Effects of CPAP vs. High Flow Nasal Oxygen in ARDS Patients
Physiologic Effects of Two Non-invasive Respiratory Support Therapies (continuous Positive Airway Pressure Vs High Flow Nasal Oxygenation) in Patients with Acute Respiratory Distress Syndrome: a Randomized Clinical Trial.
This study is testing whether using CPAP or high flow nasal oxygen helps people with acute respiratory distress syndrome breathe better and recover faster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Hospital Clinic of Barcelona Academic / other |
| Locations | 1 site (Barcelona, Barcelona) |
| Trial ID | NCT06694311 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the physiological effects of continuous positive airway pressure (CPAP) compared to high flow nasal oxygenation (HFNO) in patients suffering from acute respiratory distress syndrome (ARDS). It is a multicenter, randomized, open-label, controlled trial involving 120 non-intubated patients who will receive either CPAP or HFNO for 48 hours alongside standard intensive care. The primary outcome is the assessment of lung injury through the biomarker sRAGE, while secondary outcomes include various pulmonary dysfunction biomarkers and intubation rates. The study aims to determine if CPAP can effectively reduce lung injury and improve clinical outcomes compared to HFNO.
Who should consider this trial
Good fit: Ideal candidates for this study are non-intubated patients aged 18 to 80 with ARDS and specific oxygenation criteria.
Not a fit: Patients with chronic respiratory failure, significant nasal obstruction, or those who have received invasive ventilation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into more effective non-invasive respiratory support options for ARDS patients, potentially reducing the need for intubation.
How similar studies have performed: Previous studies have shown that CPAP may be effective in reducing patient self-inflicted lung injury compared to HFNO, but this specific comparison in ARDS patients is still under investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * PaO2/FiO2 ratio \<300 mmHg with FiO2 \>40% and PEEP ≥5 cmH2O (CPAP) or flow ≥30 L/min (HFNC). * Bilateral pulmonary opacities observed in the chest X-ray, thoracic computerized tomography (CT) scan or lung ultrasonography (bilateral B lines) * \<7 days from the pulmonary insult to symptom onset and criteria 1 and 2 * Not meeting the aforementioned criteria for \>24 hours prior to study inclusion. Exclusion Criteria: * Age \<18 years or \>80 years * History of chronic respiratory failure or interstitial pulmonary disease * Acute cardiogenic pulmonary edema after echocardiographic evaluation * Having received either invasive mechanical ventilation or non-invasive mechanical ventilation (NIV) * Atelectasis, pleural effusion, pulmonary masses or nodules as the primary finding in thoracic imaging. * "Do not intubate, do not resuscitate" orders * Presenting significant nasal obstruction.
Where this trial is running
Barcelona, Barcelona
- Hospital Clínic de Barcelona — Barcelona, Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Ricard Mellado Artigas, PhD
- Email: rmellado@clinic.cat
- Phone: +34 646217716
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.