Clinical trial NCT04725500: Vector Engineering Clinical
Official title: Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: Non Invasive Ventilation
Expiratory Flow Limitation
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2021-01-26
Enrollment: 42
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 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.

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 receiving mechanical ventilation. To overcome EFLT expiratory positive airway pressure (EPAP) is applied; however, a single level or fixed EPAP may not overcome the airflow obstruction. The current study was undertaken to explore the variability of EFLT determined using Forced Oscillation Technique (FOT) to dynamically measure lung reactance (∆Xrs) and to evaluate the ability of automatically adjusted EPAP (PEEPopt) to over come EFLT overnight and over a two week period.

In this prospective non-randomized trial, an unreleased noninvasive ventilator set in an S/T mode applied continuous oscillations (5 Hz, 1 cmH2O amplitude, 2 cmH20 peak to peak). Response to the oscillations was analyzed to calculate ∆Xrs and EPAP was adjusted automatically between 4 and 20 cmH2O. A fixed pressure support of 6 cmH2O was delivered. ∆Xrs was measured sitting and supine. Participants with evidence of EFLT (∆Xrs \> 2.8) were asked to undergo overnight polysomnography (PSG) and then a sub-group of patients used the ventilator at home for two weeks. EFLT within and between participants was analyzed. EFLT behavior during PSG, the response of the device to dynamically abolish EFLT, as well as the impact of this therapy on sleep quality was studied. Objective ventilator adherence data were used to determine usage after the 2-week in-home use. Additionally, experienced NIV participants qualitatively rated therapy comfort compared to their current treatment.

Eligibility criteria: Inclusion Criteria:

1. Age \> 40 years of age; \< 80 years of age
2. Ability to provide consent
3. Diagnosis of COPD
4. Must present with EFL via screening of the vector device at 3 cmH2O
5. Have an EPAP to abolish EFL greater or equal to 6cmH2O
6. Must be able to maintain SpO2 greater than 88% at rest and during EPAP Titration
7. 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
8. Participants prescribed and currently using a PAP or NIV device at home who meet study inclusion/exclusion criteria of primary protocol

Exclusion Criteria:

1. 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
2. Suffering from a COPD exacerbation at the time of data collection or in the 30 days prior to data collection
3. Self-reported Pregnancy
4. Employee or family member that is affiliated with Philips Respironics
5. Currently employed by a manufacturer of respiratory products or family member employed by a manufacturer of respiratory products
6. History of bullous emphysema
7. History of pneumothorax
8. Evidence of acute sinusitis or otitis media
9. Hypotension
10. Participants at risk for aspiration of gastric contents
11. Epistaxis
12. Participants in respiratory failure
13. Inability to maintain a patent airway or adequately clear secretions
14. 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.

Primary outcomes:
measure: Average EPAP During Overnight PSG
timeFrame: Approximately 8 hours
measure: Difference Between Mean Inspiratory and Expiratory Reactance During Overnight PSG
timeFrame: Approximately 8 hours
measure: Average EPAP for 2 Week Device Take Home Studies
timeFrame: Approximately 8 hours nightly use over 14 days
measure: Difference Between Mean Inspiratory and Expiatory Reactance During 2 Week Device Take Home Studies
timeFrame: 2 weeks
Secondary outcomes:
measure: Sleep Quality
timeFrame: Approximately 8 hours
measure: 2 Week Home Use Device Compliance
timeFrame: Nightly use for 14 days
measure: Therapy Comfort Survey
timeFrame: End of 2 weeks device take home study
Other outcomes:
Locations:
city: Youngstown
country: United States
facility: Pulmonary Rehabilitation Associates
state: Ohio
city: Clairton
country: United States
facility: Jefferson Associates and Internal Medicine
state: Pennsylvania
Study officials:
References:
citation: McKenzie J, Nisha P, Cannon-Bailey S, Cain C, Kissel M, Stachel J, Proscyk C, Romano R, Hardy B, Calverley PMA. Overnight variation in tidal expiratory flow limitation in COPD patients and its correction: an observational study. Respir Res. 2021 Dec 23;22(1):319. doi: 10.1186/s12931-021-01913-7.