Prospective Trial for the Evaluation of Safety, Tolerability and Efficacy of the Medical Device Simeox ® Compared to Traditional Respiratory Physiotherapy Techniques for Airway Secretion Clearance

Physio-Assist1 site in 1 country15 target enrollmentJuly 2014

ConditionsBroncho-degenerative Disease Chronic Obstructive Airway Disease Cystic Fibrosis Idiopathic Bronchiectasis Ciliary Dyskinesia Chronic Bronchitis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Broncho-degenerative Disease
Sponsor: Physio-Assist
Enrollment: 15
Locations: 1
Primary Endpoint: Safety of the simeox®
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine whether the medical device "simeox" is safe in the treatment of respiratory diseases, in comparison with traditional physiotherapy.

Registry

clinicaltrials.gov

Start Date

July 2014

End Date

September 2015

Last Updated

6 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Physio-Assist

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient over 18, male or female.
•Patient affected by broncho-degenerative disease, chronic obstructive airway disease, cystic fibrosis, idiopathic bronchiectasis, ciliary dyskinesia and/or chronic bronchitis.
•Hospitalization for a minimum of five days or a maximum of 8 days.
•Bronchial clearance is usually productive.
•FVC and / or FEV \<85% predicted, with stable lung function.
•Agreement to participate to the study and signature of the informed consent form
•Social security coverage.

Exclusion Criteria

•Patient infected with bacteria resistant to antibiotics.
•Bronchial clearance is not usually productive.
•Patient with contra-indication for physiotherapy bronchial clearance.
•Patient who received a lung transplant.
•Care requires more than 2 sessions of chest physiotherapy daily.
•Duration of mechanical ventilation \> 8h/day.
•Patient with an episode of hemoptysis during the month before inclusion.
•Patient with an episode of pneumothorax during the last month.
•Pregnant or lactating women.
•Patient with a disability and/or unwillingness to follow protocol requirements.