HF vs NIV in Acute Cardiogenic Pulmonary Edema

Not Applicable

Active, not recruiting

• Conditions: Pulmonary Edema Cardiac Cause
• Interventions: Procedure: HFNC/NPPV; Procedure: NPPV/HFNC

• Registration Number: NCT05989139
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-22
• Study First Submitted QC: 2023-08-02
• Study First Posted: 2023-08-14
• Study Start: 2024-01-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15
• Primary Completion: 2025-06-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HFNC	HFNC/NPPV	High-flow nasal cannulae arm
NPPV	NPPV/HFNC	non-invasive positive-pressure ventilation arm

Primary Outcome Measures

Name	Time	Method
RV systolic function: RV fractional area change (RVFAC), %	T2 (40 minutes after the second intervention has started)	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: Tricuspid annular plane systolic excursion (TAPSE), mm	T2 (40 minutes after the second intervention has started)	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 Global Longitudinal strain (GLS), %	T2 (40 minutes after the second intervention has started)	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

Name	Time	Method
LV diastolic function parameter, i.e. LV average E/E' ratio	T2 (40 minutes after the second intervention has started)	Parameter able to assess LV diastolic function. E/E' ratio normal value \< 12.
LV systolic function: Left Ventricle Ejection Fraction (LV EF), %	T2 (40 minutes after the second intervention has started)	Parameter of LV systolic function Normal value \> 50%
Inferior vena cava respiratory variations	T2 (40 minutes after the second intervention has started)	Echocardiographic parameter able to assess fluid responsiveness. Normal value \>50%.
Physiological parameter: oxygen saturation (SpO2), %	T2 (40 minutes after the second intervention has started)	Normal value \> 90%
Physiological parameter: mean arterial pressure (MAP), mmHg	T2 (40 minutes after the second intervention has started)	Normal value \>65 mmHg

Trial Locations

Locations (1)

Fondazione IRCCS Policlinico Agostino Gemelli Roma; 🇮🇹 Roma, Italy