Vector Engineering Clinical
Completed · Not applicable
Conditions studied: COPD
In brief
This study aimed to validate a novel automatic non-invasive ventilation (NIV) mode that continuously adjusts expiratory positive airway pressure (EPAP) to the lowest value that abolishes tidal expiratory flow limitation (EFL). The investigator conducted a prospective, non-randomized, study on stable chronic obstructive pulmonary disease (COPD) patients that may or may not be treated currently with NIV. Patients were studied in a sleep lab on a single night with the auto - titrating EPAP that adjusts to abolish tidal EFL. The primary endpoint was to evaluate the behavior of the EPAP during the night. Additionally, a sub-group of patients used the device at home for a 2 week period. EPAP behavior was assessed during this 2 week period.
Key facts
- Study ID
- NCT04725500
- Run by
- Philips Clinical & Medical Affairs Global
- People needed
- 42
- Starts
- 2018-10-04
- Expected to finish
- 2020-03-03
- Last updated by the study team
- 2021-05-26
Who can join
Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age > 40 years of age; < 80 years of age
- Ability to provide consent
- Diagnosis of COPD
- Must present with EFL via screening of the vector device at 3 cmH2O
- Have an EPAP to abolish EFL greater or equal to 6cmH2O
- Must be able to maintain SpO2 greater than 88% at rest and during EPAP Titration
- Participants who completed the initial study and who would be willing to use the Vector NIV device at home during the night for a 2 week period OR
- Participants prescribed and currently using a PAP or NIV device at home who meet study inclusion/exclusion criteria of primary protocol
You may not qualify if…
- 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
- Suffering from a COPD exacerbation at the time of data collection or in the 30 days prior to data collection
- Self-reported Pregnancy
- Employee or family member that is affiliated with Philips Respironics
- Currently employed by a manufacturer of respiratory products or family member employed by a manufacturer of respiratory products
- History of bullous emphysema
- History of pneumothorax
- Evidence of acute sinusitis or otitis media
- Hypotension
- Participants at risk for aspiration of gastric contents
- Epistaxis
- Participants in respiratory failure
- Inability to maintain a patent airway or adequately clear secretions
- Participants currently using a PAP or NIV device at home with a documented EPAP setting on their current device that is greater than then the mean or final EPAP determined during the therapy session of the screening visit.
Where it is running
- Pulmonary Rehabilitation Associates — Youngstown, Ohio, United States
- Jefferson Associates and Internal Medicine — Clairton, Pennsylvania, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.