Clinical trial NCT03758508: Non-invasive Ventilation Versus High Flow Oxygen
Official title: Non-invasive Ventilation Versus High Flow Oxygen Through Nasal Cannula in Pneumonia Associated Acute Hypoxemic Respiratory Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pneumonia-associated Acute Hypoxemic Respiratory Failure
Keywords: Noninvasive ventilation
High flow oxygen nasal cannula
Pneumonia
Acute hypoxemic respiratory failure
Lead sponsor: Niguarda Hospital
Sponsor class: OTHER
First posted: 2018-11-29
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: PaO2/FiO2 improvement
timeFrame: at baseline and at 21 hours
Secondary outcomes:
measure: Intensive Care admission
timeFrame: 30 days
measure: Sensation of device comfort and dyspnoea
timeFrame: Baseline, at 21 hours, 45 hours and 30 days after beginning treatment. Optional measures can be taken at 1, 3 and 9 hours
measure: Time to downgrade to conventional oxygen therapy
timeFrame: 30 days
measure: In-hospital mortality
timeFrame: 30 days
measure: New hospital admission
timeFrame: 30 days
measure: PaO2/FiO2 improvement
timeFrame: at baseline and at 45 hours
measure: PaO2/FiO2 improvement
timeFrame: at baseline and at 30 days
Other outcomes:
Locations:
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
Study officials:
References: