HFO: Non-invasive Ventilation Versus High Flow Oxygen

Sponsor

Niguarda Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03758508

Collaborator

(none)

128

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pneumonia-associated Acute Hypoxemic Respiratory Failure	Device: High Flow Oxygen nasal cannula Device: Noninvasive ventilation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

128 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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/FiO2Efficacy 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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2017

Actual Primary Completion Date :

Nov 1, 2019

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: HFO Continuous high flow oxygen through nasal cannula for 45 hours; longer if the clinical need persists	Device: High Flow Oxygen nasal cannula High Flow Oxygen nasal cannula
Active Comparator: NIV/HFO Alternating noninvasive ventilation (3 hours) and high flow oxygen through nasal cannula (3 hours) for 45 hours; longer if the clinical need persists	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

Arm

Intervention/Treatment

Active Comparator: HFO

Continuous high flow oxygen through nasal cannula for 45 hours; longer if the clinical need persists

Device: High Flow Oxygen nasal cannula

High Flow Oxygen nasal cannula

Active Comparator: NIV/HFO

Alternating noninvasive ventilation (3 hours) and high flow oxygen through nasal cannula (3 hours) for 45 hours; longer if the clinical need persists

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

Outcome Measures

Primary Outcome Measures

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

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
New hospital admission [30 days]
Rate of a new hospital admission within 30 days
PaO2/FiO2 improvement [at baseline and at 45 hours]
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ASST Grande Ospedale Metropolitano Niguarda	Milano		Italy	20162

Sponsors and Collaborators

Niguarda Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Niguarda Hospital

ClinicalTrials.gov Identifier:

NCT03758508

Other Study ID Numbers:

03-022018

First Posted:

Nov 29, 2018

Last Update Posted:

Jan 25, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Niguarda Hospital

Noninvasive ventilation

High flow oxygen nasal cannula

Pneumonia

Acute hypoxemic respiratory failure

Additional relevant MeSH terms:

Pneumonia

Respiratory Insufficiency

Study Results

No Results Posted as of Jan 25, 2022