Bronchial Clearance Carried Out With a Mechanical In-exsufflator vs. a Manual Respiratory Physiotherapy Technique in Hospitalized Elderly People

NCT06730217 | Not Yet Recruiting

• 2 other identifiers: RBHP 2024 ESTENNE2024-A01839-38
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

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.

Conditions

Bronchial Congestion; Airway Clearance Impairment

Keywords

respiratory muscle; mechanical ventilators; bronchial congestion

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (11)

• Forced Vital Capacity

  Day 1

• Forced Vital Capacity

  Day 2

• Maximum Inspiratory and Expiratory Pressure

  Day 1

• Maximum Inspiratory and Expiratory Pressure

  Day 2

• Maximal Expiratory Volume in 1 second

  Day 1

Study Arms (2)

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.

Other: Control : standard care

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).

Device: Intervention : mechanical insufflator

Interventions

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).

Also known as: Device

Experimental

Control : standard care OTHER

Participants randomized to the control group will receive standard care

Control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 60 or over, hospitalised in intensive care units or general medical wards, with bronchial congestion and a peak expiratory flow \< 180 L/min, requiring respiratory physiotherapy
• Montreal Cognitive Assessment (MoCA) score ≥ 26
• Able to provide informed consent
• Affiliated with social health insurance

You may not qualify if:

• Neuromuscular disorders
• Spinal cord injury
• Contraindications to the use of mechanical insufflation-exsufflation:
• History of bullous emphysema, surgical emphysema, or undrained pneumothorax
• Recent barotrauma
• Tracheoesophageal fistula
• Bronchospasm
• Hemodynamic instability
• Refusal to participate.
• Inability to cough on command
• Pregnant or breastfeeding women
• People under protective legal measures

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (4)

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Location

HCL Hôpital Edouard Herriot

Lyon, France

Location

HCL Hôpital Louis Pradel

Lyon, France

Location

Hôpital Saint Joseph Saint Luc

Lyon, France

Location

Related Publications (1)

• 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.

  PMID: 41093324 DERIVED

MeSH Terms

Interventions

Equipment and Supplies

Study Officials

• Claire Estenne

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 12, 2024
• Study Start: December 15, 2025
• Primary Completion (Estimated): September 18, 2028
• Study Completion (Estimated): September 18, 2028
• Last Updated: November 25, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)