Astral VAPS AutoEPAP Clinical Trial

NCT02683772 | Completed Phase 3 Results FDA Device

• 1 other identifier: MA-15-12-15
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 5

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.

Conditions

Upper Airway Obstruction; Respiratory Insufficiency; Respiratory Failure

Keywords

NIV, NIPPV, ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Sleep Efficiency (%)

  Overnight, up to 8 hrs on nights 1 and 2

• Apnea Hypopnea Index (AHI)

  Overnight, up 8 hrs on night 1 and 2

• Nadir Arterial Oxygen Saturation (SpO2)

  Overnight, up 8 hrs on night 1 and 2

• Arterial Carbon Dioxide (PCO2)

  Overnight, up 8 hrs on night 1 and 2

Study Arms (2)

iVAPS with AutoEPAP

EXPERIMENTAL

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

iVAPS with manual EPAP

ACTIVE COMPARATOR

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

Interventions

Astral DEVICE

Astral ventilator

iVAPS with AutoEPAP; iVAPS with manual EPAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ResMed: lead

Study Sites (5)

University of California, San Diego

La Jolla, California, 92037, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Lisa F. Wolfe, MD

Chicago, Illinois, 60611, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (7)

• Budweiser S, Jorres RA, Riedl T, Heinemann F, Hitzl AP, Windisch W, Pfeifer M. Predictors of survival in COPD patients with chronic hypercapnic respiratory failure receiving noninvasive home ventilation. Chest. 2007 Jun;131(6):1650-8. doi: 10.1378/chest.06-2124.

  PMID: 17565016 BACKGROUND

• Masa JF, Celli BR, Riesco JA, Hernandez M, Sanchez De Cos J, Disdier C. The obesity hypoventilation syndrome can be treated with noninvasive mechanical ventilation. Chest. 2001 Apr;119(4):1102-7. doi: 10.1378/chest.119.4.1102.

  PMID: 11296176 BACKGROUND

• Remmers JE, deGroot WJ, Sauerland EK, Anch AM. Pathogenesis of upper airway occlusion during sleep. J Appl Physiol Respir Environ Exerc Physiol. 1978 Jun;44(6):931-8. doi: 10.1152/jappl.1978.44.6.931. No abstract available.

  PMID: 670014 BACKGROUND

• Ward S, Chatwin M, Heather S, Simonds AK. Randomised controlled trial of non-invasive ventilation (NIV) for nocturnal hypoventilation in neuromuscular and chest wall disease patients with daytime normocapnia. Thorax. 2005 Dec;60(12):1019-24. doi: 10.1136/thx.2004.037424.

  PMID: 16299118 BACKGROUND

• Laghi F, Tobin MJ. Disorders of the respiratory muscles. Am J Respir Crit Care Med. 2003 Jul 1;168(1):10-48. doi: 10.1164/rccm.2206020.

  PMID: 12826594 BACKGROUND

• Suh ES, Murphy PB. Auto-titration of EPAP during NIV: A better night's sleep? Respirology. 2019 Dec;24(12):1132-1133. doi: 10.1111/resp.13587. Epub 2019 May 23. No abstract available.

  PMID: 31120585 DERIVED

• Orr JE, Coleman J, Criner GJ, Sundar KM, Tsai SC, Benjafield AV, Crocker ME, Willes L, Malhotra A, Owens RL, Wolfe LF. Automatic EPAP intelligent volume-assured pressure support is effective in patients with chronic respiratory failure: A randomized trial. Respirology. 2019 Dec;24(12):1204-1211. doi: 10.1111/resp.13546. Epub 2019 Apr 22.

  PMID: 31012225 DERIVED

MeSH Terms

Conditions

Airway Obstruction; Respiratory Insufficiency; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Maureen Crocker, Manager Medical Affairs
• Organization: ResMed

maureen.crocker@resmed.com

8588366653

Study Officials

• Lisa Wolfe, MD

  Northwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients were masked to the mode of treatment. The Core Lab was masked to the mode of treatment for all patients.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2016
• First Posted: February 17, 2016
• Study Start: April 15, 2016
• Primary Completion: March 1, 2017
• Study Completion: July 6, 2017
• Last Updated: July 26, 2019
• Results First Posted: July 26, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)