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Recruiting NCT03758508

Non-invasive Ventilation Versus High Flow Oxygen

No phase Interventional Pneumonia-associated Acute Hypoxemic Respiratory Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High Flow Oxygen nasal cannula, Noninvasive ventilation.
Who it may be relevant to
Registry conditions: Pneumonia-associated Acute Hypoxemic Respiratory Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Interventions

  • 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

Primary outcome measures

  • PaO2/FiO2 improvement [Time frame: at baseline and at 21 hours]
Secondary outcome measures (7)
  • Intensive Care admission [Time frame: 30 days]
  • 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]
  • Time to downgrade to conventional oxygen therapy [Time frame: 30 days]
  • In-hospital mortality [Time frame: 30 days]
  • New hospital admission [Time frame: 30 days]
  • PaO2/FiO2 improvement [Time frame: at baseline and at 45 hours]
  • PaO2/FiO2 improvement [Time frame: at baseline and at 30 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • ASST Grande Ospedale Metropolitano Niguarda — Milan

Identifiers

NCT: NCT03758508 · 03-022018

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