Actively Recruiting
Physiologic Effects of Continuous Positive Airway Pressure and High Flow Nasal Oxygenation in Patients with Acute Respiratory Distress Syndrome.
Led by Ricard Mellado Artigas · Updated on 2025-01-15
120
Participants Needed
1
Research Sites
133 weeks
Total Duration
On this page
Sponsors
R
Ricard Mellado Artigas
Lead Sponsor
H
Hospital Clinic of Barcelona
Collaborating Sponsor
AI-Summary
What this Trial Is About
The acute respiratory distress syndrome (ARDS) consists on a lack of breath due to fluid overload in the lungs that is not produced by a heart desease. Some people with this condition may need to be intubated and connected to invasive mechanical ventilation, but less severe cases may need supplementary oxygen that can be delivered with non-invasive devices, such as CPAP (continuous positive airway pressure) or HFNO (high flow nasal oxygenation). CPAP consists on a facemask that provides oxygen-enriched air at a high pressure, whereas HFNO consists on nasal cannula that provides oxygen-enriched air at a high flow. Patients with ARDS may present with high respiratory efforts that can eventually damage their own lungs and contribute to the development of a phenomenon known as patient self-inflicted lung injury (P-SILI). Previous research has identified that CPAP may be successful in attuenuating P-SILI compared to HFNO, but it is not known whether this attenuation actually results into a reduction in lung injury in real patients. In this multicentre trial, 120 non-intubated patients with stablished ARDS will be randomly assigned to receive oxygen-enriched air through either CPAP or HFNO for 48 hours plus standard intensive care. The primary goal of this study is to determine the pulmonary effect of CPAP and HFNO through lung injury biomarkers that can be detected in blood, such as sRAGE (soluble Receptor of Advanced Glycation End-products), angiotensin-II, interleukin-6 and interleukin-10. It will also be studied whether CPAP reduces 48-hour traqueal intubation rate, 90-day traqueal intubation rate and 90-day mortality. Identifying that CPAP attenuates lung injury in spontaneously breathing ARDS patients will help clinicians to better understand this condition and to better treat this patients, so they do not evenutally need traqueal intubation and connection to invasive mechanical ventilation.
CONDITIONS
Official Title
Physiologic Effects of Continuous Positive Airway Pressure and High Flow Nasal Oxygenation in Patients with Acute Respiratory Distress Syndrome.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- PaO2/FiO2 ratio less than 300 mmHg with FiO2 greater than 40% and PEEP at least 5 cmH2O (for CPAP) or flow at least 30 L/min (for HFNO).
- Bilateral lung opacities seen on chest X-ray, CT scan, or lung ultrasound.
- Symptoms and lung findings started within 7 days of a lung injury.
- Not meeting the above criteria for more than 24 hours before study entry.
You will not qualify if you...
- Younger than 18 years or older than 80 years.
- History of chronic respiratory failure or interstitial lung disease.
- Acute heart-related lung swelling confirmed by echocardiogram.
- Previous use of invasive or non-invasive mechanical ventilation.
- Lung collapse, pleural effusion, tumors, or nodules as the main lung findings on imaging.
- Do not intubate or do not resuscitate orders.
- Significant nasal obstruction.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Clínic de Barcelona
Barcelona, Barcelona, Spain, 08036
Actively Recruiting
Research Team
R
Ricard Mellado Artigas, PhD
CONTACT
J
Jordi Vallverdú Martínez, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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