The study evaluates the safety and efficacy of the modified Bi-level positive airway pressure (BiPAP) A40 with Vector Algorithm to treat Chronic Obstructive Pulmonary Disease (COPD) patients with excessive carbon dioxide in their bloodstream (hypercapnia) and expiratory flow limitation (EFL), a constriction of the lower airways. The study will include current users of non-invasive ventilation (NIV) as well as those who are not currently using an NIV device.
This study is a prospective randomized controlled cross-over pilot trial to investigate the clinical efficacy and safety of the Modified Bi-level positive airway pressure (BiPAP) A40 with Vector Algorithm (Vector Device), a non-invasive ventilation (NIV) device, to treat Chronic Obstructive Pulmonary Disease (COPD). Approximately 30 COPD patients with chronic hypercapnia and evidence of expiratory flow limitation (EFL) will be included. It is estimated that 50 patients may need to be enrolled in order to complete 30. There will be two different patient cohort groups, patients that are current users of NIV and patients that are Naïve to NIV. Only those that meet the inclusion/exclusion criteria will be screened to determine if EFL is present. If participants are found to have EFL they will undergo a 20 minute EFL abolishment determination. Those participants that have EFL and a titrated expiratory positive airway pressure (EPAP) ≥6cmH2O will be scheduled for study visit 2. During study visit 2, participants will be randomized in a 1:1 ratio to receive either standard NIV (control) or Vector (Active) for the first 4 to 6-week at-home treatment period, followed by the other treatment during the second 4 to 6 weeks. Participants will have up to 4 (NIV current Users) or 5 (NIV Naïve) in-person visits that will include 2 overnight sleep studies with polysomnogram (PSG).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
The Modified BiPAP A40 with Vector Algorithm (Vector) is intended to provide non-invasive ventilatory support to treat patients weighing over 10 kg (22 lbs) with Obstructive Sleep Apnea (OSA) or Respiratory Insufficiency. It is intended to be used within the home, institutional/ hospital, and diagnostic laboratory environments. This device is not intended for life support. The BiPAP A40 EFL screening and therapy is intended for patients weighing over 30 kg (66 lbs) with Obstructive Sleep Apnea (OSA), or Respiratory Insufficiency with primary cause being Chronic Obstructive Pulmonary Disease (COPD) to screen for the presence, and abolishment of Expiratory Flow Limitation (EFL).
The Modified BiPAP A40 with Standard of Care settings is intended to provide non-invasive ventilatory support to treat patients weighing over 10 kg (22 lbs) with Obstructive Sleep Apnea (OSA) or Respiratory Insufficiency. It is intended to be used within the home, institutional/ hospital, and diagnostic laboratory environments. This device is not intended for life support. The BiPAP A40 EFL screening and therapy is intended for patients weighing over 30 kg (66 lbs) with Obstructive Sleep Apnea (OSA), or Respiratory Insufficiency with primary cause being Chronic Obstructive Pulmonary Disease (COPD) to screen for the presence, and abolishment of Expiratory Flow Limitation (EFL).
Temple University Hospital
Philadelphia, Pennsylvania, United States
Daytime PaCO2 (Arterial Blood Gas)
Room air CO2 levels at the end of 4-6 weeks of therapy as determined by Arterial Blood Gas (PaCO2)
Time frame: At the end of the 4-to-6-week period
Average 30 Day Ventilator Usage Hours
How many hours per night over 30 days that the participant uses the device.
Time frame: Up to 30 days of device use
Patient Comfort and Therapy Preference Based Questionnaire Responses
Comfort data from device satisfaction/preference questionnaire after 30 days of device use. The specific question analyzed was " Which ventilator pressure settings or therapy did you prefer?" Outcome was number of participants who selected each therapy as preferred.
Time frame: Up to 30 days of device use
Unanticipated Serious Adverse Device Effects (USADEs) and Serious Adverse Events (SAEs) Assessment
Incidence of Unanticipated Serious Adverse Device Effects (USADEs) and Serious Adverse Events (SAEs) for the Vector vs. the control group.
Time frame: Up to 30 days of device use
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