High Intensity Non-Invasive Positive Pressure Ventilation (HINPPV)

NCT01214200 | Completed Results

• 1 other identifier: HRC-0927-HINPPV-MS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• 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.

  Before and after 3 months of therapy

Secondary Outcomes (7)

• Health Status

  Before and after 3 months of therapy

• Maximal Inspiratory Pressure

  Before and after 3 months of therapy

• Exercise Capacity

  Before and after 3 months of therapy

• Dyspnea at Rest and With Exertion

  Before and after 3 months of therapy

• Sleepiness

  Before and after 3 months of therapy

Study Arms (1)

High Intensity Non Invasive Pos.Pressure

EXPERIMENTAL

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.

Device: Bilevel positive airway pressure (BiPAP)

Interventions

Bilevel positive airway pressure (BiPAP) 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.

Also known as: Synchrony BiPAP ventilator and Trilogy Ventilator

High Intensity Non Invasive Pos.Pressure

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philips Respironics: lead

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Mark Weir, MBChB
• Organization: Temple University School of Medicine

mark.weir@tuhs.temple.edu

215-707-5864

Study Officials

• Gerald Criner, MD

  Temple Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2010
• First Posted: October 4, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 2, 2019
• Results First Posted: January 2, 2019

Record last verified: 2018-12

Locations

US (1)