Chronic Obstructive Pulmonary DiseaseNCT02680639
The Use of High Frequency Oscillations With NIV in Hypercapnic COPD Participants
A study testing BiPAP Synchrony ventilator in people with Chronic Obstructive Pulmonary Disease, run by Philips Respironics at 1 site in United States.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is a major cause of chronic morbidity and mortality throughout the world, being the fourth leading cause of death in the world. This study is designed to detect COPD participants with Expiratory Flow Limitation. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- BiPAP Synchrony ventilator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2015to 24 Aug 2016
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 21 years of age; < 85 years of age
- Participants that have been physician diagnosed (primary diagnosis) with Obstructive Airway Disease (to include:Chronic Obstructive Pulmonary Disease (COPD); Bronchiectasis; Severe Asthma); forced expiratory volume in 1 second (FEV1) < 60% FEV1/ forced vital capacity (FVC) <60%
- Arterial CO2 > 45 mmHg as determined by blood gas (PaCO2) or transcutaneous (tcCO2) >50 within the past month
- Ability to provide consent
- Participant has not used Non-Invasive Ventilation (BiPAP/CPAP) therapy in the past 8 hours
- Participant has no child bearing potential OR a negative pregnancy test in a woman of childbearing potential
Who cannot join
- Participants that have not returned to their baseline health status from an exacerbation of COPD or other pulmonary problems or have not established at least two weeks of stability at a new baseline.
- Use of antibiotics or prednisone for a COPD exacerbation within the previous 4 weeks.
- Uncontrolled Hypertension
- Participants that require greater than 3 liters of oxygen at rest
- History of cardiovascular instability, including uncontrolled ventricular arrhythmias, angina, diastolic BP > 100 mmHg and all Participants with pacemakers
- Any major non-COPD uncontrolled disease or condition, such as congestive heart failure, malignancy, end-stage heart disease, 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
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- History of pneumothorax
- Apnea Hypopnea Index (AHI) > 15 via in-home sleep study
- Excessive alcohol intake (> 6oz hard liquor, 48 oz. beer or 20 oz. wine daily), or illicit drug use by review of medical history and / or participant reported medical history
- Daily use of prescribed narcotics (greater than 30 mg morphine equivalent)
- History of Giant bullous emphysema
- A positive urine pregnancy test when screening for study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: The Use of High Frequency Oscillations With Noninvasive Ventilation (NIV) in Hypercapnic Chronic Obstructive Pulmonary Disease (COPD) Participants
Chronic Obstructive Pulmonary Disease (COPD) is a major cause of chronic morbidity and mortality throughout the world, being the fourth leading cause of death in the world.
This study is designed to detect COPD participants with Expiratory Flow Limitation. EFL occurs when the airways become compressed which usually results when a pressure outside the airway exceeds the pressure inside the airway.
Participants will undergo study eligibility procedures at visit 1. At visit 2 participants will undergo a baseline auto-EPAP (Expiratory Positive Airway Pressure) measurement. Then the order will be randomized to three different treatment methods. Between each treatment there will be at least a 10 minute washout period in order for CO2 to stabilize and return to baseline.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a major cause of chronic morbidity and mortality throughout the world, being the fourth leading cause of death in the world.
COPD is a disease that results in varying degrees of dyspnea, or shortness of breath. Spirometry is a method of diagnosing COPD with the presence of a post bronchodilator FEV1 <80% of the predicted value in combination with an FEV1 / FVC <70%. This would confirm that there is a presence of airflow limitation that is not fully reversible.
The presence of airflow limitation has been identified as one of the main causes of dyspnea in patients with chronic obstructive pulmonary disease (1). Expiratory Flow Limitation (EFL) occurs when the airways become compressed which usually results when a pressure outside the airway exceeds the pressure inside the airway. As an airflow obstruction worsens, EFL appears at much lower flows for a given lung volume and it becomes present at rest or at least develops early during exercise (2).
Early detection of EFL consisted of either invasive balloon catheterization or relatively complex plethysmographic techniques. An alternative approach, and one that will be used in this study, involves utilizing the Forced Oscillation Technique (FOT).
