Back to resultsHF vs NIV in Acute Cardiogenic Pulmonary Edema (HFvsNIV)
Primary Purpose
Pulmonary Edema Cardiac Cause
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NPPV/HFNC
HFNC/NPPV
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Edema Cardiac Cause
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 y.o.; Clinical diagnosis of ACPE in the setting of either AMI, acute myocarditis, acute/chronic severe mitral/aortic valve regurgitation, severe mitral/aortic stenosis, acute/chronic HF with rLVEF diagnosed according to European Society of Cardiology (ESC) guidelines [4]; Hypertensive crisis with systolic blood pressure >200 mmHg; Other congenital or acquired structural heart disease causing post capillary pulmonary hypertension or combination of the previous. Written informed consent. Exclusion Criteria: Age <18 y.o.; Hypercapnia with respiratory acidosis (PaCO2 > 45 mmHg with pH < 7.35); History of fever in the previous 4 days; White blood cell count > 12.000; Increased procalcitonin serum levels; Consolidative areas at chest radiograph; Hypotension (systolic blood pressure < 85 mmHg); Cardiogenic shock; Right ventricular (RV) dysfunction; Previous cardiac surgery, Glasgow Coma Scale score ≤ 8 points; Impaired ability to protect the airway from aspiration; Orotracheal intubation needed due to cardiopulmonary resuscitation maneuvers; Respiratory arrest; Severe hemodynamic instability; Facial trauma, burns, recent facial surgery or facial anatomy which prevents from the application of the NPPV interface to patient's face.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
NPPV
HFNC
Arm Description
non-invasive positive-pressure ventilation arm
High-flow nasal cannulae arm
Outcomes
Primary Outcome Measures
RV systolic function: Tricuspid annular plane systolic excursion (TAPSE), mm
Tricuspid annular plane systolic excursion (TAPSE) is a parameter of global RV function which describes apex-to-base shortening. Normal value > 16 mm.
RV systolic function: Tricuspid annular plane systolic excursion (TAPSE), mm
Tricuspid annular plane systolic excursion (TAPSE) is a parameter of global RV function which describes apex-to-base shortening. Normal value > 16 mm.
RV systolic function: Tricuspid annular plane systolic excursion (TAPSE), mm
Tricuspid annular plane systolic excursion (TAPSE) is a parameter of global RV function which describes apex-to-base shortening. Normal value > 16 mm.
RV systolic function: RV fractional area change (RVFAC), %
RV fractional area change (RVFAC) is a parameter of radial RV function. It is calculated, in apical four chambers view, as the difference between end-diastolic and end-systolic RV area divided by the end-diastolic area and multiplied by 100. Normal value > 35%.
RV systolic function: RV fractional area change (RVFAC), %
RV fractional area change (RVFAC) is a parameter of radial RV function. It is calculated, in apical four chambers view, as the difference between end-diastolic and end-systolic RV area divided by the end-diastolic area and multiplied by 100. Normal value > 35%.
RV systolic function: RV fractional area change (RVFAC), %
RV fractional area change (RVFAC) is a parameter of radial RV function. It is calculated, in apical four chambers view, as the difference between end-diastolic and end-systolic RV area divided by the end-diastolic area and multiplied by 100. Normal value > 35%.
RV systolic function: RV Global Longitudinal strain (GLS), %
RV Global Longitudinal strain (GLS) is an index of systolic performance of RV function. It evaluates the degree of myocardial deformation compared with its original length [L0] (%).
RV systolic function: RV Global Longitudinal strain (GLS), %
RV Global Longitudinal strain (GLS) is an index of systolic performance of RV function. It evaluates the degree of myocardial deformation compared with its original length [L0] (%).
RV systolic function: RV Global Longitudinal strain (GLS), %
RV Global Longitudinal strain (GLS) is an index of systolic performance of RV function. It evaluates the degree of myocardial deformation compared with its original length [L0] (%).
