Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07308171

Nasal Airflow to Modulate Dyspnea in Tracheostomized Patients

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Ventilated Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Tracheostomy and mechanical ventilation
  • Dyspnea ≥3
  • Consent to participate
  • Affiliation to health insurance

Exclusion criteria

  • Agitation, delirium
  • Continuous use of sedatives
  • Patients under law protection
  • Inmates
  • Patients without health insurance
  • Breastfeeding and pregnancy

Treatment and study plan

baseline

Procedure

patient ventilated through the tracheostomy with initial ventilator settings

Installation of high flow humidified air cannula

Procedure

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

Nasal air puffs

Procedure

Nasal air puffs synchronized with the inspiratory time of the ventilator

propeller fan (FAN)

Procedure

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

Primary outcomes

  1. Dyspnea

    Time frame: minute 20

    visual analogical scale

Secondary outcomes

  1. airway occlusion pressure

    Time frame: minute 20

    visual analogical scale

  2. end expiratory occlusion pressure

    Time frame: minute 20

    visual analogical scale

  3. respiratory electromyogram (EMG)

    Time frame: minute 20

    visual analogical scale

  4. tolerance

    Time frame: minute 20

    visual analogical scale

Study contacts

Contact information is provided by the study sponsor or research team.

Martin DRES, MD PhD

CONTACT

[email protected]

+33142167809

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: MODUS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 29, 2025
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.