High Intensity Non-Invasive Positive Pressure Ventilation (HINPPV)

NCT ID: NCT01214200

Last Updated: 2019-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-12-31

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High Intensity Non Invasive Pos.Pressure

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.

Group Type: EXPERIMENTAL

Bilevel positive airway pressure (BiPAP)

Intervention Type: DEVICE

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.

Interventions

Bilevel positive airway pressure (BiPAP)

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.

Intervention Type: DEVICE

Other Intervention Names

Synchrony BiPAP ventilator and Trilogy Ventilator

Eligibility 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 ( five liters) 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

• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philips Respironics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerald Criner, MD

Role: PRINCIPAL_INVESTIGATOR

Temple Medical Center

Locations

Temple University Hospital

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

HRC-0927-HINPPV-MS

Identifier Type: -

Identifier Source: org_study_id