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Evaluation of Device Settings for Airway Clearance Using The Monarch Airway Clearance System (HFCWO)

Primary Purpose

Cystic Fibrosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Monarch Airway Clearance System
Sponsored by
Hill-Rom
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Cystic Fibrosis

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Documented diagnosis of CF (by sweat test and/or genetics
  • Age > 15 years
  • Require regular home airway clearance therapy
  • Current user of The Monarch® System with a minimum of 4 weeks experience with the device
  • Signed informed consent. If patient is a minor, parents/guardians must give written informed consent and patient must give written assent
  • Patient must be on a stable regimen of CF medication

Exclusion Criteria:

  • History of pneumothorax within the past 6 months prior to study visit
  • History of hemoptysis requiring embolization within the past 12 months prior to study visit or hemoptysis of > 100 ml within a 24-hour period within the past 30 days
  • History of lobectomy
  • Recent chest surgery or chest trauma
  • Inability to perform The Monarch® System therapy as directed
  • Pregnant or lactating female
  • Have a pacemaker or implantable cardioverter defibrillator (ICD)
  • Requirement for oral or IV antibiotics that are not part of the subject's usual course of treatment within the past 14 days prior to screening

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Monarch device settings assessment group

    Arm Description

    Patients with cystic fibrosis who have experience with the Monarch Airway Clearance System will be enrolled in the study. The duration of subject participation is approximately 4 - 6 hours during 1 study visit. Each subject will receive therapy with The Monarch® System at multiple frequency and intensity combinations as defined in the Study procedures.

    Outcomes

    Primary Outcome Measures

    Peak oscillating expiratory airflow measurements
    Subjects will be treated with the Monarch® system using multiple frequency/intensity combination settings. After adjusting the therapy to the desired setting, subjects will be instructed breath through the mouthpiece for the flow measurement system, to breathe normally and continue relaxed breathing. Oscillating flow and volume measurement will be captured by the system over a period of 30 to 60 seconds of relaxed breathing. Data from the measurement of oscillating flow for each frequency/intensity combination setting will be processed following the completion of the testing

    Secondary Outcome Measures

    Oscillating volume
    Oscillating volume measurement will be conducted concurrently with the measurement of flow. Subjects will be treated with the Monarch® system using multiple frequency/intensity combination settings as described above. Data from the measurement of oscillating volume for each frequency/intensity combination setting will be processed following the completion of the testing
    Patient comfort/discomfort evaluated by 100 mm visual analogue scale (VAS)
    Following the completion of testing for each frequency/intensity combination setting, subjects will rate the level of comfort/discomfort of the setting on a VAS. A Visual Analogue Scale is a psychometric response scale which will be used as a measuring instrument for subjective comfort or discomfort. It is a measurement instrument that ranges across a continuum of values and used to measure the intensity or frequency of various symptoms. The Visual Analogue Scale ranges from (0 to 100 mm). Zero means very uncomfortable/intolerable and 100 means very comfortable. The subject will mark the line for each setting combination to indicate the level of comfort or discomfort. After the Study visit, the research staff will measure the mark on the line and document the value.

    Full Information

    First Posted
    August 22, 2018
    Last Updated
    December 27, 2018
    Sponsor
    Hill-Rom
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03645473
    Brief Title
    Evaluation of Device Settings for Airway Clearance Using The Monarch Airway Clearance System
    Acronym
    HFCWO
    Official Title
    Evaluation of Device Settings for Airway Clearance Using The Monarch Airway Clearance System
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 24, 2019 (Anticipated)
    Primary Completion Date
    March 12, 2019 (Anticipated)
    Study Completion Date
    April 12, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hill-Rom

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study will be an open label laboratory study with all subjects receiving HFCWO with The Monarch® System Objective: Assess device settings and to identify frequency/pressure (intensity) combinations that produce high airflow and oscillating volume Methodology: Subjects will receive HFCWO using The Monarch® System at multiple frequency / intensity combinations on a single visit day. Frequency / intensity combinations will be evaluated to determine which settings produce highest airflow and highest oscillating volume.
    Detailed Description
    The study will be an open-label, laboratory study. All enrolled subjects will receive HFCWO therapy with the Monarch® system. The study will be conducted at one (1) site in the US. The study will evaluate oscillating airflow and oscillating volume induced during therapy with the Monarch® system. Subjects will also rate the comfort of the therapy. Patients with cystic fibrosis (CF) who meet all of the inclusion criteria and none of the exclusion criteria will be enrolled in the study. Therapy with the Monarch® system will be delivered using multiple frequency/intensity combination settings. The order of settings will be randomized for each study subject. During therapy oscillating flow and volume measurements will be obtained for each frequency/intensity combination. Following each frequency/intensity combination, subjects will respond to a subjective assessment of the comfort of the therapy by rating the comfort on a visual analogue scale (VAS).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cystic Fibrosis

    7. Study Design

    Primary Purpose
    Device Feasibility
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Monarch device settings assessment group
    Arm Type
    Experimental
    Arm Description
    Patients with cystic fibrosis who have experience with the Monarch Airway Clearance System will be enrolled in the study. The duration of subject participation is approximately 4 - 6 hours during 1 study visit. Each subject will receive therapy with The Monarch® System at multiple frequency and intensity combinations as defined in the Study procedures.
    Intervention Type
    Device
    Intervention Name(s)
    Monarch Airway Clearance System
    Intervention Description
    HFCWO Airway Clearance Device
    Primary Outcome Measure Information:
    Title
    Peak oscillating expiratory airflow measurements
    Description
    Subjects will be treated with the Monarch® system using multiple frequency/intensity combination settings. After adjusting the therapy to the desired setting, subjects will be instructed breath through the mouthpiece for the flow measurement system, to breathe normally and continue relaxed breathing. Oscillating flow and volume measurement will be captured by the system over a period of 30 to 60 seconds of relaxed breathing. Data from the measurement of oscillating flow for each frequency/intensity combination setting will be processed following the completion of the testing
    Time Frame
    4-6 hours
    Secondary Outcome Measure Information:
    Title
    Oscillating volume
    Description
    Oscillating volume measurement will be conducted concurrently with the measurement of flow. Subjects will be treated with the Monarch® system using multiple frequency/intensity combination settings as described above. Data from the measurement of oscillating volume for each frequency/intensity combination setting will be processed following the completion of the testing
    Time Frame
    4-6 hours
    Title
    Patient comfort/discomfort evaluated by 100 mm visual analogue scale (VAS)
    Description
    Following the completion of testing for each frequency/intensity combination setting, subjects will rate the level of comfort/discomfort of the setting on a VAS. A Visual Analogue Scale is a psychometric response scale which will be used as a measuring instrument for subjective comfort or discomfort. It is a measurement instrument that ranges across a continuum of values and used to measure the intensity or frequency of various symptoms. The Visual Analogue Scale ranges from (0 to 100 mm). Zero means very uncomfortable/intolerable and 100 means very comfortable. The subject will mark the line for each setting combination to indicate the level of comfort or discomfort. After the Study visit, the research staff will measure the mark on the line and document the value.
    Time Frame
    4-6 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Documented diagnosis of CF (by sweat test and/or genetics Age > 15 years Require regular home airway clearance therapy Current user of The Monarch® System with a minimum of 4 weeks experience with the device Signed informed consent. If patient is a minor, parents/guardians must give written informed consent and patient must give written assent Patient must be on a stable regimen of CF medication Exclusion Criteria: History of pneumothorax within the past 6 months prior to study visit History of hemoptysis requiring embolization within the past 12 months prior to study visit or hemoptysis of > 100 ml within a 24-hour period within the past 30 days History of lobectomy Recent chest surgery or chest trauma Inability to perform The Monarch® System therapy as directed Pregnant or lactating female Have a pacemaker or implantable cardioverter defibrillator (ICD) Requirement for oral or IV antibiotics that are not part of the subject's usual course of treatment within the past 14 days prior to screening

    12. IPD Sharing Statement

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    Evaluation of Device Settings for Airway Clearance Using The Monarch Airway Clearance System

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