COPD
Conditions
Keywords
Non Invasive Ventilation, Expiratory Flow Limitation
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.
Interventions
DEVICEAuto-Titrating EPAP
In the Auto-titrating EPAP mode, the device automatically adjusted EPAP to the minimum level able to abolish tidal expiratory flow limitation.
Sponsors
Philips Clinical & Medical Affairs Global
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age \> 40 years of age; \< 80 years of age 2. Ability to provide consent 3. Diagnosis of COPD 4. Must present with EFL via screening of the vector device at 3 cmH2O 5. Have an EPAP to abolish EFL greater or equal to 6cmH2O 6. Must be able to maintain SpO2 greater than 88% at rest and during EPAP Titration 7. 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 8. Participants prescribed and currently using a PAP or NIV device at home who meet study inclusion/
Exclusion criteria
of primary protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 42 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 2 Week Take Home | Screen Fail | 5 |
| Screening | Screen Failure | 26 |
| Screening | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Auto-titrating EPAP |
|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 7 |
| Body Mass Index | 29.4 kg/m^2 STANDARD_DEVIATION 7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Forced Expiratory Volume in one second / Forced Vital Capacity | 55.2 percentage STANDARD_DEVIATION 16.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 42 Participants |
| Region of Enrollment United States | 42 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 42 |
| other Total, other adverse events | 3 / 42 |
| serious Total, serious adverse events | 1 / 42 |
Outcome results
Primary
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.
Time frame: Approximately 8 hours
Population: PSG data was not available for one participant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auto-titrating EPAP | Average EPAP During Overnight PSG | 9.5 cmH2O | Standard Deviation 5.4 |
Primary
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.
Time frame: Approximately 8 hours nightly use over 14 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auto-titrating EPAP | Average EPAP for 2 Week Device Take Home Studies | 6.4 cm H2O | Standard Deviation 1.3 |
Primary
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.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auto-titrating EPAP | Difference Between Mean Inspiratory and Expiatory Reactance During 2 Week Device Take Home Studies | 2.25 cmH20/L/s | Standard Deviation 0.9 |
Primary
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.
Time frame: Approximately 8 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auto-titrating EPAP | Difference Between Mean Inspiratory and Expiratory Reactance During Overnight PSG | 2.7 cmH20/L/s | Standard Deviation 5.4 |
Secondary
2 Week Home Use Device Compliance
Device usage every day, for 14 days based on data downloaded from the device.
Time frame: Nightly use for 14 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auto-titrating EPAP | 2 Week Home Use Device Compliance | 7.2 hours of therapy per night | Standard Deviation 4.3 |
Secondary
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.
Time frame: Approximately 8 hours
Population: 2 participants completed a different version of the questionnaire. 1 participant did not morning assessment.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Auto-titrating EPAP | Sleep Quality | Comfortable | 2 Participants |
| Auto-titrating EPAP | Sleep Quality | Very Comfortable | 5 Participants |
Secondary
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
Time frame: End of 2 weeks device take home study
Population: 2 participants did not complete final assessment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Auto-titrating EPAP | Therapy Comfort Survey | Not Applicable | 4 Participants |
| Auto-titrating EPAP | Therapy Comfort Survey | Uncomfortable | 1 Participants |
| Auto-titrating EPAP | Therapy Comfort Survey | Very Comfortable | 3 Participants |