HF vs NIV in Acute Cardiogenic Pulmonary Edema

Pulmonary Edema Cardiac Cause Clinical Trial

— HFvsNIV  

Official title:

Non-Invasive Ventilation And Right Ventricle Function In Cardiogenic Pulmonary Edema: An Echocardiographic Perspective To Select The Appropriate Ventilatory Support

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05989139
• Other study ID #: 5615
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: September 1, 2025

Study information

• Verified date: March 2024
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: September 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Edema
• Pulmonary Edema
• Pulmonary Edema Cardiac Cause

Intervention

Procedure:
• NPPV/HFNC
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.
• HFNC/NPPV
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.

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Policlinico Agostino Gemelli Roma	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	T0 (Patient's enrollment time)
Primary	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.	T1 (40 minutes after the first intervention has started)
Primary	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.	T2 (40 minutes after the second intervention has started)
Primary	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%.	T0 (Patient's enrollment time)
Primary	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%.	T1 (40 minutes after the first intervention has started)
Primary	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%.	T2 (40 minutes after the second intervention has started)
Primary	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] (%).	T0 (Patient's enrollment time)
Primary	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] (%).	T1 (40 minutes after the first intervention has started)
Primary	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] (%).	T2 (40 minutes after the second intervention has started)
Secondary	LV systolic function: Left Ventricle Ejection Fraction (LV EF), %	Parameter of LV systolic function Normal value > 50%	T0 (Patient's enrollment time)
Secondary	LV systolic function: Left Ventricle Ejection Fraction (LV EF), %	Parameter of LV systolic function Normal value > 50%	T1 (40 minutes after the first intervention has started)
Secondary	LV systolic function: Left Ventricle Ejection Fraction (LV EF), %	Parameter of LV systolic function Normal value > 50%	T2 (40 minutes after the second intervention has started)
Secondary	LV diastolic function parameter, i.e. LV average E/E' ratio	Parameter able to assess LV diastolic function. E/E' ratio normal value < 12.	T0 (Patient's enrollment time)
Secondary	LV diastolic function parameter, i.e. LV average E/E' ratio	Parameter able to assess LV diastolic function. E/E' ratio normal value < 12.	T1 (40 minutes after the first intervention has started)
Secondary	LV diastolic function parameter, i.e. LV average E/E' ratio	Parameter able to assess LV diastolic function. E/E' ratio normal value < 12.	T2 (40 minutes after the second intervention has started)
Secondary	Inferior vena cava respiratory variations	Echocardiographic parameter able to assess fluid responsiveness. Normal value >50%.	T0 (Patient's enrollment time)
Secondary	Inferior vena cava respiratory variations	Echocardiographic parameter able to assess fluid responsiveness. Normal value >50%.	T1 (40 minutes after the first intervention has started)
Secondary	Inferior vena cava respiratory variations	Echocardiographic parameter able to assess fluid responsiveness. Normal value >50%.	T2 (40 minutes after the second intervention has started)
Secondary	Physiological parameter: mean arterial pressure (MAP), mmHg	Normal value >65 mmHg	T0 (Patient's enrollment time)
Secondary	Physiological parameter: mean arterial pressure (MAP), mmHg	Normal value >65 mmHg	T1 (40 minutes after the first intervention has started)
Secondary	Physiological parameter: mean arterial pressure (MAP), mmHg	Normal value >65 mmHg	T2 (40 minutes after the second intervention has started)
Secondary	Physiological parameter: oxygen saturation (SpO2), %	Normal value > 90%	T0 (Patient's enrollment time)
Secondary	Physiological parameter: oxygen saturation (SpO2), %	Normal value > 90%	T1 (40 minutes after the first intervention has started)
Secondary	Physiological parameter: oxygen saturation (SpO2), %	Normal value > 90%	T2 (40 minutes after the second intervention has started)