Non-invasive Ventilation Versus High Flow Oxygen (HFO)

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

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

Study Overview

• Status: Recruiting
• Conditions: Pneumonia-associated Acute Hypoxemic Respiratory Failure
• Intervention / Treatment: Device: High Flow Oxygen nasal cannula; Device: Noninvasive ventilation

Detailed Description

Both Non Invasive Ventilation (NIV) and High Flow Oxygen through nasal cannula (HFO) are widely used in the setting of hypoxemic respiratory failure of heterogeneous etiology, with no definitive evidence for the superiority of one technique on the other. The purpose of this study is to determine whether alternating NIV and HFO brings any advantage on gas exchanges and prognosis compared to the use of HFO alone in the homogeneous setting of pneumonia-associated acute hypoxemic respiratory failure

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Bellone, MD; Phone Number: 2495 00396444; Email: andrea.bellone@ospedaleniguarda.it

Study Locations

• Italy
  • Milan, Italy, 20162
    • Recruiting
    • Asst Grande Ospedale Metropolitano Niguarda
    • Contact: Andrea Bellone, MD; Phone Number: 7438 0039026444; Email: andrea.bellone@ospedaleniguarda.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HFO; Continuous high flow oxygen through nasal cannula for 45 hours; longer if the clinical need persists	Device: High Flow Oxygen nasal cannula; High Flow Oxygen nasal cannula
Active Comparator: 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	Device: High Flow Oxygen nasal cannula; High Flow Oxygen nasal cannula; Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PaO2/FiO2 improvement	Efficacy of alternating NIV and HFO compared to HFO alone in the determination of an improvement of PaO2/FiO2 at 21 hours compared to baseline PaO2/FiO2	at baseline and at 21 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensive Care admission	Rate of admission to Intensive Care Unit in the two arms	30 days
Sensation of device comfort and dyspnoea	Evaluation of subjective sensation of device comfort and dyspnoea in the two arms	Baseline, at 21 hours, 45 hours and 30 days after beginning treatment. Optional measures can be taken at 1, 3 and 9 hours
Time to downgrade to conventional oxygen therapy	Total amount of hours in which the patient needs to be treated with noninvasive ventilation alternate to versus high flow oxygen through nasal cannula	30 days
In-hospital mortality	Mortality rate in the 2 arms	30 days
New hospital admission	Rate of a new hospital admission within 30 days	30 days
PaO2/FiO2 improvement	Efficacy of alternating NIV and HFO compared to HFO alone in the determination of a change in PaO2/FiO2 at 45 hours compared to baseline PaO2/FiO2	at baseline and at 45 hours
PaO2/FiO2 improvement	Efficacy of alternating NIV and HFO compared to HFO alone in the determination of a change in PaO2/FiO2 at 30 hours compared to baseline PaO2/FiO2	at baseline and at 30 days

Collaborators and Investigators

• Sponsor: Niguarda Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): November 1, 2019
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 23, 2018
• First Submitted That Met QC Criteria: November 28, 2018
• First Posted (Actual): November 29, 2018

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pneumonia; Noninvasive ventilation; High flow oxygen nasal cannula; Acute hypoxemic respiratory failure
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Respiratory Insufficiency; Pneumonia; Therapeutics; Airway Management; Respiratory Therapy; Respiration, Artificial; Noninvasive Ventilation
• Other Study ID Numbers: 03-022018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No