Vector Engineering Clinical

Philips

Status

Completed

Conditions

COPD

Treatments

Device: Auto-Titrating EPAP

Study type

Interventional

Funder types

Industry

Identifiers

NCT04725500

SRC-HRC-VectorENG -2018-10241

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.