Vector Engineering Clinical

Not Applicable

Completed

Conditions: COPD

Interventions: Device: Auto-Titrating EPAP

Registration Number: NCT04725500

Lead Sponsor: Philips Clinical & Medical Affairs Global

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 42

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Auto-titrating EPAP	Auto-Titrating EPAP	ExpiraFlowTM technology- Non-invasive ventilator that auto titrates EPAP to abolish Expiratory flow limitation.

Primary Outcome Measures

Name	Time	Method
Average EPAP During Overnight PSG	Approximately 8 hours	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.
Difference Between Mean Inspiratory and Expiratory Reactance During Overnight PSG	Approximately 8 hours	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.
Average EPAP for 2 Week Device Take Home Studies	Approximately 8 hours nightly use over 14 days	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.
Difference Between Mean Inspiratory and Expiatory Reactance During 2 Week Device Take Home Studies	2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Sleep Quality	Approximately 8 hours	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.
2 Week Home Use Device Compliance	Nightly use for 14 days	Device usage every day, for 14 days based on data downloaded from the device.
Therapy Comfort Survey	End of 2 weeks device take home study	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

Trial Locations

Locations (2): Pulmonary Rehabilitation Associates
🇺🇸
Youngstown, Ohio, United States
Jefferson Associates and Internal Medicine
🇺🇸
Clairton, Pennsylvania, United States