Vector Engineering Clinical

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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COPD

Intervention / Treatment
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* Device: Auto-Titrating EPAP


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non Invasive Ventilation, Expiratory Flow Limitation