Alternatively High Frequency Oscillations (HFO) has shown to effectively lower CO2 levels, but traditionally require intubation or a trans tracheal catheter. Treatment with a specialized noninvasive ventilator is possible and it is proposed that therapy can be augmented by the application of an optimized EPAP to splint open the lower airways in order to increase the diffusive capabilities of the high frequency oscillations into lower alveolar regions. There are approximately 25 million hypercapnic patients with EFL that could benefit from this therapy. High frequency oscillations integrated into a specialized noninvasive ventilator has the advantages of lower cost than other solutions and significantly lower medical risks. In addition, high frequency oscillation uses lower pressures to achieve effective therapy which means less chance of barotrauma and greater patient acceptance.
This study will enroll subjects at a screening visit. Screening will include a physical exam and vital signs, pregnancy test (if applicable), questionnaires, pulse oximetry, measure of carbon dioxide levels, determination of EFL by an auto- Expiratory Positive Airway Pressure (EPAP) ventilator, and spirometry.
If the patient is eligible and tolerates the above procedures, they will be asked to complete an in home-based sleep study prior to visit 2. Alice Night One/ Alice PDX are portable home sleep testing devices that record information about breathing.
At visit 2 participants will be monitored continuously via a 3 lead EKG, oxygen saturation by pulse oximetry (SPO2), Carbon Dioxide concentration(TcCO2) monitor, RespiTrace belt and ventilator data.
During Visit 2, participants will first undergo a repeat optimal EPAP determination and then trial 3 different sessions of High Frequency Oscillation (HFO) therapy for 20 minutes with at least a 10 minute wash out period between each session to allow the participant's CO2 to stabilize or return to baseline. The order of the sessions will be randomized for each patient. Participants will be placed in a semi-recumbent position and wear a nasal CPAP mask for each session. A TcCO2 monitor patch will be placed on the skin (forehead area) to collect carbon dioxide measurements during each session. A RespiTrace belt will placed on the participants' chest wall to measure chest wall and diaphragmatic excursion during each session. A 3 lead EKG will also be used to monitor cardiac activity during each session.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- BiPAP Synchrony ventilator
- Keywords
- High-Frequency Ventilation, Biphasic Continuous Positive Airway Pressure
- 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.
BiPAP Synchrony ventilatorDevice
The BiPAP Synchrony ventilator will be used to determine Expiratory Positive Airway Pressure (EPAP). The ventilator will be used with varying pressure supports and oscillations depending on what arm of the study the participant is in.
| Study group | Role | What they receive |
|---|---|---|
| optimal EPAP determination | Active comparator | On the BiPAP Synchrony ventilator the EPAP (and IPAP) will be automatically adjusted by the ventilator to find optimal EPAP that abolishes EFL. Peak-to-Peak pressure oscillations will be set at 2.5 cmH2O (centimeters of water) Receives: Device: BiPAP Synchrony ventilator |
| Optimized EPAP w/ no peak-to-peak | Experimental | On the BiPAP Synchrony ventilator the EPAP (and IPAP) will be set at optimal pressure as determined by the Auto EPAP. Peak-to-Peak pressure oscillations will be set at 0 cmH2O (centimeters of water) Receives: Device: BiPAP Synchrony ventilator |
| Optimized EPAP w/ max peak-to-peak | Experimental | On the BiPAP Synchrony ventilator EPAP (and IPAP) will be set at optimal pressure as determined by the Auto EPAP. Peak-to-Peak pressure oscillations will be set at 5 cmH2O (centimeters of water) Receives: Device: BiPAP Synchrony ventilator |
| non-optimized EPAP w/ no peak-to-peak | Experimental | On the BiPAP Synchrony ventilator EPAP will be set at 4 cmH2O and IPAP will be set at 10 cmH2O (centimeters of water). Peak-to-Peak pressure oscillations will be set at 0 cmH2O (centimeters of water). Receives: Device: BiPAP Synchrony ventilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carbon Dioxide Levels
Transcutaneous carbon dioxide (TcCO2) monitoring is a non-invasive alternative to arterial blood sampling. Carbon Dioxide Levels will be measured for each participant as they complete each arm.
Measured: Baseline and 20 minutes
Secondary outcomes (3)
Respiratory Rate
Minute ventilation in regards to respiratory rate and volume of gas exchanged will be measured for each participant as they complete each arm.
Measured: 20 minutes
Tidal Volume
Minute ventilation in regards to volume of gas exchanged will be measured for each participant as they complete each arm.
Measured: 20 minutes
Minute Ventilation for Carbon Dioxide
Minute Ventilation in regards to the diffusion state of the lungs and carbon dioxide will be measured for each participant as they complete each arm.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study start13 Nov 2015
- Primary completion24 Aug 2016
- Study completion24 Aug 2016
Why it stopped: Study had a high screen fail rate, enrollment was open over a year, only 3 completed.
