RecruitingNot ApplicableNCT06694311

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

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.

Sponsor

Ricard Mellado Artigas

Enrollment

120 participants

Start Date

Jan 7, 2025

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

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 Criteria7

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.

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Interventions

DEVICECPAP

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.

DEVICEHFNO 50 L/min

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.