The purpose of this pilot study is to evaluate the effect of high intensity non-invasive positive pressure ventilation (HINPPV) for stable, hypercapnic COPD patients. The investigators believe that HINPPV, used at least 6 hours nocturnally over three months, will benefit the stable hypercapnic COPD patient through a reduction in the daytime partial pressure of carbon dioxide in arterial blood (PaCO2) levels.
The High Intensity Non-invasive Positive Pressure trial is a single arm interventional study. The purpose of this study is to evaluate the effect of High Intensity Non-invasive ventilation (HINPPV) in stable Chronic Obstructive Pulmonary patients with chronically elevated carbon dioxide levels. Participants will undergo various testing ( arterial blood gas (ABG), Pulmonary Function Test (PFTs), Polysomnography (PSGs), 6 minute walk tests)over a 3 month period to determine if this type of therapy will improve daytime carbon dioxide levels. The participants will also complete quality of life questionnaires to help ascertain improvements in their daily living activities.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
This is a single arm interventional study. Hypercapnic COPD participants that meet eligibility criteria will receive high intensity non-invasive positive pressure ventilation(HINPPV). Participants will receive HINPPV via bilevel positive airway pressure (BiPAP) via a Synchrony ventilator if they require an inspiratory positive airway pressure (IPAP) less than or equal to 30 cmH2O; or the Trilogy ventilator if they require an IPAP greater than 30 cmH2O.
Temple University Hospital
Philadelphia, Pennsylvania, United States
Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2)
Daytime PaCO2 levels assessed after using high intensity non-invasive positive pressure ventilation (HINPPV) are compared to the participants' baseline daytime PaCO2 levels.
Time frame: Before and after 3 months of therapy
Health Status
Health status was assessed by completing different surveys at baseline and after 3 months of therapy. The Calgary Sleep Apnea Quality of Life was administered at baseline and 3 months. It is a 35-item, interview-administered scale, the SAQLI evaluates four domains of quality of life associated with sleep apnea: daily functioning, social interactions, emotional functioning, and symptoms. The SAQLI use a 7-point Likert scale ranging from 1 (maximal impairment) to 7 (no impairment).
Time frame: Before and after 3 months of therapy
Maximal Inspiratory Pressure
The Maximal inspiratory pressure (MIP) is the maximum negative pressure that can be generated from one inspiratory effort starting from functional residual capacity (FRC) or residual volume (RV). This was assessed at baseline and after 3 months of therapy.
Time frame: Before and after 3 months of therapy
Exercise Capacity
Exercise capacity will be measured by comparing the 6 minute walk test as measured in meters from baseline to 3 months
Time frame: Before and after 3 months of therapy
Dyspnea at Rest and With Exertion
The modifed Borg scale was used to measure dyspnea. The Dyspnea Borg scale measures patients perceived level of dyspnea. The scale ranges from 0 to 10, 0- nothing at all and 10 is maximal.
Time frame: Before and after 3 months of therapy
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Sleepiness
Sleepiness will be evaluated by measuring the the baseline and 3 month Epworth Sleepiness Scale. The Epworth Sleepiness Scale is an 8 question survey regarding daytime sleepiness. The higher the score the higher the chance of dozing during the day. Each question is rated on a 0 to 3 scale of chance of dozing or sleeping. 0 would be no chance, 3 would be the highest chance.
Time frame: Before and after 3 months of therapy
Duration of Sleep
Duration of sleep will be measured using total sleep time. Total sleep time is the overall number of minutes of sleep, this will be compared from baseline to 3 months.
Time frame: Before and after 3 months of therapy
Efficiency of Sleep
Sleep efficiency will be measured by taking the total sleep time by the total time in bed. This is measured as a percentage and compared from baseline to 3 months
Time frame: Before and after 3 months of therapy