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Compares treatment options for Pneumonia-associated Acute Hypoxemic Respiratory Failure
Official title Non-invasive Ventilation Versus High Flow Oxygen
ClinicalTrials.gov ID: NCT03758508
What this study is testing
- What it's testing
- The purpose of the study is to compare the efficacy of alternating Non Invasive Ventilation NIV and High Flow Oxygen HFO compared to High Flow Oxygen HFO alone on gas exchanges and prognosis in pneumonia-associated acute hypoxemic respiratory failure
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of pneumonia based on at least two clinical/laboratory criteria and 1 radiologic criterion among the following:
- 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
You likely can't join if
- Age \< 18 years
- 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)
See the full eligibility criteria
- Diagnosis of pneumonia based on at least two clinical/laboratory criteria and 1 radiologic criterion among the following:
- 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
- Age \< 18 years
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Milan, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milan, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.