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Recruiting NCT05989139

HF vs NIV in Acute Cardiogenic Pulmonary Edema

No phase Interventional Pulmonary Edema Cardiac Cause

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NPPV/HFNC, HFNC/NPPV.
Who it may be relevant to
Registry conditions: Pulmonary Edema Cardiac Cause. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Interventions

  • 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 persis
  • 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 minute

Primary outcome measures

  • RV systolic function: Tricuspid annular plane systolic excursion (TAPSE), mm [Time frame: T0 (Patient's enrollment time)]
  • RV systolic function: Tricuspid annular plane systolic excursion (TAPSE), mm [Time frame: T1 (40 minutes after the first intervention has started)]
  • RV systolic function: Tricuspid annular plane systolic excursion (TAPSE), mm [Time frame: T2 (40 minutes after the second intervention has started)]
  • RV systolic function: RV fractional area change (RVFAC), % [Time frame: T0 (Patient's enrollment time)]
  • RV systolic function: RV fractional area change (RVFAC), % [Time frame: T1 (40 minutes after the first intervention has started)]
  • RV systolic function: RV fractional area change (RVFAC), % [Time frame: T2 (40 minutes after the second intervention has started)]
  • RV systolic function: RV Global Longitudinal strain (GLS), % [Time frame: T0 (Patient's enrollment time)]
  • RV systolic function: RV Global Longitudinal strain (GLS), % [Time frame: T1 (40 minutes after the first intervention has started)]
  • RV systolic function: RV Global Longitudinal strain (GLS), % [Time frame: T2 (40 minutes after the second intervention has started)]
Secondary outcome measures (12)
  • LV systolic function: Left Ventricle Ejection Fraction (LV EF), % [Time frame: T0 (Patient's enrollment time)]
  • LV systolic function: Left Ventricle Ejection Fraction (LV EF), % [Time frame: T1 (40 minutes after the first intervention has started)]
  • LV systolic function: Left Ventricle Ejection Fraction (LV EF), % [Time frame: T2 (40 minutes after the second intervention has started)]
  • LV diastolic function parameter, i.e. LV average E/E' ratio [Time frame: T0 (Patient's enrollment time)]
  • LV diastolic function parameter, i.e. LV average E/E' ratio [Time frame: T1 (40 minutes after the first intervention has started)]
  • LV diastolic function parameter, i.e. LV average E/E' ratio [Time frame: T2 (40 minutes after the second intervention has started)]
  • Inferior vena cava respiratory variations [Time frame: T0 (Patient's enrollment time)]
  • Inferior vena cava respiratory variations [Time frame: T1 (40 minutes after the first intervention has started)]
  • Inferior vena cava respiratory variations [Time frame: T2 (40 minutes after the second intervention has started)]
  • Physiological parameter: mean arterial pressure (MAP), mmHg [Time frame: T0 (Patient's enrollment time)]
  • Physiological parameter: mean arterial pressure (MAP), mmHg [Time frame: T1 (40 minutes after the first intervention has started)]
  • Physiological parameter: mean arterial pressure (MAP), mmHg [Time frame: T2 (40 minutes after the second intervention has started)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Fondazione IRCCS Policlinico Agostino Gemelli Roma — Roma

Identifiers

NCT: NCT05989139 · 5615

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