772
Recruitment Status : Completed
First Posted : February 17, 2016
Results First Posted : July 26, 2019
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
ResMed

Brief 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.

Condition or disease Intervention/treatment Phase
Upper Airway Obstruction Respiratory Insufficiency Respiratory Failure Device: Astral Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
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.
Primary Purpose: Treatment
Official Title: The Evaluation of the Astral VAPS AutoEPAP Treatment Algorithm
Actual Study Start Date : April 15, 2016
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : July 6, 2017

Arm Intervention/treatment
Experimental: 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.
Device: Astral
Astral ventilator

Active Comparator: 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.
Device: Astral
Astral ventilator




Primary Outcome Measures :
  1. Oxygen Desaturation Index 4% (ODI4%) [ Time Frame: Overnight, up to 8 hrs on nights 1 and 2 ]
    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


Secondary Outcome Measures :
  1. Sleep Efficiency (%) [ Time Frame: Overnight, up to 8 hrs on nights 1 and 2 ]
    To assess sleep efficacy between groups by using rapid eye movement sleep (REM) (% of total sleep time)

  2. Apnea Hypopnea Index (AHI) [ Time Frame: Overnight, up 8 hrs on night 1 and 2 ]
    To assess sleep-breathing parameters between groups using mean AHI (#events/hour)

  3. Nadir Arterial Oxygen Saturation (SpO2) [ Time Frame: Overnight, up 8 hrs on night 1 and 2 ]
    To assess Sleep-breathing parameters between groups using mean SpO2 (%)

  4. Arterial Carbon Dioxide (PCO2) [ Time Frame: Overnight, up 8 hrs on night 1 and 2 ]
    To assess Sleep-breathing parameters between groups using mean PCO2 (mmHg)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683772


Locations
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United States, California
University of California, San Diego
La Jolla, California, United States, 92037
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
United States, Illinois
Lisa F. Wolfe, MD
Chicago, Illinois, United States, 60611
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
ResMed
Investigators
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Principal Investigator: Lisa Wolfe, MD Northwestern Medical Center
  Study Documents (Full-Text)

Documents provided by ResMed:
Study Protocol  [PDF] June 6, 2016
Statistical Analysis Plan  [PDF] September 23, 2016

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT02683772    
Other Study ID Numbers: MA-15-12-15
First Posted: February 17, 2016    Key Record Dates
Results First Posted: July 26, 2019
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by ResMed:
NIV, NIPPV, ventilation
Additional relevant MeSH terms:
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Respiratory Insufficiency
Airway Obstruction
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases