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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A01839-38 | Other Identifier | 2024-A01839-38 |
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Everywhere in the world, life expectancy is increasing. Currently, most individuals can expect to live up to 60 years and beyond. In all countries, the number and proportion of older adult in the population are rising. By 2030, one in six people in the world will be 60 years old or older.
France is also seeing its population age, with the number of older people increasing from 14% in 2014 to 21% in 2022. In 2018, elderly people accounted for 30% of short-stay hospitalizations. One of the most common causes of hospitalization for older adult is respiratory system pathologies, second only to cardiovascular system pathologies. Admission for a respiratory pathology is often associated with bronchial congestion. Infectious or viral pneumonia is often the terminal illness for the older adult. In the United States, 1 million old patients are hospitalized for this pathology, and 30% of them will die within the year.
Old people are more susceptible to pneumonia due to several factors, including impaired gag reflex, reduced muco-ciliary function, weakened immunity, impaired fever response, and various degrees of cardiopulmonary dysfunction. Additionally, central nervous system disorders and/or impaired gag reflex increase the risk of aspiration pneumonia in old patients. The majority of these patients develop a productive cough, but unfortunately, their ability to cough effectively is often reduced.
Aging leads to various changes in the respiratory system. The thoracic cage and spine deform due to calcification and osteoporosis, resulting in stiffness. The thoracic wall stiffens, making mobilization more difficult and increasing the muscular work required for expansion during inspiration. The diaphragm is in a less favorable position to contract effectively. Expiration becomes less efficient, leading to an increase in residual volume (RV) and promoting what is called "senile emphysema," where air spaces dilate and dead spaces increase. This leads to an increase in functional residual capacity and RV, reducing vital capacity. Additionally, respiratory muscles lose strength due to muscle atrophy and decreased fast-twitch fibers. These mechanisms can compromise ventilation, mucus clearance, and cough effectiveness, all essential for preventing bronchial congestion.
The effectiveness of Mechanical Insufflation-Exsufflation (MI-E) in airway clearance has been demonstrated in children and adults with neuromuscular pathologies.
Since the respiratory function of old people may be similar to that of patients with neuromuscular pathologies due to age-related loss of respiratory capacity and cough strength, it would be interesting to specifically study the use of MI-E in this population. Our previous study (ClinicalTrials.gov Identifier: NCT05090696) showed that old people tolerated MI-E well (low discomfort and no changes in vital signs). After the first session of bronchial clearance with MI-E, dyspnea decreased significantly (median Borg scale before session = 2.8 versus after = 1.8, p = 0.004). Additionally, cough strength increased across all sessions (mean pre = 130 vs. post = 145, p = 0.005).
Following this initial study, the investigators wondered if the use of MI-E would be more effective than a session of manual physiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Participants randomized to the control group will receive standard care. The patient is then assessed by a first physiotherapist evaluator, who measures the data described in the study setting section. The physiotherapist then performs a manual bronchial decongestion session, using the Expiratory Flow Augmentation technique with abdominal and thoracic counter-pressure. |
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| Experimental | Experimental | Participants randomized to the intervention group will benefit from a mechanical insufflator during airway clearance sessions (EOVE-70®, Air Liquide Medical Systems France). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention : mechanical insufflator | Device | Participants randomized to the intervention group will benefit from a mechanical insufflator during airway clearance sessions (EOVE-70®, Air Liquide Medical Systems France). |
| Measure | Description | Time Frame |
|---|---|---|
| Variation in peak cough flow (PCF) | The variation in peak cough flow (PCF) is expressed as a percentage change from the pre-session value. | Day 1 |
| Variation in peak cough flow (PCF) | The variation in peak cough flow (PCF) is expressed as a percentage change from the pre-session value. | Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Forced Vital Capacity | This outcomme will be assessed by an electronic spirometer. This value is in absolute values (LBTPS/sec) and as a percentage, taking into account the patient's age, sex and height. | Day 1 |
| Forced Vital Capacity |
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Inclusion Criteria:
Exclusion Criteria:
Neuromuscular disorders
Spinal cord injury
Contraindications to the use of mechanical insufflation-exsufflation:
Inability to cough on command
Pregnant or breastfeeding women
People under protective legal measures
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise Laclautre | Contact | 334.73.754.963 | promo_interne_drci@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Claire Estenne | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont-Ferrand | Clermont-Ferrand | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41093324 | Derived | Estenne C, Dobija L, Pelletier-Visa M, Pereira B, Coudeyre E. Efficacy of using a mechanical insufflation-exsufflation versus manual respiratory physiotherapy on cough peak flow in hospitalised older adults in French hospitals: a protocol for a single-blind randomised clinical trial. BMJ Open. 2025 Oct 15;15(10):e105351. doi: 10.1136/bmjopen-2025-105351. |
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Participants randomized to the intervention group will benefit from a mechanical insufflator during airway clearance sessions (EOVE-70®, Air Liquide Medical Systems France). In this group, patients will also be assessed before and after each session, in order to compare the 2 chosen airway clearance techniques on variation in peak expiratory flow.
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| Control : standard care | Other | Participants randomized to the control group will receive standard care |
|
This outcomme will be assessed by an electronic spirometer. This value is in absolute values (LBTPS/sec) and as a percentage, taking into account the patient's age, sex and height.
| Day 2 |
| Maximum Inspiratory and Expiratory Pressure | This outcome will be assess by an electronic spirometer in cmH2O | Day 1 |
| Maximum Inspiratory and Expiratory Pressure | This outcome will be assess by an electronic spirometer in cmH2O | Day 2 |
| Maximal Expiratory Volume in 1 second | This outcome will be assess by an electronic spirometer in percentage. | Day 1 |
| Maximal Expiratory Volume in 1 second | This outcome will be assess by an electronic spirometer in percentage. | Day 2 |
| Bronchial obstruction | This outcomme will be assess by an electronic spirometer with the Tiffenau index (Maximal expiratory volume in 1 second / Forced Vital Capacity). | Day 1 |
| Bronchial obstruction | This outcomme will be assess by an electronic spirometer with the Tiffenau index (Maximal expiratory volume in 1 second / Forced Vital Capacity). | Day 2 |
| Discomfort | Session discomfort using a numerical scale (0 - no discomfort; 10 - very uncomfortable session); session discomfort will be measured after each session. | Day 1 |
| Discomfort | Session discomfort using a numerical scale (0 - no discomfort; 10 - very uncomfortable session); session discomfort will be measured after each session. | Day 2 |
| Dyspnea | This using the modified Borg scale (0-no shortness of breath; 10-maximum shortness of breath felt during the session). | Up to day 2 |
| HCL Hôpital Edouard Herriot | Lyon | France |
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| HCL Hôpital Louis Pradel | Lyon | France |
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| Hôpital Saint Joseph Saint Luc | Lyon | France |
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| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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