Chronic Obstructive Pulmonary DiseaseNCT03851510
Determination of the Prevalence and Severity of Expiratory Flow Limitation in Chronic Obstructive Pulmonary Disease Patients
A study testing Vector ventilator and Resmon Pro in people with Chronic Obstructive Pulmonary Disease and Noninvasive Ventilation, run by Philips Respironics at 1 site in United States.
Trial summary
Expiratory Flow Limitation (EFL) occurs when the airways become compressed, which usually results when the pressure outside the airway exceeds the pressure inside the airway. EFL can be detected using the Forced Oscillation Technique (FOT), which has been incorporated into a new screening feature in the Philips… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Noninvasive Ventilation
- What is being tested?
- Vector ventilator and Resmon Pro
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2019to 15 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 40 years of age; < 80 years of age
- Ability to provide consent
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
Who cannot join
- 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
- History of bullous emphysema
- History of pneumothorax
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida, Jacksonville
Jacksonville, Florida, 32209
About this study
Expiratory Flow Limitation (EFL) occurs when the airways become compressed, which usually results when the pressure outside the airway exceeds the pressure inside the airway. EFL can be detected using the Forced Oscillation Technique (FOT), which has been incorporated into a new screening feature in the Philips Respironics BiPAP Ventilator overall platform (Vector Non-Invasive (NIV) device). In this study, the Vector device will be used in a cross-sectional non-randomized epidemiology study to assess the prevalence and severity of expiratory flow limitation in a community COPD population. The study will also investigate how the presence of EFL may correlate with other physiological biomarker endpoints in the COPD patient. Participants will include 100 male and females with a diagnosis of COPD between the ages of 40 and 80. During the one-visit study, participants will undergo an EFL screening using the Vector device. If EFL is not detected during the screening after 5 minutes, the participant will not continue. If EFL is detected by the device, the participant will continue to wear it while it measures the level of therapy that is needed to eliminate EFL. Twenty minutes of pressure therapy will then be provided and the final Expiratory Positive Airway Pressure (EPAP) that is determined to abolish the participants EFL will be recorded. Participant characteristics (e.g. health history, behaviors, anthropometric, vitals, etc.) will be also be collected via questionnaires, medical record review, and physical exam. Future benefits of the study will be to gain a better understanding of the Vector screening feature and the characteristics of patients who present with varying degrees of EFL severity.
Read the detailed description
This will be a cross-sectional, non-randomized epidemiology study designed to assess the prevalence and severity of expiratory flow limitation in a community COPD population. In the study we will also investigate how the presence EFL may correlate to other physiological biomarker endpoints in the COPD patient.
Schedule of Events:
Study Visit
- Once the participant arrives, the study will be explained in full detail. If the participant agrees, he/she will be consented into the study and the participant will be given a copy of the informed consent.
- Once consent is obtained, and eligibility is confirmed the following study related procedures will be conducted:
- Demographics: gender, date of birth, ethnicity, race, level of education will be collected.
- Current Medications: all current medications will be collected.
- Medical History Assessment: information will be collected regarding historical spirometry data, COPD history and other relevant medical history including the diagnosis of Sleep disordered breathing and Oxygen therapy usage. Chest computerized tomography (CT) scans will be collected if they have not been done within the past two years. A new CT scan will not be required.
- Physical examination with anthropometric data (weight, height and temperature) collected and vital signs to include Heart Rate (HR),Blood Pressure (BP), Respiratory Rate (RR), and Oxygen Saturation (SPO2) maintained at least 88% on room air, and chest auscultation.
- Review of inclusion/exclusion to ensure participant is eligible to continue
- Administration of Study Questionnaires
- Mask Fitting: Participants will have up to two mask fittings in order to determine the best possible masks while using the Vector NIV device during the EFL screening and titration.
- Spirometry testing will be performed for participants who have not had a test in the previous 6 months Resmon Pro EFL Measurement
- Participants will be required to wear nose clips during the measurement
- Participants will also be required to hold their cheeks during the measurement to prevent any air leaks around their mouth.
