Back to resultsHigh Intensity Non-Invasive Positive Pressure Ventilation (HINPPV) (HINPPV)
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bilevel positive airway pressure (BiPAP)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD)
Eligibility Criteria
Inclusion Criteria
- Patient diagnosed with chronic obstructive pulmonary disease (COPD)
- Age < or = to 80 years
- Forced expiratory volume in one second (FEV1) < 50% of predicted value
- FEV1/Forced vital capacity (FVC) < 70% of predicted value
- Total lung capacity (TLC) > 90% predicted by plethysmography
- Body Mass Index (BMI) < 35
- Patient has provided written informed consent using a form that has been approved by the Internal Review Board (IRB)
Daytime PaCO2 ≥ 52 mm Hg, at rest on room air (Denver > 48 mm Hg) with one of the following symptoms of hypercapnia:
- Fatigue
- Sleepiness
- Headaches
- Post hospital discharge at least one month prior to screening visit
- Participant is willing and able to complete all required assessments and procedures
- Participant has no child bearing potential OR a negative pregnancy test in a woman of childbearing potential
Exclusion Criteria
- FEV1 < 15% of predicted value
- Diagnosis of obstructive sleep apnea (OSA) [Apnea hypopnea index (AHI) > 15 per hour]
- Current Non-invasive Positive Pressure Ventilation (NIPPV), Positive Airway Pressure (PAP) or Non-invasive Ventilation (NIV) users
Signs / symptoms of acute exacerbation within the previous month: two of the following criteria:
- Increasing cough
- Purulent sputum
- Current use of antibiotics
- pH < 7.35
- Any major non COPD disease or condition that interferes with completion of initial or follow-up assessments, such as uncontrolled 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 as deemed appropriate by investigator as determined by review of medical history and / or patient reported medical history
- History of pneumothorax
- Anatomical facial abnormalities precluding placement of a nasal or facial mask
- Diffuse parenchymal lung disease other than emphysema
- Inability to maintain Oxygen (O2) saturation >90% on 5L/min ( five liters) nasal O2 at rest
- Sustained need for >10 mg prednisone daily or equivalent dose of other systemic corticosteroid
- Pregnancy
- Excessive alcohol intake (≥ 6oz hard liquor daily), or illicit drug use
- Daily use of narcotics (greater than 30 mg morphine equivalent)
- Patient is currently enrolled in another interventional clinical trial
Sites / Locations
- Temple University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
High Intensity Non Invasive Pos.Pressure
Arm Description
The High Intensity Non-invasive Pos.Pressure trial is a single arm interventional study. Hypercapnic COPD participants that meet eligibility criteria will receive high intensity non-invasive positive pressure ventilation (HINPPV) for 90 days. Participants will receive HINPPV via bilevel positive airway pressure (BiPAP Synchrony) if they require an inspiratory positive airway pressure (IPAP) less than or equal to 30 cmH2O (centimeters of water); or the Trilogy ventilator if they require an IPAP greater than 30 cmH2O.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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.
Exercise Capacity
Exercise capacity will be measured by comparing the 6 minute walk test as measured in meters from baseline to 3 months
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.
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.
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01214200
Brief Title
High Intensity Non-Invasive Positive Pressure Ventilation (HINPPV)
Acronym
HINPPV
Official Title
High Intensity Non-Invasive Positive Pressure Ventilation (HINPPV) for Stable Hypercapnic Chronic Obstructive Pulmonary Disease (COPD) Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Respironics
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Intensity Non Invasive Pos.Pressure
Arm Type
Experimental
Arm Description
The High Intensity Non-invasive Pos.Pressure trial is a single arm interventional study. Hypercapnic COPD participants that meet eligibility criteria will receive high intensity non-invasive positive pressure ventilation (HINPPV) for 90 days. Participants will receive HINPPV via bilevel positive airway pressure (BiPAP Synchrony) if they require an inspiratory positive airway pressure (IPAP) less than or equal to 30 cmH2O (centimeters of water); or the Trilogy ventilator if they require an IPAP greater than 30 cmH2O.
Intervention Type
Device
Intervention Name(s)
Bilevel positive airway pressure (BiPAP)
Other Intervention Name(s)
Synchrony BiPAP ventilator and Trilogy Ventilator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2)
Description
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
Secondary Outcome Measure Information:
Title
Health Status
Description
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
Title
Maximal Inspiratory Pressure
Description
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
Title
Exercise Capacity
Description
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
Title
Dyspnea at Rest and With Exertion
Description
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
Title
Sleepiness
Description
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
Title
Duration of Sleep
Description
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
Title
Efficiency of Sleep
Description
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
10. Eligibility
Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Patient diagnosed with chronic obstructive pulmonary disease (COPD)
Age < or = to 80 years
Forced expiratory volume in one second (FEV1) < 50% of predicted value
FEV1/Forced vital capacity (FVC) < 70% of predicted value
Total lung capacity (TLC) > 90% predicted by plethysmography
Body Mass Index (BMI) < 35
Patient has provided written informed consent using a form that has been approved by the Internal Review Board (IRB)
Daytime PaCO2 ≥ 52 mm Hg, at rest on room air (Denver > 48 mm Hg) with one of the following symptoms of hypercapnia:
Fatigue
Sleepiness
Headaches
Post hospital discharge at least one month prior to screening visit
Participant is willing and able to complete all required assessments and procedures
Participant has no child bearing potential OR a negative pregnancy test in a woman of childbearing potential
Exclusion Criteria
FEV1 < 15% of predicted value
Diagnosis of obstructive sleep apnea (OSA) [Apnea hypopnea index (AHI) > 15 per hour]
Current Non-invasive Positive Pressure Ventilation (NIPPV), Positive Airway Pressure (PAP) or Non-invasive Ventilation (NIV) users
Signs / symptoms of acute exacerbation within the previous month: two of the following criteria:
Increasing cough
Purulent sputum
Current use of antibiotics
pH < 7.35
Any major non COPD disease or condition that interferes with completion of initial or follow-up assessments, such as uncontrolled 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 as deemed appropriate by investigator as determined by review of medical history and / or patient reported medical history
History of pneumothorax
Anatomical facial abnormalities precluding placement of a nasal or facial mask
Diffuse parenchymal lung disease other than emphysema
Inability to maintain Oxygen (O2) saturation >90% on 5L/min ( five liters) nasal O2 at rest
Sustained need for >10 mg prednisone daily or equivalent dose of other systemic corticosteroid
Pregnancy
Excessive alcohol intake (≥ 6oz hard liquor daily), or illicit drug use
Daily use of narcotics (greater than 30 mg morphine equivalent)
Patient is currently enrolled in another interventional clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald Criner, MD
Organizational Affiliation
Temple Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
12. IPD Sharing Statement
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High Intensity Non-Invasive Positive Pressure Ventilation (HINPPV)
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