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Non-invasive Ventilation Versus High Flow Oxygen (HFO)

Primary Purpose

Pneumonia-associated Acute Hypoxemic Respiratory Failure

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
High Flow Oxygen nasal cannula
Noninvasive ventilation
Sponsored by
Niguarda Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia-associated Acute Hypoxemic Respiratory Failure focused on measuring Noninvasive ventilation, High flow oxygen nasal cannula, Pneumonia, Acute hypoxemic respiratory failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • ASST Grande Ospedale Metropolitano NiguardaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

HFO

NIV/HFO

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Intensive Care admission
Rate of admission to Intensive Care Unit in the two arms
Sensation of device comfort and dyspnoea
Evaluation of subjective sensation of device comfort and dyspnoea in the two arms
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
In-hospital mortality
Mortality rate in the 2 arms
New hospital admission
Rate of a new hospital admission within 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
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

Full Information

First Posted
November 23, 2018
Last Updated
March 21, 2023
Sponsor
Niguarda Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03758508
Brief Title
Non-invasive Ventilation Versus High Flow Oxygen
Acronym
HFO
Official Title
Non-invasive Ventilation Versus High Flow Oxygen Through Nasal Cannula in Pneumonia Associated Acute Hypoxemic Respiratory Failure
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Niguarda Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia-associated Acute Hypoxemic Respiratory Failure
Keywords
Noninvasive ventilation, High flow oxygen nasal cannula, Pneumonia, Acute hypoxemic respiratory failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HFO
Arm Type
Active Comparator
Arm Description
Continuous high flow oxygen through nasal cannula for 45 hours; longer if the clinical need persists
Arm Title
NIV/HFO
Arm Type
Active Comparator
Arm Description
Alternating noninvasive ventilation (3 hours) and high flow oxygen through nasal cannula (3 hours) for 45 hours; longer if the clinical need persists
Intervention Type
Device
Intervention Name(s)
High Flow Oxygen nasal cannula
Intervention Description
High Flow Oxygen nasal cannula
Intervention Type
Device
Intervention Name(s)
Noninvasive ventilation
Intervention Description
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
Primary Outcome Measure Information:
Title
PaO2/FiO2 improvement
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
Time Frame
at baseline and at 21 hours
Secondary Outcome Measure Information:
Title
Intensive Care admission
Description
Rate of admission to Intensive Care Unit in the two arms
Time Frame
30 days
Title
Sensation of device comfort and dyspnoea
Description
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
Title
Time to downgrade to conventional oxygen therapy
Description
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
Title
In-hospital mortality
Description
Mortality rate in the 2 arms
Time Frame
30 days
Title
New hospital admission
Description
Rate of a new hospital admission within 30 days
Time Frame
30 days
Title
PaO2/FiO2 improvement
Description
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
Time Frame
at baseline and at 45 hours
Title
PaO2/FiO2 improvement
Description
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
Time Frame
at baseline and at 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Bellone, MD
Phone
00396444
Ext
2495
Email
andrea.bellone@ospedaleniguarda.it
Facility Information:
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Bellone, MD
Phone
0039026444
Ext
7438
Email
andrea.bellone@ospedaleniguarda.it

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Non-invasive Ventilation Versus High Flow Oxygen

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