Nasal Airflow to Modulate Dyspnea in Tracheostomized Patients
MODUS
1 other identifier
interventional
24
0 countries
N/A
Brief 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 patients dependent on mechanical ventilation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2025
CompletedFirst Posted
Study publicly available on registry
December 29, 2025
CompletedStudy Start
First participant enrolled
February 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
January 29, 2026
January 1, 2026
1 year
December 15, 2025
January 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dyspnea
visual analogical scale
minute 20
Secondary Outcomes (4)
airway occlusion pressure
minute 20
end expiratory occlusion pressure
minute 20
respiratory electromyogram (EMG)
minute 20
tolerance
minute 20
Study Arms (1)
Patients ventilated
EXPERIMENTALBaseline ventilator settings under pressure support
Interventions
patient ventilated through the tracheostomy with initial ventilator settings
Installation of high flow humidified air cannula with inspired oxygen fraction (FiO2) 21%
Nasal air puffs synchronized with the inspiratory time of the ventilator
Stand-alone fan at the bedside directed toward the face of the patient
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Tracheostomy and mechanical ventilation
- Dyspnea ≥3
- Consent to participate
- Affiliation to health insurance
You may not qualify if:
- Agitation, delirium
- Continuous use of sedatives
- Patients under law protection
- Inmates
- Patients without health insurance
- Breastfeeding and pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Dres, MD PhD
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2025
First Posted
December 29, 2025
Study Start
February 1, 2026
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
January 29, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
- Access Criteria
- Researchers who provide a methodologically sound proposal.
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