Status:
COMPLETED
Vector Engineering Clinical
Lead Sponsor:
Philips Clinical & Medical Affairs Global
Conditions:
COPD
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
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 expirat...
Detailed Description
Tidal Expiratory Flow Limitation (EFLT) is the inability to increase expiratory flow despite increasing effort. Especially in patients with mild to severe COPD, EFL can present challenges when receivi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
October 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2020
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04725500
Start Date
October 4 2018
End Date
March 3 2020
Last Update
May 26 2021
Active Locations (2)
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1
Pulmonary Rehabilitation Associates
Youngstown, Ohio, United States, 44512
2
Jefferson Associates and Internal Medicine
Clairton, Pennsylvania, United States, 15025