Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06694311

Effects of Continuous Positive Airway Pressure Versus High Flow Nasal Oxygenation for Acute Respiratory Distress Syndrome A Randomized Clinical Trial Comparing Two Non-invasive Respiratory Support Methods

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

Acute Respiratory Distress Syndrome (ARDS) causes breathing difficulties due to fluid buildup in the lungs not related to heart disease. Some affected patients may require invasive mechanical ventilation, but milder cases can receive extra oxygen through non-invasive devices like CPAP (continuous positive airway pressure) or HFNO (high flow nasal oxygenation). This trial examines whether CPAP, which may reduce lung injury caused by patients' own breathing efforts (P-SILI), actually leads to less lung damage compared to HFNO in real patients with ARDS. In this multicenter, randomized trial, 120 non-intubated ARDS patients will be assigned to receive either CPAP at 12 cmH2O or HFNO at 50 L/min for 48 hours along with standard intensive care. CPAP uses a nasal or facial mask to deliver oxygen at high pressure, while HFNO provides oxygen through nasal cannulas at high flow. Therapy breaks and adjustments after 48 hours are allowed based on clinical judgment, but non-invasive ventilation is not permitted during the study period. Participants will be monitored through blood tests measuring lung injury biomarkers such as sRAGE, angiotensin-II, interleukin-6, and interleukin-10, along with respiratory mechanics related to P-SILI. Researchers will also track rates of tracheal intubation at 48 hours and 90 days, as well as 90-day mortality. The study aims to improve understanding and treatment of ARDS in patients breathing spontaneously, potentially reducing the need for invasive ventilation and improving outcomes.

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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.

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Trial Site Locations

Total: 1 location

1

Hospital Clínic de Barcelona

Barcelona, Barcelona, Spain, 08036

Actively Recruiting

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Research Team

R

Ricard Mellado Artigas, PhD

J

Jordi Vallverdú Martínez, MD

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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Published Research Related To This Trial

Physiologic effects of two non-invasive respiratory support therapies (continuous positive airway pressure versus high-flow nasal oxygenation) in patients with acute respiratory distress syndrome: study protocol for a randomized clinical trial.

Jordi Vallverdú, Enric Barbeta, Ricard Mellado...

https://pubmed.ncbi.nlm.nih.gov/41484920