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NCT Number: NCT03758508

Non-invasive Ventilation Versus High Flow Oxygen

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ASST Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

Location status: Recruiting

Location contact

Andrea Bellone, MD

CONTACT

[email protected]

0039026444 ext. 7438

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High flow oxygen nasal cannula

Device

High Flow Oxygen nasal cannula

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

Primary outcomes

  1. PaO2/FiO2 improvement

    Time frame: at baseline and at 21 hours

    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

Secondary outcomes

  1. Intensive Care admission

    Time frame: 30 days

    Rate of admission to Intensive Care Unit in the two arms

  2. Sensation of device comfort and dyspnoea

    Time frame: Baseline, at 21 hours, 45 hours and 30 days after beginning treatment. Optional measures can be taken at 1, 3 and 9 hours

    Evaluation of subjective sensation of device comfort and dyspnoea in the two arms

  3. Time to downgrade to conventional oxygen therapy

    Time frame: 30 days

    Total amount of hours in which the patient needs to be treated with noninvasive ventilation alternate to versus high flow oxygen through nasal cannula

  4. In-hospital mortality

    Time frame: 30 days

    Mortality rate in the 2 arms

  5. New hospital admission

    Time frame: 30 days

    Rate of a new hospital admission within 30 days

  6. PaO2/FiO2 improvement

    Time frame: at baseline and at 45 hours

    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

  7. PaO2/FiO2 improvement

    Time frame: at baseline and at 30 days

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Bellone, MD

CONTACT

[email protected]

00396444 ext. 2495

Sponsors and collaborators

Lead sponsor

Niguarda Hospital

Other

Registry information

Official study title

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

Acronym: HFO

Important dates

Study start
2017
Primary completion
2019
Study completion
2027
First posted
Nov 29, 2018
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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