Physiologic Effects of Continuous Positive Airway Pressure and High Flow Nasal Oxygenation in Patients with Acute Respiratory Distress Syndrome.

NCT06694311 | Recruiting DMC

• 1 other identifier: HCB/2023/1105
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Acute Respiratory Distress Syndrome (ARDS); Acute Respiratory Failure with Hypoxia

Keywords

Acute respiratory distress syndrome (ARDS); Continuous positive airway pressure (CPAP); High flow nasal oxygenation; Patient self-inflicted lung injury (P-SILI); Soluble receptor of advanced glycation end-products (sRAGE); Transpulmonary pressure

Outcome Measures

Primary Outcomes (1)

• sRAGE

  The primary outcome of this project is sRAGE, a plasma biomarker indicative of pulmonary epithelial dysfunction. This comparator was selected due to its established association with ventilator-induced lung injury (VILI) and mortality in intubated ARDS patients. sRAGE has got an excellent capacity to detect driving pressure \>14 cmH2O in ARDS patients undergoing invasive mechanical ventilation. This suggests that sRAGE may be an adequate biomarker for detecting pulmonary strain in non-intubated ARDS patients.

  From enrollment to the end of treatment at 48 hours.

Secondary Outcomes (5)

• Angiotensin-II

  From enrollment to the end of treatment at 48 hours.

• Interleukin 6

  From enrollment to the end of treatment at 48 hours.

• Interleukin 10

  From enrollment to the end of treatment at 48 hours.

• Orotraqueal intubation

  From enrollment to the end of treatment at 48 hours and at 90 days

• Mortality

  From enrollment to 90 days

Study Arms (2)

CPAP

EXPERIMENTAL

CPAP 12 cmH2O

Device: CPAP

HFNO

ACTIVE COMPARATOR

HFNO 50 L/min.

Device: HFNO 50 L/min

Interventions

CPAP DEVICE

12 cmH2O for 48 hours (at least 10 hours of therapy per day). Nasobucal interface will be the preferred route with complete facial mask being also an acceptable device. If needed, therapy breaks will be delivered with HFNO at 50 L/min. Non-invasive ventilation will not be allowed. After 48 hours of treatment, clinicians will be able to decide the respiratory support to be provided although CPAP will be recommended to be continued as long as PaO2/FiO2 is less than or equal to 300 and inspired oxygen fraction is 40% or more.

CPAP

HFNO 50 L/min DEVICE

HFNO 50 L/min for 48 hours. Therapy breaks with oxygen facemask will be allowed as per clinician decision but the protocol will advise against this practice. Non-invasive ventilation will not be allowed. After 48 hours of treatment, clinicians will be able to decide the respiratory support to be provided although HFNO will be recommended to be continued as long as PaO2/FiO2 is less than or equal to 300 and inspired oxygen fraction is 40% or more.

HFNO

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ricard Mellado Artigas: lead
• Hospital Clinic of Barcelona: collaborator
• Spanish Society of Pneumology and Thoracic Surgery: collaborator

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, Barcelona, 08036, Spain

RECRUITING

Related Publications (1)

• Vallverdu J, Barbeta E, Mellado R, Torres A, Ferrando C. 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. Trials. 2026 Jan 2. doi: 10.1186/s13063-025-09344-1. Online ahead of print.

  PMID: 41484920 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Carlos M Ferrando Ortolá, PhD

  Hospital Clinic of Barcelona

  STUDY DIRECTOR

Central Study Contacts

Ricard Mellado Artigas, PhD

CONTACT

+34 646217716; rmellado@clinic.cat

Jordi Vallverdú Martínez, MD

CONTACT

+34 622929752; vallverdu@clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Specialist, PhD

Model Details: This is a multicentric, randomized, open label, controlled, superiority clinical trial. Participants will undergo permuted block randomization with a ratio 1:1.

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start: January 7, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

ES (1)