Ventilated PatientsMODUSNCT07308171
Nasal Airflow to Modulate Dyspnea in Tracheostomized Patients
A study testing Baseline, Installation of high flow humidified air cannula and Nasal air puffs in people with Ventilated Patients, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The hypothesis of the present study is that restoring nasal stimulation alleviates dyspnea and improves respiratory drive. The aim of this study is to compare three non-pharmacological approaches designed to restore nasal stimulation (continuous nasal airflow, nasal sprays, and facial airflow) in tracheotomized… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilated Patients
- What is being tested?
- Baseline, Installation of high flow humidified air cannula and Nasal air puffs
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 17 Feb 2026to Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Tracheostomy and mechanical ventilation
- Dyspnea ≥3
- Consent to participate
- Affiliation to health insurance
Who cannot join
- Agitation, delirium
- Continuous use of sedatives
- Patients under law protection
- Inmates
- Patients without health insurance
- Breastfeeding and pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Pitié Salpêtrière
Paris
Martin DRES, +33 01 42 16 78 09, martin.dres@aphp.com
About this study
The hypothesis of the present study is that restoring nasal stimulation alleviates dyspnea and improves respiratory drive. The aim of this study is to compare three non-pharmacological approaches designed to restore nasal stimulation (continuous nasal airflow, nasal sprays, and facial airflow) in tracheotomized patients dependent on mechanical ventilation.
Read the detailed description
Nasal stimulation is generated by breathing, which enables olfaction and helps to rhythm brain activity. The loss of nasal stimulation in tracheotomized patients who are dependent on mechanical ventilation may negatively affect respiratory drive and contribute to dyspnea. Restoring nasal airflow therefore emerges as an attractive non-pharmacological approach to treat dyspnea in patients undergoing mechanical ventilation weaning.
The hypothesis of the present study is that restoring nasal stimulation alleviates dyspnea and improves respiratory drive. The aim of this study is to compare three non-pharmacological approaches designed to restore nasal stimulation (continuous nasal airflow, nasal sprays, and facial airflow) in tracheotomized patients dependent on mechanical ventilation.
- Conditions
- Ventilated Patients
- Being tested
- Baseline, Installation of high flow humidified air cannula, Nasal air puffs, propeller fan (FAN)
- Keywords
- Mechanical ventilation, Tracheostomy, Nasal stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaselineProcedure or surgery
patient ventilated through the tracheostomy with initial ventilator settings
Installation of high flow humidified air cannulaProcedure or surgery
Installation of high flow humidified air cannula with inspired oxygen fraction (FiO2) 21%
Nasal air puffsProcedure or surgery
Nasal air puffs synchronized with the inspiratory time of the ventilator
propeller fan (FAN)Procedure or surgery
Stand-alone fan at the bedside directed toward the face of the patient
| Study group | Role | What they receive |
|---|---|---|
| Patients ventilated | Experimental | Baseline ventilator settings under pressure support Receives: Procedure: Baseline; Procedure: Installation of high flow humidified air cannula; Procedure: Nasal air puffs; Procedure: propeller fan (FAN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea
visual analogical scale
Measured: minute 20
Secondary outcomes (4)
airway occlusion pressure
visual analogical scale
Measured: minute 20
end expiratory occlusion pressure
visual analogical scale
Measured: minute 20
respiratory electromyogram (EMG)
visual analogical scale
Measured: minute 20
tolerance
visual analogical scale
Measured: minute 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start17 Feb 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilated PatientsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Dres, MD PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308171
- Sponsor's protocol ID
- APHP251423
- Acronym
- MODUS
- Status last verified
- Sep 2026
- First submitted
- 15 Dec 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Airflow to Modulate Dyspnea in Tracheostomized Patients
- ClinicalTrials.gov ID
- NCT07308171
- Acronym / sponsor ID
- MODUS / APHP251423
- Conditions
- Ventilated Patients
- Keywords
- Mechanical ventilation, Tracheostomy, Nasal stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 17 Feb 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 29 Dec 2025 (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.
The hypothesis of the present study is that restoring nasal stimulation alleviates dyspnea and improves respiratory drive. The aim of this study is to compare three non-pharmacological approaches designed to restore nasal stimulation (continuous nasal airflow, nasal sprays, and facial airflow) in tracheotomized patients dependent on mechanical ventilation.
Detailed description
Nasal stimulation is generated by breathing, which enables olfaction and helps to rhythm brain activity. The loss of nasal stimulation in tracheotomized patients who are dependent on mechanical ventilation may negatively affect respiratory drive and contribute to dyspnea. Restoring nasal airflow therefore emerges as an attractive non-pharmacological approach to treat dyspnea in patients undergoing mechanical ventilation weaning.
The hypothesis of the present study is that restoring nasal stimulation alleviates dyspnea and improves respiratory drive. The aim of this study is to compare three non-pharmacological approaches designed to restore nasal stimulation (continuous nasal airflow, nasal sprays, and facial airflow) in tracheotomized patients dependent on mechanical ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients ventilated | Experimental | Procedure: Baseline, Procedure: Installation of high flow humidified air cannula, Procedure: Nasal air puffs, Procedure: propeller fan (FAN)Baseline ventilator settings under pressure support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Tracheostomy and mechanical ventilation
- Dyspnea ≥3
- Consent to participate
- Affiliation to health insurance
Key exclusion criteria (6 listed)
- Agitation, delirium
- Continuous use of sedatives
- Patients under law protection
- Inmates
- Patients without health insurance
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 |
|---|---|---|
| Baselinepatient ventilated through the tracheostomy with initial ventilator settings | Procedure or surgery | Patients ventilated |
| Installation of high flow humidified air cannulaInstallation of high flow humidified air cannula with inspired oxygen fraction (FiO2) 21% | Procedure or surgery | Patients ventilated |
| Nasal air puffsNasal air puffs synchronized with the inspiratory time of the ventilator | Procedure or surgery | Patients ventilated |
| propeller fan (FAN)Stand-alone fan at the bedside directed toward the face of the patient | Procedure or surgery | Patients ventilated |
Primary outcome
Dyspnea
Time frame: minute 20
visual analogical scale
4 secondary outcomes
airway occlusion pressure
Time frame: minute 20
end expiratory occlusion pressure
Time frame: minute 20
respiratory electromyogram (EMG)
Time frame: minute 20
tolerance
Time frame: minute 20
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 29 Sep 2026.
- Individual participant dataSharing planned: Yes. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations
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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.
Martin Dres, MD PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline, Installation of high flow humidified air cannula and Nasal air puffs in people with Ventilated Patients, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Martin DRES, MD PhD (+33142167809, martin.dres@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea (time frame: minute 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2026.