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NCT Number: NCT06730217

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

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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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont-Ferrand, Clermont-Ferrand, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: Device

Control : standard care

Other

Participants randomized to the control group will receive standard care

Primary outcomes

  1. Variation in peak cough flow (PCF)

    Time frame: Day 1

    The variation in peak cough flow (PCF) is expressed as a percentage change from the pre-session value.

  2. Variation in peak cough flow (PCF)

    Time frame: Day 2

    The variation in peak cough flow (PCF) is expressed as a percentage change from the pre-session value.

Secondary outcomes

  1. Forced Vital Capacity

    Time frame: Day 1

    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.

  2. Forced Vital Capacity

    Time frame: Day 2

    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.

  3. Maximum Inspiratory and Expiratory Pressure

    Time frame: Day 1

    This outcome will be assess by an electronic spirometer in cmH2O

  4. Maximum Inspiratory and Expiratory Pressure

    Time frame: Day 2

    This outcome will be assess by an electronic spirometer in cmH2O

  5. Maximal Expiratory Volume in 1 second

    Time frame: Day 1

    This outcome will be assess by an electronic spirometer in percentage.

  6. Maximal Expiratory Volume in 1 second

    Time frame: Day 2

    This outcome will be assess by an electronic spirometer in percentage.

  7. Bronchial obstruction

    Time frame: Day 1

    This outcomme will be assess by an electronic spirometer with the Tiffenau index (Maximal expiratory volume in 1 second / Forced Vital Capacity).

  8. Bronchial obstruction

    Time frame: Day 2

    This outcomme will be assess by an electronic spirometer with the Tiffenau index (Maximal expiratory volume in 1 second / Forced Vital Capacity).

  9. Discomfort

    Time frame: Day 1

    Session discomfort using a numerical scale (0 - no discomfort; 10 - very uncomfortable session); session discomfort will be measured after each session.

  10. Discomfort

    Time frame: Day 2

    Session discomfort using a numerical scale (0 - no discomfort; 10 - very uncomfortable session); session discomfort will be measured after each session.

  11. Dyspnea

    Time frame: Up to day 2

    This using the modified Borg scale (0-no shortness of breath; 10-maximum shortness of breath felt during the session).

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

334.73.754.963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: INEXPA2

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 12, 2024
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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