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Not yet recruiting NCT07308171

Nasal Airflow to Modulate Dyspnea in Tracheostomized Patients

No phase Interventional Ventilated Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Baseline, Installation of high flow humidified air cannula, Nasal air puffs, propeller fan (FAN).
Who it may be relevant to
Registry conditions: Ventilated Patients. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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

Primary outcome measures

  • Dyspnea [Time frame: minute 20]
Secondary outcome measures (4)
  • airway occlusion pressure [Time frame: minute 20]
  • end expiratory occlusion pressure [Time frame: minute 20]
  • respiratory electromyogram (EMG) [Time frame: minute 20]
  • tolerance [Time frame: minute 20]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07308171 · APHP251423

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