Using Nasal High Flow therapy for patients with acute respiratory failure
Contribution of Nasal High Flow in Pneumology Assessed in Acid-Free Hypercapnic Acute Respiratory Failure
NA · Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · NCT06008587
This study is testing if adding Nasal High Flow therapy can help adults with acute respiratory failure breathe better and feel more comfortable compared to just standard treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer (other) |
| Locations | 3 sites (Cannes, Alpes Maritime and 2 other locations) |
| Trial ID | NCT06008587 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of Nasal High Flow therapy in patients experiencing hypercapnic acute respiratory failure without acidosis, compared to those receiving only standard treatment. The primary objective is to demonstrate that adding Nasal High Flow improves patient outcomes, including respiratory rate, dyspnea, gas exchange, and overall comfort. Secondary objectives include identifying characteristics of patients who respond to this treatment and analyzing the length of hospital stays. The study will involve patients aged 18 and older who meet specific criteria related to their respiratory condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with acute respiratory failure characterized by elevated carbon dioxide levels without acidosis.
Not a fit: Patients with restrictive chronic respiratory conditions or those requiring non-invasive ventilation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the management of acute respiratory failure, leading to better patient outcomes and reduced hospital stays.
How similar studies have performed: Previous studies have shown promising results with Nasal High Flow therapy in similar respiratory conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Major patient ≥ 18 years old * Medical diagnosis of Acute Respiratory Failure less than 48 hours * With partial pressure of carbon dioxide (PaCO2) \> 45 and pH \> 7.35 for less than 48 hours, with no indication of Non-Invasive Ventilation (NIV) placement * Underlying terrain of known or unknown chronic respiratory pathology (may be unknown at time of diagnosis) Examples : COPD, Bronchiectasis, Pulmonary fibrosis, asthma, sequelae pathologies ... * All etiologies (infectious, cardiac decompensation, trauma, etc.) * Having given informed consent * Patient under a social security scheme * Possibility to include a patient having already been included in the study but suffering from a new episode of hypercapnic non acidic Acute Respiratory Failure Exclusion Criteria: * Restrictive chronic neuromuscular or kyphoscoliotic respiratory insufficiencies * Drug-induced Acute respiratory failure * Pneumothorax (X-ray pulmonary detachment) * Oxygen poisoning * Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (COVII) Pneumonia * Tracheostomy * Prior treatment with chronic or initiated NIV just prior to treatment (e.g. Intensive Care Unit) * Respiratory Severity Criteria for Resuscitation Management * Agitation or non-cooperation * Pregnancy or breastfeeding * Person participating in other biomedical research * Any other reason that the investigator believes may interfere with the evaluation of the study objectives * Person under judicial protection (guardianship, curatorship) * Person deprived of liberty by a judicial or administrative decision
Where this trial is running
Cannes, Alpes Maritime and 2 other locations
- Centre Hospitalier de Cannes — Cannes, Alpes Maritime, France (TERMINATED)
- Centre Hospitalier Intercommunal de Toulon- La Seyne sur Mer - Hôpital Sainte Musse — Toulon, Var, France (RECRUITING)
- Centre Hospitalier Princesse Grace — Monaco, Monaco (RECRUITING)
Study contacts
- Study coordinator: Magali CESANA
- Email: magali.cesana@ch-toulon.fr
- Phone: 0494145525
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Respiratory Insufficiency, Nasal High Flow, Acute Respiratory Failure, Respiratory non-acidosis, Pneumology, Hypercapnia