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
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Respironics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Pittsburgh Medical Center
- Responsible party
- Sponsor
- Investigators
- Frank Sciurba, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680639
- Sponsor's protocol ID
- HRC-1433-HFO-SS
- Status last verified
- Apr 2019
- First submitted
- 9 Feb 2016
- Last updated
- 6 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: There are no plans to share individual participant data (IPD), only aggregate data.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of High Frequency Oscillations With Noninvasive Ventilation (NIV) in Hypercapnic Chronic Obstructive Pulmonary Disease (COPD) Participants
- ClinicalTrials.gov ID
- NCT02680639
- Acronym / sponsor ID
- HRC-1433-HFO-SS
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- High-Frequency Ventilation, Biphasic Continuous Positive Airway Pressure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study had a high screen fail rate, enrollment was open over a year, only 3 completed.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Philips RespironicsIndustry (pharma, biotech, devices)
- Collaborators
- University of Pittsburgh Medical Center
- Study start
- 13 Nov 2015 (actual)
- Primary completion
- 24 Aug 2016 (actual)
- Study completion
- 24 Aug 2016 (actual)
- First posted
- 11 Feb 2016 (estimated)
- Results
- Posted 22 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic Obstructive Pulmonary Disease (COPD) is a major cause of chronic morbidity and mortality throughout the world, being the fourth leading cause of death in the world.
This study is designed to detect COPD participants with Expiratory Flow Limitation. EFL occurs when the airways become compressed which usually results when a pressure outside the airway exceeds the pressure inside the airway.
Participants will undergo study eligibility procedures at visit 1. At visit 2 participants will undergo a baseline auto-EPAP (Expiratory Positive Airway Pressure) measurement. Then the order will be randomized to three different treatment methods. Between each treatment there will be at least a 10 minute washout period in order for CO2 to stabilize and return to baseline.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a major cause of chronic morbidity and mortality throughout the world, being the fourth leading cause of death in the world.
COPD is a disease that results in varying degrees of dyspnea, or shortness of breath. Spirometry is a method of diagnosing COPD with the presence of a post bronchodilator FEV1 <80% of the predicted value in combination with an FEV1 / FVC <70%. This would confirm that there is a presence of airflow limitation that is not fully reversible.
The presence of airflow limitation has been identified as one of the main causes of dyspnea in patients with chronic obstructive pulmonary disease (1). Expiratory Flow Limitation (EFL) occurs when the airways become compressed which usually results when a pressure outside the airway exceeds the pressure inside the airway. As an airflow obstruction worsens, EFL appears at much lower flows for a given lung volume and it becomes present at rest or at least develops early during exercise (2).
Early detection of EFL consisted of either invasive balloon catheterization or relatively complex plethysmographic techniques. An alternative approach, and one that will be used in this study, involves utilizing the Forced Oscillation Technique (FOT).
Alternatively High Frequency Oscillations (HFO) has shown to effectively lower CO2 levels, but traditionally require intubation or a trans tracheal catheter. Treatment with a specialized noninvasive ventilator is possible and it is proposed that therapy can be augmented by the application of an optimized EPAP to splint open the lower airways in order to increase the diffusive capabilities of the high frequency oscillations into lower alveolar regions. There are approximately 25 million hypercapnic patients with EFL that could benefit from this therapy. High frequency oscillations integrated into a specialized noninvasive ventilator has the advantages of lower cost than other solutions and significantly lower medical risks. In addition, high frequency oscillation uses lower pressures to achieve effective therapy which means less chance of barotrauma and greater patient acceptance.
This study will enroll subjects at a screening visit. Screening will include a physical exam and vital signs, pregnancy test (if applicable), questionnaires, pulse oximetry, measure of carbon dioxide levels, determination of EFL by an auto- Expiratory Positive Airway Pressure (EPAP) ventilator, and spirometry.
If the patient is eligible and tolerates the above procedures, they will be asked to complete an in home-based sleep study prior to visit 2. Alice Night One/ Alice PDX are portable home sleep testing devices that record information about breathing.
At visit 2 participants will be monitored continuously via a 3 lead EKG, oxygen saturation by pulse oximetry (SPO2), Carbon Dioxide concentration(TcCO2) monitor, RespiTrace belt and ventilator data.
