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Nasal Airflow to Modulate Dyspnea in Tracheostomized Patients (MODUS)

A

Assistance Publique - Hôpitaux de Paris

Status

Not yet enrolling

Conditions

Ventilated Patients

Treatments

Procedure: propeller fan (FAN)
Procedure: Nasal air puffs
Procedure: Installation of high flow humidified air cannula
Procedure: Baseline

Study type

Interventional

Funder types

Other

Identifiers

NCT07308171
APHP251423

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

24 participants in 1 patient group

Patients ventilated
Experimental group
Description:
Baseline ventilator settings under pressure support
Treatment:
Procedure: Baseline
Procedure: Installation of high flow humidified air cannula
Procedure: Nasal air puffs
Procedure: propeller fan (FAN)

Trial contacts and locations

0

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Central trial contact

Martin DRES, MD PhD

Data sourced from clinicaltrials.gov

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