Bronchial Clearance Carried Out With a Mechanical In-exsufflator vs. a Manual Respiratory Physiotherapy Technique in Hospitalized Elderly People (INEXPA2)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Airway Clearance Impairment; Bronchial Congestion
• Intervention / Treatment: Other: Control : standard care; Device: Intervention : mechanical insufflator

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lise Laclautre; Phone Number: 334.73.754.963; Email: promo_interne_drci@chu-clermontferrand.fr

Study Locations

• France
  • Clermont-Ferrand, France
    • CHU de Clermont-Ferrand
    • Principal Investigator: Claire Estenne
    • Contact: Lise Laclautre
  • Lyon, France
    • Hôpital Saint Joseph Saint Luc
    • Principal Investigator: Emmanuel Vivier
    • Contact: Lise Laclautre
  • Lyon, France
    • HCL Hopital Edouard Herriot
    • Contact: Lise Laclautre
    • Principal Investigator: Laurent Atgaud
  • Lyon, France
    • HCL Hôpital Louis Pradel
    • Contact: Lise Laclautre
    • Principal Investigator: Jésus Callabuig Lopez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; 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 control group will receive 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; Participants randomized to the intervention group will benefit from a mechanical insufflator during airway clearance sessions (EOVE-70®, Air Liquide Medical Systems France).; Other Names: Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Claire Estenne, University Hospital, Clermont-Ferrand

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2025
• Primary Completion (Estimated): September 18, 2028
• Study Completion (Estimated): September 18, 2028

Study Registration Dates

• First Submitted: November 29, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): December 12, 2024

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: respiratory muscle; mechanical ventilators; bronchial congestion
• Additional Relevant MeSH Terms: Equipment and Supplies
• Other Study ID Numbers: RBHP 2024 ESTENNE; 2024-A01839-38 (Other Identifier: 2024-A01839-38)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No