Comparing Non-invasive Ventilation and High Flow Oxygen for Pneumonia-related Breathing Issues

Non-invasive Ventilation Versus High Flow Oxygen Through Nasal Cannula in Pneumonia Associated Acute Hypoxemic Respiratory Failure

This study is testing if using both Non-Invasive Ventilation and High Flow Oxygen together helps people with pneumonia-related breathing problems breathe better than just using High Flow Oxygen alone.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 128 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Niguarda Hospital (other)
• Locations: 1 site (Milan)
• Trial ID: NCT03758508 on ClinicalTrials.gov

What this trial studies

This study aims to compare the effectiveness of alternating Non-Invasive Ventilation (NIV) and High Flow Oxygen (HFO) against HFO alone in patients suffering from pneumonia-associated acute hypoxemic respiratory failure. It seeks to evaluate whether the combination of these two methods improves gas exchange and overall prognosis compared to using HFO by itself. Participants will be monitored for their respiratory function and clinical outcomes to determine the best approach for treatment in this specific patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are adults diagnosed with pneumonia who are experiencing acute hypoxemic respiratory failure.

Not a fit: Patients under 18 years old or those with hypercapnic respiratory failure or other causes of hypoxemic respiratory failure may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for patients with pneumonia-related respiratory failure, enhancing their recovery and quality of life.

How similar studies have performed: Previous studies have explored the use of NIV and HFO in respiratory failure, but this specific comparison in pneumonia cases is less established, making this approach somewhat novel.

Eligibility criteria

Inclusion 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

Exclusion Criteria:

* 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

Where this trial is running

Milan

• ASST Grande Ospedale Metropolitano Niguarda — Milan, Italy (RECRUITING)

Study contacts

• Study coordinator: Andrea Bellone, MD

Conditions: Pneumonia-associated Acute Hypoxemic Respiratory Failure, Noninvasive ventilation, High flow oxygen nasal cannula, Pneumonia, Acute hypoxemic respiratory failure