- While seated, participants will be instructed to breathe normally into the device for at least 30 seconds or until at least 10 breaths were successfully accepted by the device
- Participants will be asked to repeat test while in the supine or semi-recumbent position.
Vector EFL Screening/Determination and EPAP Titration
- EFL Determination: The participant will be asked to breathe quietly into the Vector device using the selected mask for 5 minutes in the seated position, and then an additional 5 minutes while in supine or semi-recumbent position. This device has the capability of detecting EFL. If it is determined that the participant does not have EFL by the device screening indicator, the participant will not continue with the EPAP titration.
- EPAP Titration: if it is determined by the Vector NIV device that the participant has EFL, the Vector NIV device will be changed from screening mode to therapy mode to delivery BiPAP therapy with the following settings.
Vector Device Settings:
- Pressure Support 6 cmH2O
- Max Pressure 26 cmH2O
- EPAP Min / EPAP Max 4 / 20 cmH2O
- The participants will then breathe on the Vector NIV device in the supine position (preferred) or semi-recumbent if needed for approximately an additional 20 minutes. During the additional 20 minutes of breathing, the device will automatically increase the EPAP (and concurrently and proportionally the IPAP) until the EFL is abolished (or falls below the predetermined EFL threshold).
- While the automatic EPAP Titration is being performed, all participants' SpO2 will be monitored via finger pulse oximetry.
- Patient must stay awake during the EPAP Titration. If the patient falls asleep, they will be woken by study staff.
- The Final EPAP that is determined to abolish the participants EFL will be recorded
- Participants will complete an EFL Vector device post questionnaire
- Being tested
- Vector ventilator, Resmon Pro
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vector ventilatorDevice
The Vector ventilator is intended to provide non-invasive ventilatory support to treat adult patients with Obstructive Sleep Apnea (OSA), or Respiratory Insufficiency with the primary cause being COPD. This device is not intended for life support. It may be used to screened for the presence and abolishment of expiratory flow limitation. It is intended to be used within the home, institution/hospital, and diagnostic laboratory environments. The vector ventilator will titrate and treat EFL using non-invasive ventilatory support.
Resmon ProDevice
The Resmon Pro uses the forced oscillation technique (FOT) which is a noninvasive method to measure the mechanical properties of the lung and airways during tidal breathing. In addition to measuring total impedance (resistance and reactance), the Resmon Pro can measure expiratory flow limitation which is a key index of respiratory obstruction
| Study group | Role | What they receive |
|---|---|---|
| Resmon Pro | Active comparator | COPD participants will be first screened for Expiratory Flow Limitation using the Resmon Pro. Receives: Device: Resmon Pro |
| Vector Ventilator | Experimental | COPD participants will be screened again for Expiratory Flow Limitation using the Vector device, participants with EFL will undergo 20 minute titration protocol for therapy. Receives: Device: Vector ventilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Prevalence of Expiratory Flow Limitation
The overall prevalence of EFL will be determined. This is defined as the percentage of participants exhibiting a DeltaXRS value greater than or equal to 2.8 using the Vector EFL device while supine. For purposes of this trial, overall prevalence includes indeterminate EFL and EFL.
Measured: 1 day
Secondary outcomes (3)
Correlation of Titrated Final EPAP to Participants' Forced Expiratory Volume in One Second (FEV1)
Correlation of titrated final EPAP (EPAP that is determined to abolish EFL) to patients' Forced Expiratory Volume in one second (FEV1).
Measured: 1 day
Correlation of Titrated Final EPAP to Participants' Screening DeltaXrs Value
Correlation of titrated final EPAP (EPAP that is determined to abolish EFL) to participants screening DeltaXrs value
Measured: 1 day
Percent of Participants With EFL Per the Resmon Pro That Have Their EFL Abolished During the Vector Screening.
