Trials / Unknown
UnknownNCT03645473
Evaluation of Device Settings for Airway Clearance Using The Monarch Airway Clearance System
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- Hill-Rom · Industry
- Sex
- All
- Age
- 15 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Monarch Airway Clearance System | HFCWO Airway Clearance Device |
Timeline
- Start date
- 2019-01-24
- Primary completion
- 2019-03-12
- Completion
- 2019-04-12
- First posted
- 2018-08-24
- Last updated
- 2018-12-31
Source: ClinicalTrials.gov record NCT03645473. Inclusion in this directory is not an endorsement.