Secondary Outcome Measures
LV systolic function: Left Ventricle Ejection Fraction (LV EF), %
Parameter of LV systolic function Normal value > 50%
LV systolic function: Left Ventricle Ejection Fraction (LV EF), %
Parameter of LV systolic function Normal value > 50%
LV systolic function: Left Ventricle Ejection Fraction (LV EF), %
Parameter of LV systolic function Normal value > 50%
LV diastolic function parameter, i.e. LV average E/E' ratio
Parameter able to assess LV diastolic function. E/E' ratio normal value < 12.
LV diastolic function parameter, i.e. LV average E/E' ratio
Parameter able to assess LV diastolic function. E/E' ratio normal value < 12.
LV diastolic function parameter, i.e. LV average E/E' ratio
Parameter able to assess LV diastolic function. E/E' ratio normal value < 12.
Inferior vena cava respiratory variations
Echocardiographic parameter able to assess fluid responsiveness. Normal value >50%.
Inferior vena cava respiratory variations
Echocardiographic parameter able to assess fluid responsiveness. Normal value >50%.
Inferior vena cava respiratory variations
Echocardiographic parameter able to assess fluid responsiveness. Normal value >50%.
Physiological parameter: mean arterial pressure (MAP), mmHg
Normal value >65 mmHg
Physiological parameter: mean arterial pressure (MAP), mmHg
Normal value >65 mmHg
Physiological parameter: mean arterial pressure (MAP), mmHg
Normal value >65 mmHg
Physiological parameter: oxygen saturation (SpO2), %
Normal value > 90%
Physiological parameter: oxygen saturation (SpO2), %
Normal value > 90%
Physiological parameter: oxygen saturation (SpO2), %
Normal value > 90%
Full Information
NCT ID
NCT05989139
First Posted
June 22, 2023
Last Updated
August 18, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1. Study Identification
Unique Protocol Identification Number
NCT05989139
Brief Title
HF vs NIV in Acute Cardiogenic Pulmonary Edema
Acronym
HFvsNIV
Official Title
Non-Invasive Ventilation And Right Ventricle Function In Cardiogenic Pulmonary Edema: An Echocardiographic Perspective To Select The Appropriate Ventilatory Support
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study's primary aim is
to compare the effects of two different ventilation modalities, non-invasive positive-pressure ventilation (NPPV) and high-flow nasal cannulae (HFNC), in the acute cardiogenic pulmonary edema (ACPE) setting, in terms of echocardiographic parameters of RV systolic and RV strain.
to determine the differences of the two interventions on other hemodynamic parameters echocardiographically assessed.
to assess the differences between the two interventions on physiological parameters, i.e., mean arterial pressure (MAP), heart rate (HR), respiratory rate (RR), oxygen saturation (SpO2), and on arterial blood gases (ABG) analysis parameters (i.e. relief of dyspnea and respiratory distress, patient comfort).
Enrolled patients will receive NPPV and HFNC oxygen therapy in a randomized, cross-over fashion, for 40 minutes each (time 0, T0 and time 1, T1), followed by clinical and echocardiographic evaluation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Edema Cardiac Cause
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NPPV
Arm Type
Experimental
Arm Description
non-invasive positive-pressure ventilation arm
Arm Title
HFNC
Arm Type
Experimental
Arm Description
High-flow nasal cannulae arm
Intervention Type
Procedure
Intervention Name(s)
NPPV/HFNC
Intervention Description
Enrolled patients will receive NPPV and HFNC oxygen therapy in a randomized, cross-over fashion, for 40 minutes each. NPPV will be delivered through a full-face mask with a FiO2 starting at 100% and then titrated to achieve an SpO2 of 92-98%. Expiratory positive airway pressure (PEEP) will be firstly set to 5 cmH2O and then increased to a maximum of 15 cmH2O based on SpO2. Pressure support (PS) will be set to an initial value of 10 cmH2O and then increased if signs of respiratory distress persisted or worsened to a maximum value of 20 cmH2O. After 40 minutes, patient is shifted to HFNC ventilation support for 40 minutes.
At the end of the protocol, the patient will receive the treatment that will be shown as more appropriate for the patient, according to the attending physician, who will be informed about the results of the study on the individual patient.
Intervention Type
Procedure
Intervention Name(s)
HFNC/NPPV
Intervention Description
Enrolled patients will receive NPPV and HFNC oxygen therapy in a randomized, cross-over fashion, for 40 minutes each.
HFNC oxygen therapy will start at a flow rate of 60 L/min and will be gradually decreased by 5 cmH2O at time if the patient experienced discomfort. FiO2 will be started at 100% and then titrated to maintain a peripheral oxygen saturation of 92%-98%. Active heating and humidification were provided using MR850, Fisher and Paykel, with a temperature chamber of 37°C. After 40 minutes, patient is shifted to NPPV ventilation support for 40 minutes At the end of the protocol, the patient will receive the treatment that will be shown as more appropriate for the patient, according to the attending physician, who will be informed about the results of the study on the individual patient.
Primary Outcome Measure Information:
Title
RV systolic function: Tricuspid annular plane systolic excursion (TAPSE), mm
Description
Tricuspid annular plane systolic excursion (TAPSE) is a parameter of global RV function which describes apex-to-base shortening. Normal value > 16 mm.
Time Frame
T0 (Patient's enrollment time)
Title
RV systolic function: Tricuspid annular plane systolic excursion (TAPSE), mm
Description
Tricuspid annular plane systolic excursion (TAPSE) is a parameter of global RV function which describes apex-to-base shortening. Normal value > 16 mm.
Time Frame
T1 (40 minutes after the first intervention has started)
Title
RV systolic function: Tricuspid annular plane systolic excursion (TAPSE), mm
Description
Tricuspid annular plane systolic excursion (TAPSE) is a parameter of global RV function which describes apex-to-base shortening. Normal value > 16 mm.
Time Frame
T2 (40 minutes after the second intervention has started)
Title
RV systolic function: RV fractional area change (RVFAC), %
Description
RV fractional area change (RVFAC) is a parameter of radial RV function. It is calculated, in apical four chambers view, as the difference between end-diastolic and end-systolic RV area divided by the end-diastolic area and multiplied by 100. Normal value > 35%.
Time Frame
T0 (Patient's enrollment time)
Title
RV systolic function: RV fractional area change (RVFAC), %
Description
RV fractional area change (RVFAC) is a parameter of radial RV function. It is calculated, in apical four chambers view, as the difference between end-diastolic and end-systolic RV area divided by the end-diastolic area and multiplied by 100. Normal value > 35%.
Time Frame
T1 (40 minutes after the first intervention has started)
Title
RV systolic function: RV fractional area change (RVFAC), %
Description
RV fractional area change (RVFAC) is a parameter of radial RV function. It is calculated, in apical four chambers view, as the difference between end-diastolic and end-systolic RV area divided by the end-diastolic area and multiplied by 100. Normal value > 35%.
Time Frame
T2 (40 minutes after the second intervention has started)
Title
RV systolic function: RV Global Longitudinal strain (GLS), %
Description
RV Global Longitudinal strain (GLS) is an index of systolic performance of RV function. It evaluates the degree of myocardial deformation compared with its original length [L0] (%).
Time Frame
T0 (Patient's enrollment time)
Title
RV systolic function: RV Global Longitudinal strain (GLS), %
Description
RV Global Longitudinal strain (GLS) is an index of systolic performance of RV function. It evaluates the degree of myocardial deformation compared with its original length [L0] (%).
Time Frame
T1 (40 minutes after the first intervention has started)
Title
RV systolic function: RV Global Longitudinal strain (GLS), %
Description
RV Global Longitudinal strain (GLS) is an index of systolic performance of RV function. It evaluates the degree of myocardial deformation compared with its original length [L0] (%).
