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Non-invasive Ventilation Versus High Flow Oxygen

ConditionPneumonia-associated Acute Hypoxemic Respiratory Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNiguarda Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: HFOActive comparator 1 intervention
Group B: NIV/HFOActive comparator 2 interventions

Trial outcomes

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

Time frame
at baseline and at 21 hours

Secondary outcomes

1

Intensive Care admission

Rate of admission to Intensive Care Unit in the two arms

Time frame
30 days
2

Sensation of device comfort and dyspnoea

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

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
3

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

Time frame
30 days
4

In-hospital mortality

Mortality rate in the 2 arms

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Niguarda Hospital

Lead sponsor

Source ClinicalTrials.gov
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