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High Intensity Non-Invasive Positive Pressure Ventilation (HINPPV)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gary Lotz, Philips Respironics
ClinicalTrials.gov Identifier:
NCT01214200
First received: June 29, 2010
Last updated: October 23, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease (COPD)
 Device: High Intensity Non Invasive Pos. Pressure
Device: Bilevel positive airway pressure (BiPAP)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High Intensity Non-Invasive Positive Pressure Ventilation (HINPPV) for Stable Hypercapnic Chronic Obstructive Pulmonary Disease (COPD) Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Philips Respironics:

Primary Outcome Measures:
  • Daytime partial pressure of carbon dioxide in arterial blood (PaCO2) [ Time Frame: Before and after 3 months of therapy ] [ Designated as safety issue: No ]
    Daytime PaCO2 levels assessed after using high intensity non-invasive positive pressure ventilation (HINPPV) are better than the participants' baseline daytime PaCO2 levels.


Secondary Outcome Measures:
  • Health Status [ Time Frame: Before and after 3 months of therapy ] [ Designated as safety issue: No ]
    Health status will improve as evidenced by favorable subjective response to improved gas exchange and sleep quality questions.

  • Duration, Efficiency and Quality of Sleep and Sleepiness [ Time Frame: Before and after 3 months of therapy ] [ Designated as safety issue: No ]
    HINPPV will enhance the quantity and quality of sleep and reduce sleepiness.

  • Maximal Inspiratory Pressure [ Time Frame: Before and after 3 months of therapy ] [ Designated as safety issue: No ]
    HINPPV will improve inspiratory muscle strength.

  • Exercise Capacity [ Time Frame: Before and after 3 months of therapy ] [ Designated as safety issue: No ]
    HINPPV will increase exercise tolerance.

  • Dyspnea at rest and with exertion [ Time Frame: Before and after 3 months of therapy ] [ Designated as safety issue: No ]
    HINPPV will reduce exercise-related dyspnea.


Estimated Enrollment: 20
Study Start Date: August 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Intensity Non-invasive Pos.Pressure
The High Intensity Non-invasive Pos.Pressure trial is a single arm interventional study. All 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) 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.
 Device: High Intensity Non Invasive Pos. Pressure
High Intensity Non Invasive Positive Pressure Ventilation (HINPPV) will be applied to hypercapnic chronic obstructive pulmonary disease (COPD) patients for a period of 3 months. The Respironics bilevel positive airway pressure (BiPAP) Synchrony device has a maximum inspiratory positive airway pressure (IPAP) setting of 30 cmH2O and will be used for all participants in the study. If it is determined through the titration study the participant requires an IPAP greater than 30 cmH2O, they will be placed on the Respironics Trilogy ventilator.
Device: Bilevel positive airway pressure (BiPAP)
This is a single arm interventional study. All 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) 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.

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 ( ABGs, PFTs, 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.

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Patient diagnosed with chronic obstructive pulmonary disease (COPD)
  2. Age < or = to 80 years
  3. Forced expiratory volume in one second (FEV1) < 50% of predicted value
  4. FEV1/Forced vital capacity (FVC) < 70% of predicted value
  5. Total lung capacity (TLC) > 90% predicted by plethysmography
  6. Body Mass Index (BMI) < 35
  7. Patient has provided written informed consent using a form that has been approved by the Internal Review Board (IRB)

  8. 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
  9. Post hospital discharge at least one month prior to screening visit
  10. Participant is willing and able to complete all required assessments and procedures
  11. Participant has no child bearing potential OR a negative pregnancy test in a woman of childbearing potential

Exclusion Criteria

  1. FEV1 < 15% of predicted value
  2. Diagnosis of obstructive sleep apnea (OSA) [Apnea hypopnea index (AHI) > 15 per hour]
  3. Current Non-invasive Positive Pressure Ventilation (NIPPV), Positive Airway Pressure (PAP) or Non-invasive Ventilation (NIV) users

  4. 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
  5. 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
  6. History of pneumothorax
  7. Anatomical facial abnormalities precluding placement of a nasal or facial mask
  8. Diffuse parenchymal lung disease other than emphysema
  9. Inability to maintain Oxygen (O2) saturation >90% on 5L/min nasal O2 at rest
  10. Sustained need for >10 mg prednisone daily or equivalent dose of other systemic corticosteroid
  11. Pregnancy
  12. Excessive alcohol intake (≥ 6oz hard liquor daily), or illicit drug use
  13. Daily use of narcotics (greater than 30 mg morphine equivalent)
  14. Patient is currently enrolled in another interventional clinical trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01214200

Locations
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Philips Respironics
Investigators
Principal Investigator: Gerald Criner, MD Temple Medical Center
  More Information

No publications provided

Responsible Party: Gary Lotz, Director of clinical research, Philips Respironics
ClinicalTrials.gov Identifier: NCT01214200     History of Changes
Other Study ID Numbers: HRC-0927-HINPPV-MS
Study First Received: June 29, 2010
Last Updated: October 23, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 17, 2013