Clinical trial NCT05989139: HF vs NIV in Acute Cardiogenic Pulmonary Edema
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pulmonary Edema Cardiac Cause
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: RV systolic function: Tricuspid annular plane systolic excursion (TAPSE), mm
timeFrame: T0 (Patient's enrollment time)
measure: RV systolic function: Tricuspid annular plane systolic excursion (TAPSE), mm
timeFrame: T1 (40 minutes after the first intervention has started)
measure: RV systolic function: Tricuspid annular plane systolic excursion (TAPSE), mm
timeFrame: T2 (40 minutes after the second intervention has started)
measure: RV systolic function: RV fractional area change (RVFAC), %
timeFrame: T0 (Patient's enrollment time)
measure: RV systolic function: RV fractional area change (RVFAC), %
timeFrame: T1 (40 minutes after the first intervention has started)
measure: RV systolic function: RV fractional area change (RVFAC), %
timeFrame: T2 (40 minutes after the second intervention has started)
measure: RV systolic function: RV Global Longitudinal strain (GLS), %
timeFrame: T0 (Patient's enrollment time)
measure: RV systolic function: RV Global Longitudinal strain (GLS), %
timeFrame: T1 (40 minutes after the first intervention has started)
measure: RV systolic function: RV Global Longitudinal strain (GLS), %
timeFrame: T2 (40 minutes after the second intervention has started)
Secondary outcomes:
measure: LV systolic function: Left Ventricle Ejection Fraction (LV EF), %
timeFrame: T0 (Patient's enrollment time)
measure: LV systolic function: Left Ventricle Ejection Fraction (LV EF), %
timeFrame: T1 (40 minutes after the first intervention has started)
measure: LV systolic function: Left Ventricle Ejection Fraction (LV EF), %
timeFrame: T2 (40 minutes after the second intervention has started)
measure: LV diastolic function parameter, i.e. LV average E/E' ratio
timeFrame: T0 (Patient's enrollment time)
measure: LV diastolic function parameter, i.e. LV average E/E' ratio
timeFrame: T1 (40 minutes after the first intervention has started)
measure: LV diastolic function parameter, i.e. LV average E/E' ratio
timeFrame: T2 (40 minutes after the second intervention has started)
measure: Inferior vena cava respiratory variations
timeFrame: T0 (Patient's enrollment time)
measure: Inferior vena cava respiratory variations
timeFrame: T1 (40 minutes after the first intervention has started)
measure: Inferior vena cava respiratory variations
timeFrame: T2 (40 minutes after the second intervention has started)
measure: Physiological parameter: mean arterial pressure (MAP), mmHg
timeFrame: T0 (Patient's enrollment time)
measure: Physiological parameter: mean arterial pressure (MAP), mmHg
timeFrame: T1 (40 minutes after the first intervention has started)
measure: Physiological parameter: mean arterial pressure (MAP), mmHg
timeFrame: T2 (40 minutes after the second intervention has started)
measure: Physiological parameter: oxygen saturation (SpO2), %
timeFrame: T0 (Patient's enrollment time)
measure: Physiological parameter: oxygen saturation (SpO2), %
timeFrame: T1 (40 minutes after the first intervention has started)
measure: Physiological parameter: oxygen saturation (SpO2), %
timeFrame: T2 (40 minutes after the second intervention has started)
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione IRCCS Policlinico Agostino Gemelli Roma
Study officials:
References: