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Nasal Airflow to Modulate Dyspnea in Tracheostomized Patients

Nasal Airflow to Modulate Dyspnea in Tracheostomized Patients

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07308171
Acronym
MODUS
Enrollment
24
Registered
2025-12-29
Start date
2026-02-01
Completion date
2027-02-01
Last updated
2026-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilated Patients

Keywords

Mechanical ventilation, Tracheostomy, Nasal stimulation

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.

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.

Interventions

PROCEDUREBaseline

patient ventilated through the tracheostomy with initial ventilator settings

PROCEDUREInstallation of high flow humidified air cannula

Installation of high flow humidified air cannula with inspired oxygen fraction (FiO2) 21%

PROCEDURENasal air puffs

Nasal air puffs synchronized with the inspiratory time of the ventilator

PROCEDUREpropeller fan (FAN)

Stand-alone fan at the bedside directed toward the face of the patient

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Dyspneaminute 20visual analogical scale

Secondary

MeasureTime frameDescription
end expiratory occlusion pressureminute 20visual analogical scale
respiratory electromyogram (EMG)minute 20visual analogical scale
toleranceminute 20visual analogical scale
airway occlusion pressureminute 20visual analogical scale

Contacts

CONTACTMartin DRES, MD PhD
martin.dres@aphp.fr+33142167809
PRINCIPAL_INVESTIGATORMartin Dres, MD PhD

Assistance Publique - Hôpitaux de Paris

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026