Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HFO | Active Comparator | Continuous high flow oxygen through nasal cannula for 45 hours; longer if the clinical need persists |
|
| NIV/HFO | Active Comparator | Alternating noninvasive ventilation (3 hours) and high flow oxygen through nasal cannula (3 hours) for 45 hours; longer if the clinical need persists |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Flow Oxygen nasal cannula | Device | High Flow Oxygen nasal cannula |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at baseline and at 21 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Intensive Care admission | Rate of admission to Intensive Care Unit in the two arms | 30 days |
| Sensation of device comfort and dyspnoea | Evaluation of subjective sensation of device comfort and dyspnoea in the two arms |
Not provided
Inclusion Criteria:
Diagnosis of pneumonia based on at least two clinical/laboratory criteria and 1 radiologic criterion among the following:
Hypoxemic respiratory failure, based on all the following criteria
Informed consent to study participation
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Bellone, MD | Contact | 00396444 | 2495 | andrea.bellone@ospedaleniguarda.it |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASST Grande Ospedale Metropolitano Niguarda | Recruiting | Milan | 20162 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
| 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 |
|
| 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 | Total amount of hours in which the patient needs to be treated with noninvasive ventilation alternate to versus high flow oxygen through nasal cannula | 30 days |
| In-hospital mortality | Mortality rate in the 2 arms | 30 days |
| New hospital admission | Rate of a new hospital admission within 30 days | 30 days |
| PaO2/FiO2 improvement | 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 | at baseline and at 45 hours |
| PaO2/FiO2 improvement | 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 | at baseline and at 30 days |
| D012120 |
| Respiration Disorders |