Vector Efficacy Cross-Over Pilot Study
Megadott ok: Study discontinued due to shifted business priorities.
Key facts
- Where
- Philadelphia, Egyesült ÁllamokSee the site
Where in Egyesült Államok
- Temple University HospitalPhiladelphia, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Philips Clinical & Medical Affairs Global
- Trial code
- NCT04263532
- Record updated
- 2025. május 9.
- Original description
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.Read full original descriptionShow less
Randomized Controlled Cross-Over Pilot Study of the Effectiveness of the Vector NIV Device in Hypercapnic COPD Patients With Expiratory Flow Limitation
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.
Inclusion: Age greater than or equal to 40 years of age; less than or equal to 80 years of age; Ability to provide consent; Chronic obstructive pulmonary disease (COPD) patients with hypercapnia (as defined as greater than or equal to 52mmHg) who are either current non-invasive ventilation (NIV) users or naïve to NIV; On average, use NIV more than 4 hours per night (Current NIV users); Must present with expiratory flow limitation (EFL) via screening of the Vector device at 3 cmH2O; Have an EPAP to abolish EFL greater or equal to 6cmH2O.
Exclusion: Suffering from a COPD exacerbation (Defined as hospital admission, ER/urgent care visit, MD visit with medication change or other intervention deemed to be clinically significant by the investigator at the time of data collection or in the 14 days prior to data collection; Participants currently using a PAP or NIV device at home with a documented EPAP setting on their current device that is greater than the calculated EPAP determined during the therapy session of the screening visit (Current NIV Users); Recent cranial surgery (i.e, less than 1 year); Recent upper airway or GI surgery within the past 6 months; Any major non-COPD uncontrolled disease or condition, such as congestive heart failure, malignancy, liver or renal insufficiency (that requires current evaluation for liver or renal transplantation or dialysis), amyotrophic lateral sclerosis, or severe stroke, or other condition as deemed appropriate by investigator as determined by review of medical history and / or participant reported medical history; Any history of giant bulla (size >1/3 hemi-thorax); History of pneumothorax < 6 months; Existing respiratory failure; Self-reported Pregnancy or positive pregnancy test for women of childbearing potential; Employee or family member that is affiliated with Philips; Currently employed by a manufacturer of respiratory products or family member employed by a manufacturer of respiratory products; Life expectancy ≤12 months as determined by clinical investigator; Low BP: Systolic <90; Impaired swallowing as reported by participant or diagnostic exam; Unable to be fitted with mask; Excessive secretions as reported by clinical investigator/physician assessment, inability to maintain a patent airway or adequately clear secretions, or at risk for aspiration of gastric contents; Diagnosed with acute sinusitis or otitis media; Epistaxis, causing pulmonary aspiration of blood; Participants who are naïve to NIV (Cohort 2) that use the device fewer than 3 out of 7 nights during the second week of the 2-week acclimation period; Participants who are naïve to NIV (Cohort 2) that average less than 4 hours of device use during the second week of the 2-week acclimation period; Participants who are naïve to NIV (Cohort 2) with an average nightly 90% EPAP pressure during the second week of the 2-week acclimation period that is higher than the titrated EFL EPAP pressure determined at the screening visit.