Nasal Airflow to Modulate Dyspnea in Tracheostomized Patients

NCT ID: NCT07308171

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2027-02-28

Brief Summary

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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

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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.

Conditions

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Ventilated Patients

Keywords

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Mechanical ventilation Tracheostomy Nasal stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients

Baseline ventilator settings under pressure support

Group Type EXPERIMENTAL

Baseline

Intervention Type PROCEDURE

patient ventilated through the tracheostomy with initial ventilator settings

Installation of high flow humidified air cannula

Intervention Type PROCEDURE

Installation of high flow humidified air cannula with FiO2 21%

Nasal air puffs

Intervention Type PROCEDURE

Nasal air puffs synchronized with the inspiratory time of the ventilator

FAN

Intervention Type PROCEDURE

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

Interventions

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Baseline

patient ventilated through the tracheostomy with initial ventilator settings

Intervention Type PROCEDURE

Installation of high flow humidified air cannula

Installation of high flow humidified air cannula with FiO2 21%

Intervention Type PROCEDURE

Nasal air puffs

Nasal air puffs synchronized with the inspiratory time of the ventilator

Intervention Type PROCEDURE

FAN

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Dres, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Central Contacts

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Martin DRES, MD PhD

Role: CONTACT

Phone: +33142167809

Email: [email protected]

Other Identifiers

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APHP251423

Identifier Type: -

Identifier Source: org_study_id