Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
128 participants
INTERVENTIONAL
2017-11-01
2025-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HFO
Continuous high flow oxygen through nasal cannula for 45 hours; longer if the clinical need persists
High Flow Oxygen nasal cannula
High Flow Oxygen nasal cannula
NIV/HFO
Alternating noninvasive ventilation (3 hours) and high flow oxygen through nasal cannula (3 hours) for 45 hours; longer if the clinical need persists
High Flow Oxygen nasal cannula
High Flow Oxygen nasal cannula
Noninvasive ventilation
In this arm, participants receive noninvasive ventilation through an interface (such as full face mask or oro-nasal mask) alternated with continuous high flow oxygen though humidified nasal cannula
Interventions
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High Flow Oxygen nasal cannula
High Flow Oxygen nasal cannula
Noninvasive ventilation
In this arm, participants receive noninvasive ventilation through an interface (such as full face mask or oro-nasal mask) alternated with continuous high flow oxygen though humidified nasal cannula
Eligibility Criteria
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Inclusion Criteria
* Clinical criteria: fever, cough, purulent sputum, pulmonary examination positive for signs consistent with pneumonia
* Laboratory criteria: leukocytosis (White blood cells \>10000/mcL) or leukopenia (White blood cells \< 4000/mcL), rise of the inflammatory markers
* Radiologic criteria: consolidations at Chest X-ray or CT scan
* Hypoxemic respiratory failure, based on all the following criteria
* PaO2/FiO2 \< 300 after at least 15 minutes conventional oxygen therapy with a FiO2 ≥ 50%
* Respiratory Rate (RR) ≥ 25/min or need for use of accessory muscles
* Informed consent to study participation
Exclusion Criteria
* Hypercapnic respiratory failure (pCO2 \> 60 mmHg at presentation) such as in Chronic Obstructive Pulmonary Disease
* Presence of another cause of hypoxemic respiratory failure - e.g. pulmonary embolism, acute respiratory distress syndrome (ARDS), pulmonary oedema
* Hemodynamic instability with necessity for use of inotropes and/or vasopressors
* Indication for endotracheal intubation (ETI): Glasgow Coma Scale (GCS) \<8, agitation, device intolerance, respiratory arrest
* Immunosuppression (chronic immunosuppressive therapy, clinical history positive for any immunodeficiency - congenital or acquired)
* Do Not Resuscitate (DNR) and Do Not Intubate (DNI) indication
* Tracheostomy
* Nocturnal CPAP ventilation therapy
* Any other condition which the clinician would considered an adjunctive risk for taking part in the study or that would not permit the participant to complete it
18 Years
ALL
No
Sponsors
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Niguarda Hospital
OTHER
Responsible Party
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Locations
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ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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03-022018
Identifier Type: -
Identifier Source: org_study_id
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