The Use of High Frequency Oscillations With NIV in Hypercapnic COPD Participants

Stopped early · Not applicable

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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.

Key facts

Study ID

NCT02680639

Run by

Philips Respironics

People needed

10

Starts

2015-11-13

Expected to finish

2016-08-24

Last updated by the study team

2019-05-06

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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