The Use of High Frequency Oscillations With NIV in Hypercapnic COPD Participants

NCT02680639 | Terminated Results

• 1 other identifier: HRC-1433-HFO-SS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is a major cause of chronic morbidity and mortality throughout the world, being the fourth leading cause of death in the world. This study is designed to detect COPD participants with Expiratory Flow Limitation. EFL occurs when the airways become compressed which usually results when a pressure outside the airway exceeds the pressure inside the airway. Participants will undergo study eligibility procedures at visit 1. At visit 2 participants will undergo a baseline auto-EPAP (Expiratory Positive Airway Pressure) measurement. Then the order will be randomized to three different treatment methods. Between each treatment there will be at least a 10 minute washout period in order for CO2 to stabilize and return to baseline.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

High-Frequency Ventilation; Biphasic Continuous Positive Airway Pressure

Outcome Measures

Primary Outcomes (1)

• Carbon Dioxide Levels

  Transcutaneous carbon dioxide (TcCO2) monitoring is a non-invasive alternative to arterial blood sampling. Carbon Dioxide Levels will be measured for each participant as they complete each arm.

  Baseline and 20 minutes

Secondary Outcomes (3)

• Respiratory Rate

  20 minutes

• Tidal Volume

  20 minutes

• Minute Ventilation for Carbon Dioxide

  20 minutes

Study Arms (4)

optimal EPAP determination

ACTIVE COMPARATOR

On the BiPAP Synchrony ventilator the EPAP (and IPAP) will be automatically adjusted by the ventilator to find optimal EPAP that abolishes EFL. Peak-to-Peak pressure oscillations will be set at 2.5 cmH2O (centimeters of water)

Device: BiPAP Synchrony ventilator

Optimized EPAP w/ no peak-to-peak

EXPERIMENTAL

On the BiPAP Synchrony ventilator the EPAP (and IPAP) will be set at optimal pressure as determined by the Auto EPAP. Peak-to-Peak pressure oscillations will be set at 0 cmH2O (centimeters of water)

Device: BiPAP Synchrony ventilator

Optimized EPAP w/ max peak-to-peak

EXPERIMENTAL

On the BiPAP Synchrony ventilator EPAP (and IPAP) will be set at optimal pressure as determined by the Auto EPAP. Peak-to-Peak pressure oscillations will be set at 5 cmH2O (centimeters of water)

Device: BiPAP Synchrony ventilator

non-optimized EPAP w/ no peak-to-peak

EXPERIMENTAL

On the BiPAP Synchrony ventilator EPAP will be set at 4 cmH2O and IPAP will be set at 10 cmH2O (centimeters of water). Peak-to-Peak pressure oscillations will be set at 0 cmH2O (centimeters of water).

Device: BiPAP Synchrony ventilator

Interventions

BiPAP Synchrony ventilator DEVICE

The BiPAP Synchrony ventilator will be used to determine Expiratory Positive Airway Pressure (EPAP). The ventilator will be used with varying pressure supports and oscillations depending on what arm of the study the participant is in.

Optimized EPAP w/ max peak-to-peak; Optimized EPAP w/ no peak-to-peak; non-optimized EPAP w/ no peak-to-peak; optimal EPAP determination

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 21 years of age; \< 85 years of age
• Participants that have been physician diagnosed (primary diagnosis) with Obstructive Airway Disease (to include:Chronic Obstructive Pulmonary Disease (COPD); Bronchiectasis; Severe Asthma); forced expiratory volume in 1 second (FEV1) \< 60% FEV1/ forced vital capacity (FVC) \<60%
• Arterial CO2 \> 45 mmHg as determined by blood gas (PaCO2) or transcutaneous (tcCO2) \>50 within the past month
• Ability to provide consent
• Participant has not used Non-Invasive Ventilation (BiPAP/CPAP) therapy in the past 8 hours
• Participant has no child bearing potential OR a negative pregnancy test in a woman of childbearing potential

You may not qualify if:

• Participants that have not returned to their baseline health status from an exacerbation of COPD or other pulmonary problems or have not established at least two weeks of stability at a new baseline.
• Use of antibiotics or prednisone for a COPD exacerbation within the previous 4 weeks.
• Uncontrolled Hypertension
• Participants that require greater than 3 liters of oxygen at rest
• History of cardiovascular instability, including uncontrolled ventricular arrhythmias, angina, diastolic BP \> 100 mmHg and all Participants with pacemakers
• Any major non-COPD uncontrolled disease or condition, such as congestive heart failure, 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 condition as deemed appropriate by investigator as determined by review of medical history and / or participant reported medical history
• History of pneumothorax
• Apnea Hypopnea Index (AHI) \> 15 via in-home sleep study
• Excessive alcohol intake (\> 6oz hard liquor, 48 oz. beer or 20 oz. wine daily), or illicit drug use by review of medical history and / or participant reported medical history
• Daily use of prescribed narcotics (greater than 30 mg morphine equivalent)
• History of Giant bullous emphysema
• A positive urine pregnancy test when screening for study

Sponsors & Collaborators

• Philips Respironics: lead
• University of Pittsburgh Medical Center: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Study terminated due to low enrollment. Washout period between sessions of 20-30 minutes was not sufficient for CO2 to return to baseline.

Results Point of Contact

• Title: Senior Clinical Development Scientist
• Organization: Philips

chuck.cain@philips.com

(724) 733-5835

Study Officials

• Frank Sciurba, MD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: February 11, 2016
• Study Start: November 13, 2015
• Primary Completion: August 24, 2016
• Study Completion: August 24, 2016
• Last Updated: May 6, 2019
• Results First Posted: April 22, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)