The Use of High Frequency Oscillations With NIV in Hypercapnic COPD Participants
Chronic Obstructive Pulmonary Disease
About this trial
This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease focused on measuring High-Frequency Ventilation, Biphasic Continuous Positive Airway Pressure
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- University of Pittsburgh Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Experimental
Experimental
Experimental
optimal EPAP determination
Optimized EPAP w/ no peak-to-peak
Optimized EPAP w/ max peak-to-peak
non-optimized EPAP w/ no peak-to-peak
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)
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)
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)
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).