Non-invasive Ventilation Versus High Flow Oxygen

Launched by NIGUARDA HOSPITAL · Nov 28, 2018

Keywords

ClinConnect Summary

This clinical trial is comparing two types of breathing support for patients with pneumonia-related breathing problems. Specifically, the study is looking at whether alternating between Non-Invasive Ventilation (NIV) and High Flow Oxygen (HFO) is more effective than using High Flow Oxygen alone. The goal is to see which method helps patients breathe better and improves their overall health during this serious condition.

To participate in this study, you need to be between 65 and 74 years old and have pneumonia confirmed by certain medical tests, along with breathing difficulties. You should not have other serious health issues that could complicate your treatment or recovery. If you join the trial, you will receive one of the two types of breathing support, and doctors will closely monitor your progress. It's important to know that this study is currently looking for participants, and your involvement could help improve treatment options for future patients with similar conditions.

Gender

ALL

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