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RecruitingNCT07308171MODUSUpdated Sep 29, 2026

Nasal Airflow to Modulate Dyspnea in Tracheostomized Patients

An interventional study of Baseline and Installation of high flow humidified air cannula in Ventilated Patients, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Ventilated Patients

Keywords

  • Mechanical ventilation
  • Tracheostomy
  • Nasal stimulation
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Patients ventilated

    Baseline ventilator settings under pressure support

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

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

05

What researchers measure

Primary outcomes

  1. Dyspnea

    visual analogical scale

    Time frame: minute 20

Secondary outcomes

  1. airway occlusion pressure

    visual analogical scale

    Time frame: minute 20

  2. end expiratory occlusion pressure

    visual analogical scale

    Time frame: minute 20

  3. respiratory electromyogram (EMG)

    visual analogical scale

    Time frame: minute 20

  4. tolerance

    visual analogical scale

    Time frame: minute 20

06

Study locations

1 of 1 sites recruiting
  • Hôpital Pitié Salpêtrière
    Paris, France
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes — 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

Supporting information: Study protocol, Icf

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07308171
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Dec 29, 2025
Start date
Feb 17, 2026
Primary completion
Feb 2028 (estimated)
Completion
Feb 2028 (estimated)
Last update
Sep 29, 2026

Study contacts

Martin DRES, MD PhD
Contact
martin.dres@aphp.fr
+33142167809
Martin Dres, MD PhD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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