Percent of participants with EFL per the Resmon Pro that have their EFL abolished during the Vector screening. This will be calculated by the number of participants screened positive for EFL with the Resmon Pro who screened negative for EFL with the Vector device.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start14 Mar 2019
- Primary completion15 Nov 2023
- Study completion15 Nov 2023
Why it stopped: Study discontinued due to shifted business priorities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Participants are first getting screened with Resmon Pro they then will be screened with the Vector ventilator for EFL. Those that screen positive with EFL with the Vector ventilator will be treated with the vector device with a 20 minute titration protocol.
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Respironics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851510
- Sponsor's protocol ID
- VectorEFLScreening-2018-10242
- Status last verified
- Oct 2024
- First submitted
- 15 Feb 2019
- Last updated
- 24 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Prevalence and Severity of Expiratory Flow Limitation in Chronic Obstructive Pulmonary Disease Patients
- ClinicalTrials.gov ID
- NCT03851510
- Acronym / sponsor ID
- VectorEFLScreening-2018-10242
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study discontinued due to shifted business priorities.
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Philips RespironicsIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 22 Feb 2019 (actual)
- Results
- Posted 24 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Expiratory Flow Limitation (EFL) occurs when the airways become compressed, which usually results when the pressure outside the airway exceeds the pressure inside the airway. EFL can be detected using the Forced Oscillation Technique (FOT), which has been incorporated into a new screening feature in the Philips Respironics BiPAP Ventilator overall platform (Vector Non-Invasive (NIV) device). In this study, the Vector device will be used in a cross-sectional non-randomized epidemiology study to assess the prevalence and severity of expiratory flow limitation in a community COPD population. The study will also investigate how the presence of EFL may correlate with other physiological biomarker endpoints in the COPD patient. Participants will include 100 male and females with a diagnosis of COPD between the ages of 40 and 80. During the one-visit study, participants will undergo an EFL screening using the Vector device. If EFL is not detected during the screening after 5 minutes, the participant will not continue. If EFL is detected by the device, the participant will continue to wear it while it measures the level of therapy that is needed to eliminate EFL. Twenty minutes of pressure therapy will then be provided and the final Expiratory Positive Airway Pressure (EPAP) that is determined to abolish the participants EFL will be recorded. Participant characteristics (e.g. health history, behaviors, anthropometric, vitals, etc.) will be also be collected via questionnaires, medical record review, and physical exam. Future benefits of the study will be to gain a better understanding of the Vector screening feature and the characteristics of patients who present with varying degrees of EFL severity.
Detailed description
This will be a cross-sectional, non-randomized epidemiology study designed to assess the prevalence and severity of expiratory flow limitation in a community COPD population. In the study we will also investigate how the presence EFL may correlate to other physiological biomarker endpoints in the COPD patient.
Schedule of Events:
Study Visit
- Once the participant arrives, the study will be explained in full detail. If the participant agrees, he/she will be consented into the study and the participant will be given a copy of the informed consent.
- Once consent is obtained, and eligibility is confirmed the following study related procedures will be conducted:
- Demographics: gender, date of birth, ethnicity, race, level of education will be collected.
- Current Medications: all current medications will be collected.
- Medical History Assessment: information will be collected regarding historical spirometry data, COPD history and other relevant medical history including the diagnosis of Sleep disordered breathing and Oxygen therapy usage. Chest computerized tomography (CT) scans will be collected if they have not been done within the past two years. A new CT scan will not be required.
- Physical examination with anthropometric data (weight, height and temperature) collected and vital signs to include Heart Rate (HR),Blood Pressure (BP), Respiratory Rate (RR), and Oxygen Saturation (SPO2) maintained at least 88% on room air, and chest auscultation.
- Review of inclusion/exclusion to ensure participant is eligible to continue
- Administration of Study Questionnaires
- Mask Fitting: Participants will have up to two mask fittings in order to determine the best possible masks while using the Vector NIV device during the EFL screening and titration.
- Spirometry testing will be performed for participants who have not had a test in the previous 6 months Resmon Pro EFL Measurement
- Participants will be required to wear nose clips during the measurement
- Participants will also be required to hold their cheeks during the measurement to prevent any air leaks around their mouth.
