Trial Outcomes & Findings for Vector Engineering Clinical (NCT NCT04725500)

Last Updated: 2021-05-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

42 participants

Primary outcome timeframe

Approximately 8 hours

Results posted on

2021-05-26

Participant Flow

Participant milestones

Participant milestones
Measure	Auto-titrating EPAP ExpiraFlowTM technology- Non-invasive ventilator that auto titrates EPAP to abolish Expiratory flow limitation. 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.
Screening STARTED	42
Screening COMPLETED	15
Screening NOT COMPLETED	27
Overnight Polysomnography (PSG) STARTED	15
Overnight Polysomnography (PSG) COMPLETED	15
Overnight Polysomnography (PSG) NOT COMPLETED	0
2 Week Take Home STARTED	15
2 Week Take Home COMPLETED	10
2 Week Take Home NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Auto-titrating EPAP ExpiraFlowTM technology- Non-invasive ventilator that auto titrates EPAP to abolish Expiratory flow limitation. 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.
Screening Screen Failure	26
Screening Withdrawal by Subject	1
2 Week Take Home Screen Fail	5

Baseline Characteristics

Historical Spirometry data was collected not all participants had the FEV1/FVC values available.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Auto-titrating EPAP n=42 Participants ExpiraFlowTM technology- Non-invasive ventilator that auto titrates EPAP to abolish Expiratory flow limitation. 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.
Age, Continuous	67 years STANDARD_DEVIATION 7 • n=42 Participants
Sex: Female, Male Female	20 Participants n=42 Participants
Sex: Female, Male Male	22 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=42 Participants
Race (NIH/OMB) White	42 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=42 Participants
Region of Enrollment United States	42 participants n=42 Participants
Body Mass Index	29.4 kg/m^2 STANDARD_DEVIATION 7.0 • n=42 Participants
Forced Expiratory Volume in one second / Forced Vital Capacity	55.2 percentage STANDARD_DEVIATION 16.2 • n=36 Participants • Historical Spirometry data was collected not all participants had the FEV1/FVC values available.

PRIMARY outcome

Timeframe: Approximately 8 hours

Population: PSG data was not available for one participant.

Outcome measures

Outcome measures
Measure	Auto-titrating EPAP n=14 Participants ExpiraFlowTM technology- Non-invasive ventilator that auto titrates EPAP to abolish Expiratory flow limitation. 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.
Average EPAP During Overnight PSG	9.5 cmH2O Standard Deviation 5.4

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Auto-titrating EPAP n=15 Participants ExpiraFlowTM technology- Non-invasive ventilator that auto titrates EPAP to abolish Expiratory flow limitation. 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.
Difference Between Mean Inspiratory and Expiratory Reactance During Overnight PSG	2.7 cmH20/L/s Standard Deviation 5.4

PRIMARY outcome

Timeframe: Approximately 8 hours nightly use over 14 days

Outcome measures

Outcome measures
Measure	Auto-titrating EPAP n=10 Participants ExpiraFlowTM technology- Non-invasive ventilator that auto titrates EPAP to abolish Expiratory flow limitation. 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.
Average EPAP for 2 Week Device Take Home Studies	6.4 cm H2O Standard Deviation 1.3

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Auto-titrating EPAP n=10 Participants ExpiraFlowTM technology- Non-invasive ventilator that auto titrates EPAP to abolish Expiratory flow limitation. 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.
Difference Between Mean Inspiratory and Expiatory Reactance During 2 Week Device Take Home Studies	2.25 cmH20/L/s Standard Deviation 0.9

SECONDARY outcome

Timeframe: Approximately 8 hours

Population: 2 participants completed a different version of the questionnaire. 1 participant did not morning assessment.

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.

Outcome measures

Outcome measures
Measure	Auto-titrating EPAP n=7 Participants ExpiraFlowTM technology- Non-invasive ventilator that auto titrates EPAP to abolish Expiratory flow limitation. 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.
Sleep Quality Comfortable	2 Participants
Sleep Quality Very Comfortable	5 Participants

SECONDARY outcome

Timeframe: Nightly use for 14 days

Device usage every day, for 14 days based on data downloaded from the device.

Outcome measures

Outcome measures
Measure	Auto-titrating EPAP n=10 Participants ExpiraFlowTM technology- Non-invasive ventilator that auto titrates EPAP to abolish Expiratory flow limitation. 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.
2 Week Home Use Device Compliance	7.2 hours of therapy per night Standard Deviation 4.3

SECONDARY outcome

Timeframe: End of 2 weeks device take home study

Population: 2 participants did not complete final assessment

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

Outcome measures

Outcome measures
Measure	Auto-titrating EPAP n=8 Participants ExpiraFlowTM technology- Non-invasive ventilator that auto titrates EPAP to abolish Expiratory flow limitation. 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.
Therapy Comfort Survey Not Applicable	4 Participants
Therapy Comfort Survey Uncomfortable	1 Participants
Therapy Comfort Survey Very Comfortable	3 Participants

Adverse Events

Auto-titrating EPAP

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Auto-titrating EPAP n=42 participants at risk ExpiraFlowTM technology- Non-invasive ventilator that auto titrates EPAP to abolish Expiratory flow limitation. 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.
Psychiatric disorders Alcohol detox	2.4% 1/42 • Number of events 1 • Through 2 week take home

Other adverse events

Other adverse events
Measure	Auto-titrating EPAP n=42 participants at risk ExpiraFlowTM technology- Non-invasive ventilator that auto titrates EPAP to abolish Expiratory flow limitation. 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.
Immune system disorders Cold	2.4% 1/42 • Number of events 1 • Through 2 week take home
Respiratory, thoracic and mediastinal disorders Acute COPD Exacerbation	2.4% 1/42 • Number of events 1 • Through 2 week take home
Nervous system disorders Headache	2.4% 1/42 • Number of events 1 • Through 2 week take home

Additional Information

Chuck Cain

Philips

Phone: 412-657-1814

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place