During Visit 2, participants will first undergo a repeat optimal EPAP determination and then trial 3 different sessions of High Frequency Oscillation (HFO) therapy for 20 minutes with at least a 10 minute wash out period between each session to allow the participant's CO2 to stabilize or return to baseline. The order of the sessions will be randomized for each patient. Participants will be placed in a semi-recumbent position and wear a nasal CPAP mask for each session. A TcCO2 monitor patch will be placed on the skin (forehead area) to collect carbon dioxide measurements during each session. A RespiTrace belt will placed on the participants' chest wall to measure chest wall and diaphragmatic excursion during each session. A 3 lead EKG will also be used to monitor cardiac activity during each session.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| optimal EPAP determination | Active comparator | Device: BiPAP Synchrony ventilatorOn the BiPAP Synchrony ventilator the EPAP (and IPAP) will be automatically adjusted by the ventilator to find optimal EPAP that abolishes EFL. Peak-to-Peak pressure oscillations will be set at 2.5 cmH2O (centimeters of water) |
| Optimized EPAP w/ no peak-to-peak | Experimental | Device: BiPAP Synchrony ventilatorOn the BiPAP Synchrony ventilator the EPAP (and IPAP) will be set at optimal pressure as determined by the Auto EPAP. Peak-to-Peak pressure oscillations will be set at 0 cmH2O (centimeters of water) |
| Optimized EPAP w/ max peak-to-peak | Experimental | Device: BiPAP Synchrony ventilatorOn the BiPAP Synchrony ventilator EPAP (and IPAP) will be set at optimal pressure as determined by the Auto EPAP. Peak-to-Peak pressure oscillations will be set at 5 cmH2O (centimeters of water) |
| non-optimized EPAP w/ no peak-to-peak | Experimental | Device: BiPAP Synchrony ventilatorOn the BiPAP Synchrony ventilator EPAP will be set at 4 cmH2O and IPAP will be set at 10 cmH2O (centimeters of water). Peak-to-Peak pressure oscillations will be set at 0 cmH2O (centimeters of water). |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 21 years of age; < 85 years of age
- Participants that have been physician diagnosed (primary diagnosis) with Obstructive Airway Disease (to include:Chronic Obstructive Pulmonary Disease (COPD); Bronchiectasis; Severe Asthma); forced expiratory volume in 1 second (FEV1) < 60% FEV1/ forced vital capacity (FVC) <60%
- Arterial CO2 > 45 mmHg as determined by blood gas (PaCO2) or transcutaneous (tcCO2) >50 within the past month
- Ability to provide consent
- Participant has not used Non-Invasive Ventilation (BiPAP/CPAP) therapy in the past 8 hours
Key exclusion criteria (12 listed)
- Participants that have not returned to their baseline health status from an exacerbation of COPD or other pulmonary problems or have not established at least two weeks of stability at a new baseline.
- Use of antibiotics or prednisone for a COPD exacerbation within the previous 4 weeks.
- Uncontrolled Hypertension
- Participants that require greater than 3 liters of oxygen at rest
- History of cardiovascular instability, including uncontrolled ventricular arrhythmias, angina, diastolic BP > 100 mmHg and all Participants with pacemakers
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 |
|---|---|---|
| BiPAP Synchrony ventilatorThe BiPAP Synchrony ventilator will be used to determine Expiratory Positive Airway Pressure (EPAP). The ventilator will be used with varying pressure supports and oscillations depending on what arm of the study the participant is in. | Device | Optimized EPAP w/ max peak-to-peak, Optimized EPAP w/ no peak-to-peak, non-optimized EPAP w/ no peak-to-peak, optimal EPAP determination |
Primary outcome
Carbon Dioxide Levels
Time frame: Baseline and 20 minutes
Transcutaneous carbon dioxide (TcCO2) monitoring is a non-invasive alternative to arterial blood sampling. Carbon Dioxide Levels will be measured for each participant as they complete each arm.
3 secondary outcomes
Respiratory Rate
Time frame: 20 minutes
Tidal Volume
Time frame: 20 minutes
Minute Ventilation for Carbon Dioxide
Time frame: 20 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data (IPD), only aggregate data.
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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.
Frank Sciurba, MD principal investigator
University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BiPAP Synchrony ventilator in people with Chronic Obstructive Pulmonary Disease, 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 6 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 6 May 2019. 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 22 Apr 2019). 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?
Carbon Dioxide Levels (time frame: Baseline and 20 minutes). 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 6 May 2019.