Non-invasive Ventilation Versus High Flow Oxygen

Not Applicable

Recruiting

• Conditions: Pneumonia-associated Acute Hypoxemic Respiratory Failure
• Interventions: Device: High Flow Oxygen nasal cannula; Device: Noninvasive ventilation

• Registration Number: NCT03758508
• Lead Sponsor: Niguarda Hospital

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

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 Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2018-11-23
• Study First Submitted QC: 2018-11-28
• Study First Posted: 2018-11-29
• Primary Completion: 2019-11-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-22
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NIV/HFO	Noninvasive ventilation	Alternating noninvasive ventilation (3 hours) and high flow oxygen through nasal cannula (3 hours) for 45 hours; longer if the clinical need persists
HFO	High Flow Oxygen nasal cannula	Continuous high flow oxygen through nasal cannula for 45 hours; longer if the clinical need persists
NIV/HFO	High Flow Oxygen nasal cannula	Alternating noninvasive ventilation (3 hours) and high flow oxygen through nasal cannula (3 hours) for 45 hours; longer if the clinical need persists

Primary Outcome Measures

Name	Time	Method
PaO2/FiO2 improvement	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 Outcome Measures

Name	Time	Method
New hospital admission	30 days	Rate of a new hospital admission within 30 days
PaO2/FiO2 improvement	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
Intensive Care admission	30 days	Rate of admission to Intensive Care Unit in the two arms
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	Evaluation of subjective sensation of device comfort and dyspnoea in the two arms
Time to downgrade to conventional oxygen therapy	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
In-hospital mortality	30 days	Mortality rate in the 2 arms

Trial Locations

Locations (1)

ASST Grande Ospedale Metropolitano Niguarda; 🇮🇹 Milano, Italy