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

NCT03645473 | Unknown

• 1 other identifier: CR-RR-2018-002
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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

  4-6 hours

Secondary Outcomes (2)

• Oscillating volume

  4-6 hours

• Patient comfort/discomfort evaluated by 100 mm visual analogue scale (VAS)

  4-6 hours

Study Arms (1)

Monarch device settings assessment group

EXPERIMENTAL

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.

Device: Monarch Airway Clearance System

Interventions

Monarch Airway Clearance System DEVICE

HFCWO Airway Clearance Device

Monarch device settings assessment group

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hill-Rom: lead

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

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

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 24, 2018
• Study Start: January 24, 2019
• Primary Completion: March 12, 2019
• Study Completion: April 12, 2019
• Last Updated: December 31, 2018

Record last verified: 2018-12