NCT04263532

Vector Efficacy Cross-Over Pilot Study

Randomized Controlled Cross-Over Pilot Study of the Effectiveness of the Vector NIV Device in Hypercapnic COPD Patients With Expiratory Flow Limitation

• Status: Terminated
• Phase: —
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Philips Clinical & Medical Affairs Global · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DEVICE	Modified BiPAP A40 with Vector Algorithm (Vector)	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).
DEVICE	Modified BiPAP A40 with Standard of Care Settings	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).

Timeline

• Start date: 2020-01-21
• Primary completion: 2023-11-17
• Completion: 2023-11-17
• First posted: 2020-02-10
• Last updated: 2025-05-09
• Results posted: 2025-05-09

Locations

1 site across 1 country: United States