Clinical trial NCT03645473: Evaluation of Device Settings for Airway Clearance Using The Monarch Airway Clearance System
Official title: Evaluation of Device Settings for Airway Clearance Using The Monarch Airway Clearance System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: Hill-Rom
Sponsor class: INDUSTRY
First posted: 2018-08-24
Enrollment: 10
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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).

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

Primary outcomes:
measure: Peak oscillating expiratory airflow measurements
timeFrame: 4-6 hours
Secondary outcomes:
measure: Oscillating volume
timeFrame: 4-6 hours
measure: Patient comfort/discomfort evaluated by 100 mm visual analogue scale (VAS)
timeFrame: 4-6 hours
Other outcomes:
Locations:
Study officials:
References: