Home COPD and Open Ventilation Evaluation (HOPE) Study
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Respiratory related diseases such as chronic obstructive pulmonary disease (COPD) and
      neuromuscular diseases remain a major public health issue affecting millions of people
      worldwide. More than 15 million people are estimated to be diagnosed with COPD in the US
      alone. In the US, the direct and indirect costs associated with COPD are estimated to be
      about $50 billion. Clinical studies have shown that by providing ventilation to reduce
      respiratory insufficiency symptoms such as dyspnea, patients may become more tolerant to
      exercise and be able to increase their participation in activities of daily living resulting
      in an overall positive impact in their quality of lives. The Life2000 Ventilation System,
      with the smallest tubing and comfortable interface solutions, is the only ventilator to
      simultaneously provide full ventilatory support and enable patients to ambulate.

      The Life2000 Ventilation System is an FDA-cleared critical care ventilator (K141943/S003,
      June 2015) indicated for use for adult patients who require positive pressure ventilation
      delivered invasively or non-invasively. The device, classified by FDA as a continuous
      ventilator, can treat both acute and chronic respiratory failure and is suitable for use in
      home and institutional settings by qualified, trained personnel under the direction of a
      physician.

      The Life2000 Compressor is intended to provide a 50-psi pressure source to the ventilator and
      is currently in the FDA premarket notification (510 k) clearance process, so its use is
      considered investigational.
    

Detailed description: 
      This will be a single-center, open-label, pilot study in 10 stable COPD subjects to assess
      the ventilatory efficacy of the Life2000 Ventilation System, as compared to a control group.
      Other important secondary endpoints as listed in this document will also be measured and
      reported. Prospective participants are all current participants in the ongoing CATCH program
      study. Subjects will be randomized to either continued monitoring alone or monitoring with
      the use of the Life2000 Ventilation System for a period of six months.

      Initial BODE Index (BMI, airway Obstruction, Dyspnea, Exercise intolerance), CO2 (carbon
      dioxide) measurements, and questionnaires and surveys are captured prior to therapy
      initiation. Thereafter, subjects will be randomly assigned to the Life2000 Ventilation System
      or their routine plan of care, as determined previously by the CATCH program, and followed
      for a period of six months. Both end tidal CO2 readings and the Physical Activity Scale for
      the Elderly (PASE) results will be captured at pre-assigned intervals during the study.
      Monthly phone assessments will be conducted with the subjects to track progress. An
      additional BODE Index measurement will be taken at Day 90, the study mid-point. At the end of
      six months, all baseline procedures and questionnaires will be repeated and the subject will
      be discharged from the study.
    

Intervention name(s): Ventilation
Intervention type(s): Device
Intervention description(s): monitoring with the use of the Life2000 Ventilation System for a period of six months
Other intervention name(s): Ambulatory
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Outpatient ventilator support