Comparing High Flow Nasal Oxygen to Conventional Oxygen Therapy for Severe Breathing Problems
Efficacy of High Flow Nasal Oxygen Therapy Started in the Emergency Room Versus Conventional Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Distress
NA · Centre Hospitalier Universitaire de Besancon · NCT04607967
This study tests whether High Flow Nasal Oxygen works better than regular oxygen therapy for adults with severe breathing problems.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Besancon (other) |
| Locations | 10 sites (Dijon, Bourgogne and 9 other locations) |
| Trial ID | NCT04607967 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of High Flow Nasal Oxygen (HFNO) compared to conventional oxygen therapy in patients suffering from acute hypoxemic respiratory distress. Patients over 18 years old who exhibit severe hypoxemia and respiratory distress will be enrolled in the study. The trial aims to determine which oxygen delivery method provides better outcomes in terms of respiratory function and overall patient recovery. The study will be conducted in multiple emergency departments, ensuring a diverse patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old admitted to the emergency department with acute respiratory distress and low oxygen saturation.
Not a fit: Patients with hypercapnic respiratory failure or those requiring immediate mechanical ventilation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for patients experiencing acute respiratory distress, potentially saving lives.
How similar studies have performed: Previous studies have shown promising results with HFNO in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 18 years of age * Admitted to the Emergency Department for acute respiratory distress : * Respiratory rate ≥ at 25 cycles/min. * And SpO2 ≤ at 95% without or with oxygen whatever the mode. * And clinical signs of respiratory distress (pulling, thoraco-abdominal swinging). * And PaO2/FIO2 ratio \< 300mmHg. Exclusion Criteria: * Hypercapnic patients (PaCO2 \> 45mmHg) with respiratory acidosis (pH\<7.30). * Indication for non-invasive ventilation or early invasive mechanical ventilation according to current scientific recommendations (acute pulmonary edema, Chronic obstructive pulmonary disease decompensation, or others). * Dyspnea of traumatic origin. * Traumatic pneumothorax. * Hemodynamic instability (PAM\<65mmHg). * Patients treated with Mobile Emergency and Resuscitation Service (SMUR) who have already received cardiac or pulmonary treatment. * Patients with cognitive deterioration (Glasgow score less than 13, dementia or mental failure that would prevent good cooperation). * Patients with lesion(s) of the oro-nasal sphere contraindicated for the implementation of High Flow Nasal Oxygen Therapy. * Subject unlikely to cooperate in the study and/or low cooperation anticipated by the investigator. * Subject without health insurance. * Pregnant woman. * Subject being in the exclusion period of another study or included in the "national volunteer file".
Where this trial is running
Dijon, Bourgogne and 9 other locations
- University Hospital of Dijon — Dijon, Bourgogne, France (RECRUITING)
- University Hospital of Besançon — Besançon, Franche Comté, France (RECRUITING)
- Hospital of Chartres — Chartres, France (RECRUITING)
- University Hospital of Clermont Ferrand — Clermont-Ferrand, France (RECRUITING)
- Montpellier University Hospital — Montpellier, France (RECRUITING)
- University Hospital of Lariboisière — Paris, France (RECRUITING)
- University Hospital of Poitiers — Poitiers, France (RECRUITING)
- University Hospital of Rennes — Rennes, France (RECRUITING)
- University Hospital of Toulouse — Toulouse, France (RECRUITING)
- Hospital of Vesoul — Vesoul, France (RECRUITING)
Study contacts
- Study coordinator: Abdo Khoury, MD, MPH, MSc
- Email: akhoury@chu-besancon.fr
- Phone: 33 3 81 66 88 36
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: Acute Hypoxemic Respiratory Distress