Non-invasive Ventilation Versus High Flow Oxygen

NCT03758508 | Recruiting

• 1 other identifier: 03-022018
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pneumonia-associated Acute Hypoxemic Respiratory Failure

Keywords

Noninvasive ventilation; High flow oxygen nasal cannula; Pneumonia; Acute hypoxemic respiratory failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Intensive Care admission

  30 days

• Sensation of device comfort and dyspnoea

  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

  30 days

• In-hospital mortality

  30 days

• New hospital admission

  30 days

Study Arms (2)

HFO

ACTIVE COMPARATOR

Continuous high flow oxygen through nasal cannula for 45 hours; longer if the clinical need persists

Device: High Flow Oxygen nasal cannula

NIV/HFO

ACTIVE COMPARATOR

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; Device: Noninvasive ventilation

Interventions

High Flow Oxygen nasal cannula DEVICE

High Flow Oxygen nasal cannula

HFO; NIV/HFO

Noninvasive ventilation DEVICE

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

NIV/HFO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• 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

You may not qualify 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)
• 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

Sponsors & Collaborators

• Niguarda Hospital: lead

Study Sites (1)

ASST Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

RECRUITING

MeSH Terms

Conditions

Pneumonia; Respiratory Insufficiency

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Central Study Contacts

Andrea Bellone, MD

CONTACT

00396444; andrea.bellone@ospedaleniguarda.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 23, 2018
• First Posted: November 29, 2018
• Study Start: November 1, 2017
• Primary Completion: November 1, 2019
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

IT (1)