HF vs NIV in Acute Cardiogenic Pulmonary Edema (HFvsNIV)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Pulmonary Edema Cardiac Cause
• Intervention / Treatment: Procedure: NPPV/HFNC; Procedure: HFNC/NPPV

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00168
    • Fondazione IRCCS Policlinico Agostino Gemelli Roma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NPPV; non-invasive positive-pressure ventilation arm	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.
Experimental: HFNC; High-flow nasal cannulae arm	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
LV systolic function: Left Ventricle Ejection Fraction (LV EF), %	Parameter of LV systolic function Normal value > 50%	T0 (Patient's enrollment time)
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)
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)
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)
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)
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)
Inferior vena cava respiratory variations	Echocardiographic parameter able to assess fluid responsiveness. Normal value >50%.	T0 (Patient's enrollment time)
Inferior vena cava respiratory variations	Echocardiographic parameter able to assess fluid responsiveness. Normal value >50%.	T1 (40 minutes after the first intervention has started)
Inferior vena cava respiratory variations	Echocardiographic parameter able to assess fluid responsiveness. Normal value >50%.	T2 (40 minutes after the second intervention has started)
Physiological parameter: mean arterial pressure (MAP), mmHg	Normal value >65 mmHg	T0 (Patient's enrollment time)
Physiological parameter: mean arterial pressure (MAP), mmHg	Normal value >65 mmHg	T1 (40 minutes after the first intervention has started)
Physiological parameter: mean arterial pressure (MAP), mmHg	Normal value >65 mmHg	T2 (40 minutes after the second intervention has started)
Physiological parameter: oxygen saturation (SpO2), %	Normal value > 90%	T0 (Patient's enrollment time)
Physiological parameter: oxygen saturation (SpO2), %	Normal value > 90%	T1 (40 minutes after the first intervention has started)
Physiological parameter: oxygen saturation (SpO2), %	Normal value > 90%	T2 (40 minutes after the second intervention has started)

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: June 22, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Edema; Pulmonary Edema
• Other Study ID Numbers: 5615

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No