The Use of High Frequency Oscillations With Noninvasive Ventilation (NIV) in Hypercapnic Chronic Obstructive Pulmonary Disease (COPD) Participants
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Carbon Dioxide Levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
optimal EPAP determination
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)
干预措施: BiPAP Synchrony ventilator (Device)
Optimized EPAP w/ no peak-to-peak
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)
干预措施: BiPAP Synchrony ventilator (Device)
Optimized EPAP w/ max peak-to-peak
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)
干预措施: BiPAP Synchrony ventilator (Device)
non-optimized EPAP w/ no peak-to-peak
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).
干预措施: BiPAP Synchrony ventilator (Device)
结局指标
主要结局
Carbon Dioxide Levels
时间窗: 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.
次要结局
- Respiratory Rate(20 minutes)
- Tidal Volume(20 minutes)
- Minute Ventilation for Carbon Dioxide(20 minutes)