Time Frame
T2 (40 minutes after the second intervention has started)
Secondary Outcome Measure Information:
Title
LV systolic function: Left Ventricle Ejection Fraction (LV EF), %
Description
Parameter of LV systolic function Normal value > 50%
Time Frame
T0 (Patient's enrollment time)
Title
LV systolic function: Left Ventricle Ejection Fraction (LV EF), %
Description
Parameter of LV systolic function Normal value > 50%
Time Frame
T1 (40 minutes after the first intervention has started)
Title
LV systolic function: Left Ventricle Ejection Fraction (LV EF), %
Description
Parameter of LV systolic function Normal value > 50%
Time Frame
T2 (40 minutes after the second intervention has started)
Title
LV diastolic function parameter, i.e. LV average E/E' ratio
Description
Parameter able to assess LV diastolic function. E/E' ratio normal value < 12.
Time Frame
T0 (Patient's enrollment time)
Title
LV diastolic function parameter, i.e. LV average E/E' ratio
Description
Parameter able to assess LV diastolic function. E/E' ratio normal value < 12.
Time Frame
T1 (40 minutes after the first intervention has started)
Title
LV diastolic function parameter, i.e. LV average E/E' ratio
Description
Parameter able to assess LV diastolic function. E/E' ratio normal value < 12.
Time Frame
T2 (40 minutes after the second intervention has started)
Title
Inferior vena cava respiratory variations
Description
Echocardiographic parameter able to assess fluid responsiveness. Normal value >50%.
Time Frame
T0 (Patient's enrollment time)
Title
Inferior vena cava respiratory variations
Description
Echocardiographic parameter able to assess fluid responsiveness. Normal value >50%.
Time Frame
T1 (40 minutes after the first intervention has started)
Title
Inferior vena cava respiratory variations
Description
Echocardiographic parameter able to assess fluid responsiveness. Normal value >50%.
Time Frame
T2 (40 minutes after the second intervention has started)
Title
Physiological parameter: mean arterial pressure (MAP), mmHg
Description
Normal value >65 mmHg
Time Frame
T0 (Patient's enrollment time)
Title
Physiological parameter: mean arterial pressure (MAP), mmHg
Description
Normal value >65 mmHg
Time Frame
T1 (40 minutes after the first intervention has started)
Title
Physiological parameter: mean arterial pressure (MAP), mmHg
Description
Normal value >65 mmHg
Time Frame
T2 (40 minutes after the second intervention has started)
Title
Physiological parameter: oxygen saturation (SpO2), %
Description
Normal value > 90%
Time Frame
T0 (Patient's enrollment time)
Title
Physiological parameter: oxygen saturation (SpO2), %
Description
Normal value > 90%
Time Frame
T1 (40 minutes after the first intervention has started)
Title
Physiological parameter: oxygen saturation (SpO2), %
Description
Normal value > 90%
Time Frame
T2 (40 minutes after the second intervention has started)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 y.o.;
Clinical diagnosis of ACPE in the setting of either AMI, acute myocarditis, acute/chronic severe mitral/aortic valve regurgitation, severe mitral/aortic stenosis, acute/chronic HF with rLVEF diagnosed according to European Society of Cardiology (ESC) guidelines [4];
Hypertensive crisis with systolic blood pressure >200 mmHg;
Other congenital or acquired structural heart disease causing post capillary pulmonary hypertension or combination of the previous.
Written informed consent.
Exclusion Criteria:
Age <18 y.o.;
Hypercapnia with respiratory acidosis (PaCO2 > 45 mmHg with pH < 7.35);
History of fever in the previous 4 days;
White blood cell count > 12.000;
Increased procalcitonin serum levels;
Consolidative areas at chest radiograph;
Hypotension (systolic blood pressure < 85 mmHg);
Cardiogenic shock;
Right ventricular (RV) dysfunction;
Previous cardiac surgery,
Glasgow Coma Scale score ≤ 8 points;
Impaired ability to protect the airway from aspiration;
Orotracheal intubation needed due to cardiopulmonary resuscitation maneuvers;
Respiratory arrest;
Severe hemodynamic instability;
Facial trauma, burns, recent facial surgery or facial anatomy which prevents from the application of the NPPV interface to patient's face.
12. IPD Sharing Statement
Learn more about this trial
HF vs NIV in Acute Cardiogenic Pulmonary Edema
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