AzTrials
AzTrials

Bronchial CongestionINEXPA2NCT06730217

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

A study testing Intervention : mechanical insufflator in people with Bronchial Congestion and Airway Clearance Impairment, run by University Hospital, Clermont-Ferrand at 4 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
Intervention : mechanical insufflator
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
4 sitesFrance
Study dates
15 Dec 2025to 18 Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • Bronchospasm
  • Hemodynamic instability
  • Refusal to participate.
  • Inability to cough on command
  • Pregnant or breastfeeding women
  • People under protective legal measures

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

France4 sites
  • CHU de Clermont-Ferrand

    Clermont-Ferrand

    Lise Laclautre

    Claire Estenne

  • HCL Hôpital Edouard Herriot

    Lyon

    Lise Laclautre

    Laurent Atgaud

  • HCL Hôpital Louis Pradel

    Lyon

    Lise Laclautre

    Jésus Callabuig Lopez

  • Hôpital Saint Joseph Saint Luc

    Lyon

    Lise Laclautre

    Emmanuel Vivier

Other trials in France

About this study

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.

Read more

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.

Being tested
Intervention : mechanical insufflator, Control : standard care
Keywords
respiratory muscle, mechanical ventilators, bronchial congestion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention : mechanical insufflatorDevice

    Also called Device

    Participants randomized to the intervention group will benefit from a mechanical insufflator during airway clearance sessions (EOVE-70®, Air Liquide Medical Systems France).

  • Control : standard careOther

    Participants randomized to the control group will receive standard care

Study groups in NCT06730217
Study groupRoleWhat they receive
ControlActive comparatorParticipants 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.
Receives: Other: Control : standard care
ExperimentalExperimentalParticipants randomized to the intervention group will benefit from a mechanical insufflator during airway clearance sessions (EOVE-70®, Air Liquide Medical Systems France).
Receives: Device: Intervention : mechanical insufflator

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 1

  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.

    Measured: Day 2

Secondary outcomes (11)
  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.

    Measured: Day 1

  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.

    Measured: Day 2

  3. Maximum Inspiratory and Expiratory Pressure

    This outcome will be assess by an electronic spirometer in cmH2O

    Measured: Day 1

  4. Maximum Inspiratory and Expiratory Pressure

    This outcome will be assess by an electronic spirometer in cmH2O

    Measured: Day 2

  5. Maximal Expiratory Volume in 1 second

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

    Measured: Day 1

  6. Maximal Expiratory Volume in 1 second

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

    Measured: Day 2

  7. Bronchial obstruction

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

    Measured: Day 1

  8. Bronchial obstruction

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

    Measured: Day 2

  9. Discomfort

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

    Measured: Day 1

  10. Discomfort

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

    Measured: Day 2

  11. Dyspnea

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

    Measured: Up to day 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2024
  2. Study start15 Dec 2025 (estimated)
  3. Primary completion18 Sep 2028 (estimated)
  4. Study completion18 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Care provider
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06730217
Sponsor's protocol ID
RBHP 2024 ESTENNE
Other IDs
2024-A01839-38
Acronym
INEXPA2
Status last verified
Nov 2024
First submitted
29 Nov 2024
Last updated
25 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 41093324

Questions about this trial

What is this clinical trial studying?

A study testing Intervention : mechanical insufflator in people with Bronchial Congestion and Airway Clearance Impairment, run by University Hospital, Clermont-Ferrand at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Variation in peak cough flow (PCF) (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06730217, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in