Clinical trial NCT04742270: Home Airway Clearance in Patients With Bronchiectasis (Home-Care Bronchiectasis)
Official title: Feasibility of Implementing SIMEOX® Using Tele-physiotherapy and Evaluation of Compliance With SIMEOX® at Home for Bronchial Drainage in Patients With Bronchiectasis Other Than Cystic Fibrosis and Who Have Difficulties in Accessing Regular Respiratory Physiotherapy Sessions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiectasis Adult
Keywords: Airway Clearance
Bronchiectasis
Respiratory Physiotherapy Telecare
Lead sponsor: Physio-Assist
Sponsor class: INDUSTRY
Collaborators: name: Icadom
First posted: 2021-02-08
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: There is no comparison procedure included in this feasibility trial. Patients will be their own control.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Bronchiectasis is a chronic multiple etiologies pulmonary disease characterized by permanent and abnormal dilatation of the caliber of a territory of the bronchial tree with an alteration of mucociliary clearance. Patients with bronchiectasis have chronic cough and sputum production. Bacterial infections develop in them, leading to loss of lung function. Bronchiectasis affects patients of all ages and sexes, but the prevalence is higher in older women. It is often a complication of a previous lung infection or injury or is due to underlying systemic diseases. The treatment of bronchiectasis is multimodal and non-specific, including anti-inflammatory agents, bronchodilation, and depending on the clinical picture, bronchodilators, and inhaled antibiotics.

Respiratory physiotherapy is one of the cornerstones to facilitate bronchial drainage. In patients with abundant bronchial secretions, it is recommended that bronchial drainage sessions be performed daily or several times a day. These bronchial drainage sessions, whether performed with a physiotherapist or independently, represent a very significant burden of care with limited compliance. Moreover, access to respiratory physiotherapy care is not always easy for patients due to geographical, time or professional availability limitations. Telehealth is recommended to improve the access to care and the quality of care. The Article 53 of French Law No. 2019-774 of July 24, 2019, relating to the organization and transformation of the healthcare system, provides for telecare. In the context of respiratory physiotherapy, this is a session carried out remotely by the physiotherapist, by videotransmission. In the context of the COVID-19 health crisis, this telecare was regulated by the decree of May 11, 2020. The rehabilitation of respiratory diseases (excluding emergencies) was envisaged in this decree. Practical experiences of telecare in respiratory physiotherapy have emerged during this health crisis and have created an opportunity to facilitate access to care for patients.

The general principle expected from bronchial clearance techniques is to modify the viscoelastic properties of secretions and facilitate their elimination; these techniques can be applied simply with the spontaneous breathing of the patient by modifying the respiratory flow and/or the amplitude of ventilation or they can be applied with instrumental aids. SIMEOX® (Physio-Assist, Aix en Provence, France) is an innovative medical device (CE medical mark) for drainage of the bronchial tree: by means of a mouthpiece connected to SIMEOX® a succession of very short air negative pressure are generated in a non-invasive way that disseminate in the bronchial tree a pneumatic vibratory signal that modifies the rheological properties of the mucus, facilitates the mobilization of secretions and assists their transport to the upper airways. The SIMEOX® device was tested in patients with bronchiectasis during respiratory exacerbation during a 7-day hospital stay; patients reported good tolerance of the device; respiratory function and exercise tolerance parameters were improve. However, the patient's autonomous use of this device requires specific training of a few sessions (3 to 5 sessions).

RESEARCH HYPOTHESES Tele-physiotherapy could allow remote training of patients in the use of SIMEOX®. Once trained in its use, patients who have difficulty accessing standard respiratory physiotherapy sessions could be provided with a practical and effective bronchial clearance technique that can be used independently at home.

Eligibility criteria: Inclusion Criteria:

* Patient with a diagnosis of bronchiectasis confirmed by HR CT scan, regardless of etiology except cystic fibrosis and with estimated bronchorrhea \>10mL/d.
* Disease stability, defined as a delay of at least 4 weeks since the end of an exacerbation (end of antibiotic therapy or judged as resolved by the investigator).
* Age \> 18 years old
* Patient does not have access to a physiotherapist or does not usually go to a physiotherapy office (\<1/week on average)

Exclusion Criteria:

* Pneumothorax or severe hemoptysis (more than 30 ml per 24 hours) within 6 weeks before inclusion,
* Patient on transplant list
* Any contraindication to an instrumental bronchial clearance technique (at the discretion of the investigator)
* Patient not available or wishing to change of region within 3 months of inclusion
* Patient is currently participating or has participated within one month prior to inclusion in another clinical intervention research study that may impact the study, the impact of which is at the discretion of the investigator.
* Persons referred to in articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons: pregnant woman (verified by the dosage of β-HCG for any woman wishing to participate in the protocol and of childbearing age \< 60 years), parturient, breastfeeding mother, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure)

Primary outcomes:
measure: Compliance
timeFrame: 3 months after inclusion
Secondary outcomes:
measure: Compliance reliability
timeFrame: 3 months after inclusion
measure: Device use
timeFrame: 3 months after inclusion
measure: Device satisfaction
timeFrame: 3 months after inclusion
measure: General compliance
timeFrame: At inclusion
measure: Link between compliance to treatment and Physical activity
timeFrame: At inclusion and 3 months after
measure: Poor compliance factors
timeFrame: At inclusion
measure: Sputum collection feasability
timeFrame: 3 months after inclusion
measure: Quality of session
timeFrame: 3 months after inclusion
measure: Tele-physiotherapy feasability
timeFrame: 3 months after inclusion
measure: Specific quality of life
timeFrame: At inclusion and 3 months after
measure: Global quality of life
timeFrame: At inclusion and 3 months after
measure: Cough perception
timeFrame: At inclusion and 3 months after
measure: Bronchial clearance perception
timeFrame: At inclusion and 3 months after
measure: Respiratory function :Variation of forced expiratory volume in 1 second (FEV1)
timeFrame: At inclusion and 3 months after
measure: Respiratory function :Pulmonary forced vital capacity (FVC)
timeFrame: At inclusion and 3 months after
measure: Respiratory function :FEV1/ FVC ratio
timeFrame: At inclusion and 3 months after
measure: Respiratory function : Forced Expiratory Flow (FEF)
timeFrame: At inclusion and 3 months after
measure: Exacerbation
timeFrame: 3 months after inclusion
measure: First exacerbation onset
timeFrame: 3 months after inclusion
measure: Adverse events
timeFrame: 3 months after inclusion
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble University-Affiliated Hospital : Pneumology department
city: Nice
country: France
facility: Nice university-affiliated hospital : pneumonoly department
city: Toulouse
country: France
facility: Toulouse University-Affiliated Hospital : Pneumology department
Study officials:
affiliation: Grenoble university affiliated hospital : pneumology department
name: Rebecca Hamidfar, MD
role: PRINCIPAL_INVESTIGATOR
References: