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.
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
- Conditions the study is for
- Bronchial Congestion, Airway Clearance Impairment
- 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
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.
- Conditions
- Bronchial Congestion, Airway Clearance Impairment
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Device: Intervention : mechanical insufflator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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
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
Maximum Inspiratory and Expiratory Pressure
This outcome will be assess by an electronic spirometer in cmH2O
Measured: Day 1
Maximum Inspiratory and Expiratory Pressure
This outcome will be assess by an electronic spirometer in cmH2O
Measured: Day 2
Maximal Expiratory Volume in 1 second
This outcome will be assess by an electronic spirometer in percentage.
Measured: Day 1
Maximal Expiratory Volume in 1 second
This outcome will be assess by an electronic spirometer in percentage.
Measured: 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).
Measured: 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).
Measured: Day 2
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
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
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.
- First posted12 Dec 2024
- Study start15 Dec 2025 (estimated)
- Primary completion18 Sep 2028 (estimated)
- Study completion18 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchial CongestionStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Estenne, Principal investigator, University Hospital, Clermont-Ferrand
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchial Clearance Carried Out With a Mechanical In-exsufflator vs. a Manual Respiratory Physiotherapy Technique in Hospitalized Elderly People
- ClinicalTrials.gov ID
- NCT06730217
- Acronym / sponsor ID
- INEXPA2 / RBHP 2024 ESTENNE
- Conditions
- Bronchial Congestion, Airway Clearance Impairment
- Keywords
- respiratory muscle, mechanical ventilators, bronchial congestion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 18 Sep 2028 (estimated)
- Study completion
- 18 Sep 2028 (estimated)
- First posted
- 12 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Control : standard careParticipants 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. |
| Experimental | Experimental | Device: Intervention : mechanical insufflatorParticipants randomized to the intervention group will benefit from a mechanical insufflator during airway clearance sessions (EOVE-70®, Air Liquide Medical Systems France). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- Neuromuscular disorders
- Spinal cord injury
- Contraindications to the use of mechanical insufflation-exsufflation:
- Inability to cough on command
- Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention : mechanical insufflatorAlso: DeviceParticipants randomized to the intervention group will benefit from a mechanical insufflator during airway clearance sessions (EOVE-70®, Air Liquide Medical Systems France). | Device | Experimental |
| Control : standard careParticipants randomized to the control group will receive standard care | Other | Control |
Primary outcome
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.
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.
11 secondary outcomes
Forced Vital Capacity
Time frame: Day 1
Forced Vital Capacity
Time frame: Day 2
Maximum Inspiratory and Expiratory Pressure
Time frame: Day 1
Maximum Inspiratory and Expiratory Pressure
Time frame: Day 2
Maximal Expiratory Volume in 1 second
Time frame: Day 1
Maximal Expiratory Volume in 1 second
Time frame: Day 2
Bronchial obstruction
Time frame: Day 1
Bronchial obstruction
Time frame: Day 2
Discomfort
Time frame: Day 1
Discomfort
Time frame: Day 2
Dyspnea
Time frame: Up to day 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Derived from this study: PubMed 41093324Estenne 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claire Estenne principal investigator
University Hospital, Clermont-Ferrand
4 sites in 1 country: see every site and its status.
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.