Acoustic and Volumetric Measurements in Order to Objectify Bronchial Congestion in Patients With Obstructive Respiratory Pathologies Within the Framework of Their Management in Respiratory Physiotherapy for Decongestion

NCT05480163 | Unknown

• 2 other identifiers: MUKROBS2021-A02143-38
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease defined by permanent airway obstruction. In this disease, a large part of the muscular work is taken up by breathing (fight against bronchial, parietal or fibrous resistances of the pulmonary tissue, reduction of the exchange surface), requiring a physiotherapeutic care. Physiotherapy management of "respiratory rehabilitation" includes 4 items: respiratory therapy for decongestion, muscle strengthening, improvement of endurance and therapeutic education. In this context, the techniques of de-cluttering aim to decrease the hydrodynamic resistance of the bronchial tree. A systematic evaluation of the patient's condition is carried out by the practitioners to assess, at the time of the session, the bronchial congestion. In addition to their knowledge of the history of the patient they are following and the result of the oximetry measurement, practitioners use several indicators to assess the patient's bronchial congestion and define their therapeutic approach: cough, sputum, oximetry and peak expiratory flow, pulmonary auscultation. Sound expertise remains delicate: even the most educated human auditory system is not physiologically capable of detecting some of the relevant information. The current quantification criteria are therefore not very objective, depend on the practitioner's expertise and do not allow recommendations to be made on the conduct of the session during the follow-up of patients. Consequently, the objectification of bronchial congestion is clearly part of the process of improving management. In this context, the MUKROBS project seeks to objectify the bronchial congestion of COPD patients during their management by means of respiratory physiotherapy techniques of de-congestion by means of expiratory flow modulation techniques. The Sybille device, designed, developed and validated in the framework of a previous project funded by the ANR VirtualChest, allows continuous, non-invasive and simultaneous measurements of sound and displacement information at specific points of the thoracic cage.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• Scoring of respiratory congestion

  Comparison of the scoring of respiratory congestion status assessed by expert physiotherapists and by the Sybille device.

  75 minutes

Secondary Outcomes (7)

• Respiratory volumes in COPD group

  75 minutes

• Volumes calculated from the displacements

  75 minutes

• Respiratory volumes in control group

  40 minutes

• Volumes calculated in control group

  40 minutes

• Rates by type of breath sounds

  75 minutes

Study Arms (2)

Measurement records in COPD patients

EXPERIMENTAL

1. The subject is informed of the procedure, his or her rights, and the use of the data collected (including the video recording of the session) 2. Pre-session clinical assessment by the physiotherapist 3. Installation of the Sybille waistcoat on the patient 4. First measurement phase: Recording of spirometry parameters, acoustics, movements (thoracic volumetry) for forced vital capacity (FVC) and LVC manoeuvres. 5. Second phase of measurements: Treatment: the physiotherapist performs the session in the classical way. Recording of acoustic parameters, movements (thoracic volumetry). 6. Third phase of measurements: Recording of spirometry, acoustics and movement parameters (thoracic volumetry) for FVC and LVC manoeuvres. 7. Removal of measurement devices 8. Post session evaluation by the physiotherapist.

Other: Measurement records

Measurement records in control subject

OTHER

1. The subject is informed of the procedure, his or her rights, and the use of the data collected (including the video recording of the session) 2. Clinical assessment by the physiotherapist The subject answers the questionnaire 3. Installation of the Sybille waistcoat on the patient 4. Measurement phase: Recording of spirometry, acoustics, movements (thoracic volumetry) for FVC and LVC manoeuvres. 5. Removal of measurement devices

Other: Measurement records

Interventions

Measurement records OTHER

Recordings of spirometry, acoustics, movement (chest volumetry) parameters for FVC and LVC exercises.

Measurement records in COPD patients; Measurement records in control subject

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Control group
• Patient with no known respiratory pathology and a normal forced expiratory volume at one second (FEV1) /FVC ratio normal for age and sex (chart).
• COPD group
• Patients diagnosed with COPD, post exacerbations and/or post hospitalisation with chronic congestion

You may not qualify if:

• Control group
• Smoker or former smoker (less than 6 years of cessation)
• Prolonged or repeated exposure to gases, dusts, fumes, vapours in the context of professional activities
• Respiratory pathology
• Pacemaker or heart battery wearers
• Cognitive disorders that do not allow for informed consent
• Prostheses or metallic materials (vascular clip, neuro-stimulator, insulin pump, various implants, etc.)
• Chest pain context
• Spinal orthopaedic disorders not compatible with the device (cypho scoliosis etc...)
• Opposition of the patient
• BMI \>30
• History of hospitalization for coronavirus
• COPD group :
• Refusal to transfer image rights
• Haemoptysis

Sponsors & Collaborators

• Association des Réseaux Bronchiolite: lead
• Laboratoire Système et Matériaux pour la Mécatronique (SYMME): collaborator

Study Sites (2)

Physiotherapy practice of Mr TORRES

Annecy, France

RECRUITING

Physiotherapy practice of Mr. Jean-Charles LAPORTE

Paris, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Didier EVENOU

CONTACT

0660946700; devenou@orange.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: UNKNOWN
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 29, 2022
• Study Start: June 18, 2022
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2023
• Last Updated: July 29, 2022

Record last verified: 2022-07

Locations

FR (2)