An interventional study of Intervention : mechanical insufflator and Control : standard care in Bronchial Congestion and Airway Clearance Impairment, sponsored by University Hospital, Clermont-Ferrand. Not yet recruiting at 4 sites in France. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-11-25.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Supportive care
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.
University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Contraindications to the use of mechanical insufflation-exsufflation:
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.
Other: Control : standard care
Participants randomized to the intervention group will benefit from a mechanical insufflator during airway clearance sessions (EOVE-70®, Air Liquide Medical Systems France).
Device: Intervention : mechanical insufflator
Participants randomized to the intervention group will benefit from a mechanical insufflator during airway clearance sessions (EOVE-70®, Air Liquide Medical Systems France).
Also known as: Device
Participants randomized to the control group will receive standard care
Variation in peak cough flow (PCF)
The variation in peak cough flow (PCF) is expressed as a percentage change from the pre-session value.
Time frame: 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.
Time frame: Day 2
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.
Time frame: Day 1
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.
Time frame: Day 2
Maximum Inspiratory and Expiratory Pressure
This outcome will be assess by an electronic spirometer in cmH2O
Time frame: Day 1
Maximum Inspiratory and Expiratory Pressure
This outcome will be assess by an electronic spirometer in cmH2O
Time frame: Day 2
Maximal Expiratory Volume in 1 second
This outcome will be assess by an electronic spirometer in percentage.
Time frame: Day 1
Maximal Expiratory Volume in 1 second
This outcome will be assess by an electronic spirometer in percentage.
Time frame: 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).
Time frame: 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).
Time frame: Day 2
Discomfort
Session discomfort using a numerical scale (0 - no discomfort; 10 - very uncomfortable session); session discomfort will be measured after each session.
Time frame: Day 1
Discomfort
Session discomfort using a numerical scale (0 - no discomfort; 10 - very uncomfortable session); session discomfort will be measured after each session.
Time frame: Day 2
Dyspnea
This using the modified Borg scale (0-no shortness of breath; 10-maximum shortness of breath felt during the session).
Time frame: Up to day 2
Plan to share: No
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University Hospital, Clermont-Ferrand