Vector Engineering Clinical

NCT04725500 | Completed Results FDA Device

• 1 other identifier: SRC-HRC-VectorENG -2018-10241
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

COPD

Keywords

Non Invasive Ventilation; Expiratory Flow Limitation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Sleep Quality

  Approximately 8 hours

• 2 Week Home Use Device Compliance

  Nightly use for 14 days

• Therapy Comfort Survey

  End of 2 weeks device take home study

Study Arms (1)

Auto-titrating EPAP

EXPERIMENTAL

ExpiraFlowTM technology- Non-invasive ventilator that auto titrates EPAP to abolish Expiratory flow limitation.

Device: Auto-Titrating EPAP

Interventions

Auto-Titrating EPAP DEVICE

In the Auto-titrating EPAP mode, the device automatically adjusted EPAP to the minimum level able to abolish tidal expiratory flow limitation.

Auto-titrating EPAP

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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.

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (2)

Pulmonary Rehabilitation Associates

Youngstown, Ohio, 44512, United States

Location

Jefferson Associates and Internal Medicine

Clairton, Pennsylvania, 15025, United States

Location

Related Publications (1)

• 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.

  PMID: 34949190 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chuck Cain
• Organization: Philips

chuck.cain@philips.com

412-657-1814

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 26, 2021
• Study Start: October 4, 2018
• Primary Completion: March 3, 2020
• Study Completion: March 3, 2020
• Last Updated: May 26, 2021
• Results First Posted: April 6, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)