- While seated, participants will be instructed to breathe normally into the device for at least 30 seconds or until at least 10 breaths were successfully accepted by the device
- Participants will be asked to repeat test while in the supine or semi-recumbent position.
Vector EFL Screening/Determination and EPAP Titration
- EFL Determination: The participant will be asked to breathe quietly into the Vector device using the selected mask for 5 minutes in the seated position, and then an additional 5 minutes while in supine or semi-recumbent position. This device has the capability of detecting EFL. If it is determined that the participant does not have EFL by the device screening indicator, the participant will not continue with the EPAP titration.
- EPAP Titration: if it is determined by the Vector NIV device that the participant has EFL, the Vector NIV device will be changed from screening mode to therapy mode to delivery BiPAP therapy with the following settings.
Vector Device Settings:
- Pressure Support 6 cmH2O
- Max Pressure 26 cmH2O
- EPAP Min / EPAP Max 4 / 20 cmH2O
- The participants will then breathe on the Vector NIV device in the supine position (preferred) or semi-recumbent if needed for approximately an additional 20 minutes. During the additional 20 minutes of breathing, the device will automatically increase the EPAP (and concurrently and proportionally the IPAP) until the EFL is abolished (or falls below the predetermined EFL threshold).
- While the automatic EPAP Titration is being performed, all participants' SpO2 will be monitored via finger pulse oximetry.
- Patient must stay awake during the EPAP Titration. If the patient falls asleep, they will be woken by study staff.
- The Final EPAP that is determined to abolish the participants EFL will be recorded
- Participants will complete an EFL Vector device post questionnaire
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are first getting screened with Resmon Pro they then will be screened with the Vector ventilator for EFL. Those that screen positive with EFL with the Vector ventilator will be treated with the vector device with a 20 minute titration protocol.
| Arm | Type | Receives |
|---|---|---|
| Resmon Pro | Active comparator | Device: Resmon ProCOPD participants will be first screened for Expiratory Flow Limitation using the Resmon Pro. |
| Vector Ventilator | Experimental | Device: Vector ventilatorCOPD participants will be screened again for Expiratory Flow Limitation using the Vector device, participants with EFL will undergo 20 minute titration protocol for therapy. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 40 years of age; < 80 years of age
- Ability to provide consent
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vector ventilatorThe Vector ventilator is intended to provide non-invasive ventilatory support to treat adult patients with Obstructive Sleep Apnea (OSA), or Respiratory Insufficiency with the primary cause being COPD. This device is not intended for life support. It may be used to screened for the presence and abolishment of expiratory flow limitation. It is intended to be used within the home, institution/hospital, and diagnostic laboratory environments. The vector ventilator will titrate and treat EFL using non-invasive ventilatory support. | Device | Vector Ventilator |
| Resmon ProThe Resmon Pro uses the forced oscillation technique (FOT) which is a noninvasive method to measure the mechanical properties of the lung and airways during tidal breathing. In addition to measuring total impedance (resistance and reactance), the Resmon Pro can measure expiratory flow limitation which is a key index of respiratory obstruction | Device | Resmon Pro |
Primary outcome
Overall Prevalence of Expiratory Flow Limitation
Time frame: 1 day
The overall prevalence of EFL will be determined. This is defined as the percentage of participants exhibiting a DeltaXRS value greater than or equal to 2.8 using the Vector EFL device while supine. For purposes of this trial, overall prevalence includes indeterminate EFL and EFL.
3 secondary outcomes
Correlation of Titrated Final EPAP to Participants' Forced Expiratory Volume in One Second (FEV1)
Time frame: 1 day
Correlation of Titrated Final EPAP to Participants' Screening DeltaXrs Value
Time frame: 1 day
Percent of Participants With EFL Per the Resmon Pro That Have Their EFL Abolished During the Vector Screening.
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vector ventilator and Resmon Pro in people with Chronic Obstructive Pulmonary Disease and Noninvasive Ventilation, run by Philips Respironics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Prevalence of Expiratory Flow Limitation (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.