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NCT Number: NCT05989139

HF vs NIV in Acute Cardiogenic Pulmonary Edema

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

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Key information

Conditions

Pulmonary Edema Cardiac Cause Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Policlinico Agostino Gemelli Roma

Roma, 00168, Italy

Location status: Recruiting

Location contact

Tommaso Sanna

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NPPV/HFNC

Procedure

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

Procedure

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.

Primary outcomes

  1. RV systolic function: Tricuspid annular plane systolic excursion (TAPSE), mm

    Time frame: T0 (Patient's enrollment time)

    Tricuspid annular plane systolic excursion (TAPSE) is a parameter of global RV function which describes apex-to-base shortening. Normal value > 16 mm.

  2. RV systolic function: Tricuspid annular plane systolic excursion (TAPSE), mm

    Time frame: T1 (40 minutes after the first 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.

  3. 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.

  4. RV systolic function: RV fractional area change (RVFAC), %

    Time frame: T0 (Patient's enrollment time)

    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%.

  5. RV systolic function: RV fractional area change (RVFAC), %

    Time frame: T1 (40 minutes after the first 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%.

  6. 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%.

  7. RV systolic function: RV Global Longitudinal strain (GLS), %

    Time frame: T0 (Patient's enrollment time)

    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] (%).

  8. RV systolic function: RV Global Longitudinal strain (GLS), %

    Time frame: T1 (40 minutes after the first 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] (%).

  9. 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

  1. LV systolic function: Left Ventricle Ejection Fraction (LV EF), %

    Time frame: T0 (Patient's enrollment time)

    Parameter of LV systolic function Normal value > 50%

  2. LV systolic function: Left Ventricle Ejection Fraction (LV EF), %

    Time frame: T1 (40 minutes after the first intervention has started)

    Parameter of LV systolic function Normal value > 50%

  3. LV systolic function: Left Ventricle Ejection Fraction (LV EF), %

    Time frame: T2 (40 minutes after the second intervention has started)

    Parameter of LV systolic function Normal value > 50%

  4. LV diastolic function parameter, i.e. LV average E/E' ratio

    Time frame: T0 (Patient's enrollment time)

    Parameter able to assess LV diastolic function. E/E' ratio normal value < 12.

  5. LV diastolic function parameter, i.e. LV average E/E' ratio

    Time frame: T1 (40 minutes after the first intervention has started)

    Parameter able to assess LV diastolic function. E/E' ratio normal value < 12.

  6. LV diastolic function parameter, i.e. LV average E/E' ratio

    Time frame: T2 (40 minutes after the second intervention has started)

    Parameter able to assess LV diastolic function. E/E' ratio normal value < 12.

  7. Inferior vena cava respiratory variations

    Time frame: T0 (Patient's enrollment time)

    Echocardiographic parameter able to assess fluid responsiveness. Normal value >50%.

  8. Inferior vena cava respiratory variations

    Time frame: T1 (40 minutes after the first intervention has started)

    Echocardiographic parameter able to assess fluid responsiveness. Normal value >50%.

  9. Inferior vena cava respiratory variations

    Time frame: T2 (40 minutes after the second intervention has started)

    Echocardiographic parameter able to assess fluid responsiveness. Normal value >50%.

  10. Physiological parameter: mean arterial pressure (MAP), mmHg

    Time frame: T0 (Patient's enrollment time)

    Normal value >65 mmHg

  11. Physiological parameter: mean arterial pressure (MAP), mmHg

    Time frame: T1 (40 minutes after the first intervention has started)

    Normal value >65 mmHg

  12. Physiological parameter: mean arterial pressure (MAP), mmHg

    Time frame: T2 (40 minutes after the second intervention has started)

    Normal value >65 mmHg

  13. Physiological parameter: oxygen saturation (SpO2), %

    Time frame: T0 (Patient's enrollment time)

    Normal value > 90%

  14. Physiological parameter: oxygen saturation (SpO2), %

    Time frame: T1 (40 minutes after the first intervention has started)

    Normal value > 90%

  15. Physiological parameter: oxygen saturation (SpO2), %

    Time frame: T2 (40 minutes after the second intervention has started)

    Normal value > 90%

Study contacts

Contact information is provided by the study sponsor or research team.

Tommaso Sanna

CONTACT

[email protected]

00390630154187

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: HFvsNIV

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 14, 2023
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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