Home COPD and Open Ventilation Evaluation (HOPE) Study
| Status: | Completed |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 40 - 100 |
| Updated: | 10/5/2018 |
| Start Date: | January 2017 |
| End Date: | June 2018 |
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.
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.
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.
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.
Inclusion Criteria:• Enrollment in the CATCH Study program
- Adults 40 years and older, as per inclusion criteria of the CATCH study
- Subjects with diagnosis of COPD (with and without chronic respiratory failure)
- Gold 3 & 4
- Ability and willingness to correctly execute and comply with study requirements
o Ability and willingness to use the Life2000 Ventilation System a minimum of 6
hours/day (24 hr period).
- Requirement of supplemental oxygen to maintain an SpO2 > 88% at rest or during
exercise
- Acceptable health status as assessed by medical history and/or physical exam
- Fluency in written and spoken English language
- Provision of written informed consent to participate in the study
Exclusion Criteria:• History of pneumothorax secondary to lung bullae
- Musculoskeletal or other non-pulmonary impairment that limits exercise tolerance
- Intolerance or unwillingness to utilize the Life2000 Ventilation System
- Women who are pregnant or nursing a child
- Presence of any condition or abnormality that in the opinion of the principal
investigator may compromise the subject's safety or the quality of the study data
We found this trial at
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