Clinical trial NCT06730217: Bronchial Clearance Carried Out With a Mechanical In-exsufflator vs. a Manual Respiratory Physiotherapy Technique in Hospitalized Elderly People
Official title: Bronchial Clearance Carried Out With a Mechanical In-exsufflator vs. a Manual Respiratory Physiotherapy Technique in Hospitalized Elderly People
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bronchial Congestion
Airway Clearance Impairment
Keywords: respiratory muscle
mechanical ventilators
bronchial congestion
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients aged 60 or over, hospitalized in intensive care or conventional medicine, with bronchial congestion associated with peak expiratory flow \< 180 L/min, justifying respiratory physiotherapy management.
* Montreal Cognitive Assessment (MoCA) score ≥ 26
* Able to give consent
* Membership of a Social Security scheme.

Exclusion Criteria:

* Neuromuscular pathologies
* Spinal cord injury patients
* Contraindication to the use of a mechanical insufflator:

  * history of bullous emphysema, surgical emphysema, pneumothorax - undrained,
  * recent barotrauma,
  * tracheoesophageal fistula,
  * bronchospasm,
  * hemodynamic instability,
* Refusal to participate.
* Inability to cough on command
* Pregnant and breast-feeding women
* Persons under curatorship, guardianship, deprivation of liberty or legal protection.

Primary outcomes:
measure: Variation in peak cough flow (PCF)
timeFrame: Day 1
measure: Variation in peak cough flow (PCF)
timeFrame: Day 2
Secondary outcomes:
measure: Forced Vital Capacity
timeFrame: Day 1
measure: Forced Vital Capacity
timeFrame: Day 2
measure: Maximum Inspiratory and Expiratory Pressure
timeFrame: Day 1
measure: Maximum Inspiratory and Expiratory Pressure
timeFrame: Day 2
measure: Maximal Expiratory Volume in 1 second
timeFrame: Day 1
measure: Maximal Expiratory Volume in 1 second
timeFrame: Day 2
measure: Bronchial obstruction
timeFrame: Day 1
measure: Bronchial obstruction
timeFrame: Day 2
measure: Discomfort
timeFrame: Day 1
measure: Discomfort
timeFrame: Day 2
measure: Dyspnea
timeFrame: Up to day 2
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Lyon
country: France
facility: HCL Hôpital Edouard Herriot
city: Lyon
country: France
facility: HCL Hôpital Louis Pradel
city: Lyon
country: France
facility: Hôpital Saint Joseph Saint Luc
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Claire Estenne
role: PRINCIPAL_INVESTIGATOR
References: