A Pilot Study to Assess the Effects of a Novel Application of Averaged Volume Assured Pressure Support Ventilation (AVAPS-AE) Therapy on Re-hospitalization in Patients With Sleep-Disordered Breathing With Co-morbid COPD

NCT02446769 | Terminated Results DMC FDA Device

• 1 other identifier: HRC-1426-BBACK-MS
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, parallel-group, open label study of the efficacy of AVAPS-AE to prevent re-hospitalization in hospitalized patients with comorbid Chronic Obstructive Pulmonary Disease (COPD).

Conditions

Breathing-Related Sleep Disorder

Outcome Measures

Primary Outcomes (2)

• Number of Participants Enrolled Requiring Emergent Healthcare (Such as Re-hospitalization, Unscheduled Physician Office Visits, Urgent Care Visits or Emergency Room Visits).

  Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on the number of participants with emergent and non-emergent healthcare utilization with sleep-disordered breathing who are hospitalized with co-morbid Chronic Obstructive Pulmonary Disease (COPD), number of participants enrolled.

  60 days post-discharge

• Composite End-point of Time (# of Days) to Occurrence of Emergent Healthcare Utilization (Such as Re-hospitalization, Unscheduled Physician Office Visits, Urgent Care Visits or Emergency Room Visits).

  Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on time to (# of days) emergent and non-emergent healthcare utilization in patients with sleep-disordered breathing who are hospitalized with co-morbid Chronic Obstructive Pulmonary Disease (COPD).

  60 days post-discharge

Secondary Outcomes (6)

• Healthcare Costs

  60 days post-discharge

• Change in Quality of Life (SF-36) at 30 and 60 Days

  30 and 60 days post-discharge

• Change in Quality of Life (FOSQ) at 30 and 60 Days

  30 and 60 days post-discharge

• Composite End-point of Time to Occurrence of Non-emergent Healthcare Utilization (Such as Scheduled Hospitalization, Scheduled Physician Office, Urgent Care Visits or Emergency Room Visits).

  6 months

• Time to Re-hospitalization Alone

  60 days post-discharge

Study Arms (2)

AVAPS-AE Non-invasive ventilation therapy

EXPERIMENTAL

Participants will be initiated on AVAPS-AE therapy (intervention arm) for 60 days. AVAPS-AE is a mode of therapy (Philips Respironics Inc, Monroeville, Pa) with potential advantages over the currently established modes of non-invasive positive pressure ventilation (CPAP and bilevel therapy). This mode of therapy incorporates AVAPS (automated adjustable Inspiratory Positive Airway Pressure (IPAP) setting to maintain target ventilation with a settable rate of change), Auto Expiratory Positive Airway Pressure (EPAP) and Auto Back up Rate.

Device: AVAPS-AE Non-invasive ventilation therapy

Standard of Care Group

NO INTERVENTION

Evaluation and treatment of the participant's sleep disordered breathing will be per their participant's health care provider's usual care pathway.

Interventions

AVAPS-AE Non-invasive ventilation therapy DEVICE

Participants will use the device greater than or equal to 4hrs per night for the 60 days after discharge.

AVAPS-AE Non-invasive ventilation therapy

Eligibility Criteria

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

You may qualify if:

• Hospitalized patients who are at high risk for readmission who are at least 18 years of age.
• Specifically patients with (a) admission diagnosis of COPD AND (b) either a prior non-elective hospitalization (One in the past 12 months) OR active smoker who are ready for discharge AND (c) are also found to have sleep-disordered breathing (AHI ≥ 10 per hour; \>3% oxygen desaturation for hypopneas) by overnight portable respiratory study prior to hospital discharge.
• Bedside spirometry revealing evidence for obstructive lung disease (post-bronchodilator; GOLD stage II or greater (FEV1 \<70% predicted post BD).
• No previous home Positive Airway Pressure (PAP) or Non- Invasive Ventilation (NIV) use within the past year

You may not qualify if:

• Central sleep apnea (Central apnea index \>5 per hour; and/or \>50% are central apneas \& hypopneas)
• Clinically unstable, i.e., Acute Respiratory Failure, hypotensive shock, uncontrolled cardiac ischemia or arrhythmias, requiring life support ventilation or as otherwise determined by the investigator
• Participants with Stage III \& IV Chronic Heart Failure as defined by the New York Heart Association (NYHA) Classification
• Known or expected contraindications for the use of non-invasive ventilation per the assessment of the investigator.
• Lack of medical insurance

Sponsors & Collaborators

• Philips Respironics: lead
• University of Arizona: collaborator

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

Related Publications (4)

• Briones Claudett KH, Briones Claudett M, Chung Sang Wong M, Nuques Martinez A, Soto Espinoza R, Montalvo M, Esquinas Rodriguez A, Gonzalez Diaz G, Grunauer Andrade M. Noninvasive mechanical ventilation with average volume assured pressure support (AVAPS) in patients with chronic obstructive pulmonary disease and hypercapnic encephalopathy. BMC Pulm Med. 2013 Mar 12;13:12. doi: 10.1186/1471-2466-13-12.

  PMID: 23497021 BACKGROUND

• Marin JM, Soriano JB, Carrizo SJ, Boldova A, Celli BR. Outcomes in patients with chronic obstructive pulmonary disease and obstructive sleep apnea: the overlap syndrome. Am J Respir Crit Care Med. 2010 Aug 1;182(3):325-31. doi: 10.1164/rccm.200912-1869OC. Epub 2010 Apr 8.

  PMID: 20378728 BACKGROUND

• Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009 Apr 2;360(14):1418-28. doi: 10.1056/NEJMsa0803563.

  PMID: 19339721 BACKGROUND

• Westert GP, Lagoe RJ, Keskimaki I, Leyland A, Murphy M. An international study of hospital readmissions and related utilization in Europe and the USA. Health Policy. 2002 Sep;61(3):269-78. doi: 10.1016/s0168-8510(01)00236-6.

  PMID: 12098520 BACKGROUND

Limitations and Caveats

Enrollment was terminated early due to a high number of screen failures therefore data analysis with any statistical significance could not be performed.

Results Point of Contact

• Title: Chuck Cain
• Organization: Philips

chuck.cain@philips.com

412-542-3605

Study Officials

• Sairam Parthasarathy, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2015
• First Posted: May 18, 2015
• Study Start: October 6, 2017
• Primary Completion: May 3, 2018
• Study Completion: May 21, 2018
• Last Updated: August 5, 2020
• Results First Posted: July 10, 2019

Record last verified: 2020-07

Locations

US (1)