Vector Engineering Clinical

Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Device: Auto-Titrating EPAP

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Youngstown, Ohio, United States, 44512
      • Pulmonary Rehabilitation Associates
  • Pennsylvania
    • Clairton, Pennsylvania, United States, 15025
      • Jefferson Associates and Internal Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Auto-titrating EPAP; ExpiraFlowTM technology- Non-invasive ventilator that auto titrates EPAP to abolish Expiratory flow limitation.	Device: Auto-Titrating EPAP; In the Auto-titrating EPAP mode, the device automatically adjusted EPAP to the minimum level able to abolish tidal expiratory flow limitation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average EPAP During Overnight PSG	The expiratory positive airway pressure (EPAP) is the parameter that is automatically adjusted. The ventilator automatically titrates EPAP to the minimum value able to abolish expiratory flow limitation.	Approximately 8 hours
Difference Between Mean Inspiratory and Expiratory Reactance During Overnight PSG	The difference between mean inspiratory and expiratory reactance is measured using the forced oscillation technique. The difference between mean inspiratory and expiratory reactance is an index of tidal expiratory flow limitation. Values > 2.8 cmH2O*s/L are indicative of tidal expiratory flow limitation.	Approximately 8 hours
Average EPAP for 2 Week Device Take Home Studies	The expiratory positive airway pressure (EPAP) is the parameter that is automatically adjusted. The ventilator automatically titrates EPAP to the minimum value able to abolish expiratory flow limitation.	Approximately 8 hours nightly use over 14 days
Difference Between Mean Inspiratory and Expiatory Reactance During 2 Week Device Take Home Studies	The difference between mean inspiratory and expiatory reactance is measured using the forced oscillation technique. The difference between mean inspiratory and expiratory reactance is an index of tidal expiratory flow limitation. Values > 2.8 cmH2O*s/L are indicative of tidal expiratory flow limitation.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Quality	Sleep quality is a key outcome during overnight studies. Nocturnal non-invasive ventilation may affect sleep quality in two ways: 1) it may improve it by reducing sleep-related respiratory problems; 2) it may worsen it if the ventilation mode causes discomfort to the patient. Sleep quality was evaluated by full laboratory polysomnography. Participants after there overnight answered a question of comfort and they answered as 1- being very uncomfortable 2- uncomfortable 3- neutral 4- comfortable 5- very comfortable.	Approximately 8 hours
2 Week Home Use Device Compliance	Device usage every day, for 14 days based on data downloaded from the device.	Nightly use for 14 days
Therapy Comfort Survey	Prior NIV users rated their comfort with the Forced Oscillation Technique (FOT) therapy over their prior non-invasive ventilation (NIV) therapy. Participants were asked the question "how comfortable did the pressure therapy feel compared to your current device" and they answered the questions on a scale of 0 to 5. 5-Very Comfortable 4-Comfortable 3-Neutral 2-Uncomfortable 1-Very Uncomfortable 0-Not applicable	End of 2 weeks device take home study

Collaborators and Investigators

• Sponsor: Philips Clinical & Medical Affairs Global

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2018
• Primary Completion (Actual): March 3, 2020
• Study Completion (Actual): March 3, 2020

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (Actual): January 26, 2021

Study Record Updates

• Last Update Posted (Actual): May 26, 2021
• Last Update Submitted That Met QC Criteria: May 25, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Non Invasive Ventilation; Expiratory Flow Limitation
• Other Study ID Numbers: SRC-HRC-VectorENG -2018-10241

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes