Nasal Airflow to Modulate Dyspnea in Tracheostomized Patients (MODUS)

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 Overview

• Status: Not yet recruiting
• Conditions: Ventilated Patients
• Intervention / Treatment: Procedure: Baseline; Procedure: Nasal air puffs; Procedure: Installation of high flow humidified air cannula; Procedure: propeller fan (FAN)

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 Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martin DRES, MD PhD; Phone Number: +33142167809; Email: martin.dres@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years
2. Tracheostomy and mechanical ventilation
3. Dyspnea ≥3
4. Consent to participate
5. Affiliation to health insurance

Exclusion Criteria:

1. Agitation, delirium
2. Continuous use of sedatives
3. Patients under law protection
4. Inmates
5. Patients without health insurance
6. Breastfeeding and pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients ventilated; Baseline ventilator settings under pressure support

Procedure: Baseline; patient ventilated through the tracheostomy with initial ventilator settings; Procedure: Nasal air puffs; Nasal air puffs synchronized with the inspiratory time of the ventilator; Procedure: Installation of high flow humidified air cannula; Installation of high flow humidified air cannula with inspired oxygen fraction (FiO2) 21%; Procedure: propeller fan (FAN); Stand-alone fan at the bedside directed toward the face of the patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyspnea	visual analogical scale	minute 20

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
airway occlusion pressure	visual analogical scale	minute 20
end expiratory occlusion pressure	visual analogical scale	minute 20
respiratory electromyogram (EMG)	visual analogical scale	minute 20
tolerance	visual analogical scale	minute 20

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Martin Dres, MD PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Tracheostomy; Mechanical ventilation; Nasal stimulation
• Additional Relevant MeSH Terms: BaseLine dental cement
• Other Study ID Numbers: APHP251423

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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

• IPD Sharing 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
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No