Non-Invasive Ventilation And Right Ventricle Function In Cardiogenic Pulmonary Edema: An Echocardiographic Perspective To Select The Appropriate Ventilatory Support
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- RV systolic function: RV fractional area change (RVFAC), %
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
NPPV
non-invasive positive-pressure ventilation arm
Intervention: NPPV/HFNC (Procedure)
HFNC
High-flow nasal cannulae arm
Intervention: HFNC/NPPV (Procedure)
Outcomes
Primary Outcomes
RV systolic function: RV fractional area change (RVFAC), %
Time Frame: 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
Time Frame: 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), %
Time Frame: 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 Outcomes
- Physiological parameter: oxygen saturation (SpO2), %(T2 (40 minutes after the second intervention has started))
- LV diastolic function parameter, i.e. LV average E/E' ratio(T2 (40 minutes after the second intervention has started))
- LV systolic function: Left Ventricle Ejection Fraction (LV EF), %(T2 (40 minutes after the second intervention has started))
- Inferior vena cava respiratory variations(T2 (40 minutes after the second intervention has started))
- Physiological parameter: mean arterial pressure (MAP), mmHg(T2 (40 minutes after the second intervention has started))
Investigators
Sanna Tommaso
Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS