A Pilot Study to Assess the Effects of Simeox 200 Airway Clearance Device in Bronchiectasis Patients With Chronic Mucus Hypersecretion
Inogen Inc.
Summary
The purpose of this single arm post-market observational study is to evaluate the short-term effectiveness of the Simeox 200 airway clearance device in improving airway clearance in adult patients aged 18 to 85 with bronchiectasis and chronic mucus hypersecretion. The study aims to establish a baseline for wet sputum weight production using the Simeox 200 device. Additionally, the study aims to assess the short-term effects of Simeox 200 on various outcomes, including lung function, respiratory symptoms, and health-related quality of life. The study participants will undergo the following steps: 1. Baseline Visit (V0): Participants will attend a baseline visit for eligibility screening, consent, a physical exam, and baseline assessments of various relevant parameters such as lung function, SpO2, and Patient-Reported-Outcomes. 2. Treatment Sessions (V1): Participants will perform two supervised treatment sessions with the Simeox 200 device at the clinic, during which sputum will be collected and weighed. 3. Home Use : Participants will use the device at home twice daily for 2 weeks, recording their usage and symptoms in a daily electronic diary. 4. Final Clinic Visit (V2): Participants will return for a final clinic visit for repeat assessments. 5. Follow-up Phone Call (14 days after V2): Participants will receive a follow-up phone call to assess ongoing symptoms and health status.
Description
Airway clearance techniques (ACTs) are essential for removing excess bronchial secretions and preventing airway complications. However, their effectiveness relies on patient adherence and satisfaction. Simoex 200 is a novel airway clearance device that uses intermittent negative oscillating pressure to mobilize airway secretions from different parts of the lungs to central airways, facilitating expectoration. Preliminary studies in Europe on patients with chronic muco-obstructive lung diseases have demonstrated the effectiveness and good tolerance of previous generations of the device. This pi…
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Diagnosis of bronchiectasis confirmed by computed chest tomography (CT chest) performed within the prior 36 months 2. Persistent productive cough for which daily airway clearance therapy is prescribed. 3. Daily sputum production estimated at \> 1 tsp or 5 ml 4. Clinically stable on medical regimen with no pulmonary exacerbation in the past 4 weeks prior to study enrolment 5. Subject able to sign informed consent Exclusion Criteria: 1. Inability to cough forcefully and independently, as determined by the clinician 2. Ventilatory assistance with endotracheal tube, trach…
Interventions
- DeviceIntermittent intrapulmonary deflation
Two treatment sessions daily for two weeks
Location
- Medical University of South CarolinaCharleston, South Carolina