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Home Airway Clearance in Patients With Bronchiectasis (Home-Care Bronchiectasis)

NCT04742270 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-01-04

No results posted yet for this study

Summary

Bronchiectasis is a chronic multiple etiologies pulmonary disease characterized by permanent dilatation of the caliber of the bronchial tree territory with an alteration of mucociliary clearance. This alteration causes mucus retention and leads to infections and chronic bronchial inflammation. Respiratory physiotherapy is one of the cornerstones of the management of these patients, particularly to facilitate bronchial drainage. In patients with abundant bronchial secretions, it is recommended to carry out airway clearance sessions daily or several times a day, which represents a very significant burden of care. Moreover, access to respiratory physiotherapy care isn't always easy for patients due to geographical, time, or professional availability limitations. In addition, few professionals are trained in France for this specific care dedicated to chronic lung disease. Finally with this kind of remote formation and follow up, it may be more suitable for this at-risk patient population in the context of the COVID-19 pandemic situation (limitation of physical contact).

SIMEOX® (Physio-Assist, Aix en Provence, France) is an innovative medical device (CE medical mark) for bronchial tree drainage. The use of this device in autonomy by the patient requires however a specific initial training of a few sessions (3-5 sessions). Tele-physiotherapy could allow remote training of patients in the use of SIMEOX®. This SIMEOX® device used autonomously at home, could provide patients with a practical and efficient bronchial clearance technique.

The overall objective of this pilot study is to evaluate the use of SIMEOX® at home after education in its use by telecare for bronchial drainage in patients with bronchiectasis (non-cystic Fibrosis Bronchiectasis) and who have difficulty accessing usual respiratory physiotherapy sessions.

Conditions

  • Bronchiectasis Adult

Interventions

DEVICE

SIMEOX+ respiratory physiotherapy telecare

Every 10 days, the patient's expert physiotherapist will contact the patient by video-transmission or telephone call for motivational reinforcement and technical support in the use of the device. During these phone calls, a quick 3-question questionnaire will be administered to the patient to monitor events of hemoptysis, chest pain and clinical symptoms of gastroesophageal reflux disease: pyrosis.If patients report this type of event, the physiotherapist will inform the patient's physician for management at his/her discretion. The expert physiotherapist will also conduct this sessions in order to increase the patient's motivation and compliance to the device. In order to do this, he will identify (in collaboration with the patient), the patient's difficulties and obstacles and he will try to find solutions with him.

Sponsors & Collaborators

  • Icadom

    collaborator INDUSTRY

  • Physio-Assist

    lead INDUSTRY

Principal Investigators

  • Rebecca Hamidfar, MD · Grenoble university affiliated hospital : pneumology department

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-04
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04742270 on ClinicalTrials.gov