The aim of this study is to assess the effectiveness of an Airway Clearance System.
The study will compare the effectiveness of The Monarch™ System and The Vest® Airway Clearance System. All subjects will receive treatment with both systems and endpoints will be compared.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
High frequency chest wall oscillation (HFCWO) therapy is commonly prescribed to provide routine airway clearance in patients with a need for regular airway clearance therapy. HFCWO generates high velocity expiratory airflow that is thought to mobilize secretions by the sheer force created.
Generates airflow at frequencies similar to those provided by HFCWO and also provides direct percussive therapy.
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
Wet Weight of Sputum Produced
Assessment of the wet weight of total sputum that is produced as a result of each of two therapy sessions. The total wet weight includes the wet weight of sputum collected each 30-minute therapy session + the wet weight of sputum collected during a 1-hour collection period following each therapy.
Time frame: Through study completion, an average of 2 months
Sputum Volume
Assessment of the total volume of sputum that is produced as a result of each of two therapy sessions. The total volume includes the volume of sputum collected each 30-minute therapy session + the volume of sputum collected during a 1-hour collection period following each therapy.
Time frame: Through study completion, an average of 2 months
Functional Respiratory Imaging
Functional Respiratory Imaging will be completed utilizing CT scans. The CT scans are to be completed before airway clearance therapy on each day and after the one-hour sputum collection following the airway clearance therapy (a minimum of one hour following completion of the airway clearance therapy).
Time frame: Through study completion, an average of 2 months
Brody Scores (Scoring of CT Scans)
Brody Scores will be completed utilizing CT scans. The CT scans are to be completed before airway clearance therapy on each day and after the one-hour sputum collection following the airway clearance therapy (a minimum of one hour following completion of the airway clearance therapy).
Time frame: Through study completion, an average of 2 months
Lung Clearance Index
Measurement of how much ventilation is required to completely clear the full residual capacity using the Inert Gas Multi-Breath Washout method completed pre- and post-therapy -- before the airway clearance therapy on each day and after the one-hour sputum collection following the airway clearance therapy (a minimum of one hour following completion of the airway clearance therapy).
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Time frame: Through study completion, an average of 2 months
Subjective satisfaction surveys
Patient satisfaction with therapy will be assessed post therapy. (survey will be completed a minimum of one hour following completion of the airway clearance therapy).
Time frame: Through study completion, an average of 2 months
Spirometry
Forced expiratory spirometry maneuvers will be completed before and after therapy. -- before the airway clearance therapy on each day and after the one-hour sputum collection following the airway clearance therapy (a minimum of one hour following completion of the airway clearance therapy).
Time frame: Through study completion, an average of 2 months