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Идёт набор NCT05989139

HF vs NIV in Acute Cardiogenic Pulmonary Edema

Без фазы С лечением Pulmonary Edema Cardiac Cause

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: NPPV/HFNC, HFNC/NPPV.
Кому может быть актуально
Состояния в реестре: Pulmonary Edema Cardiac Cause. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
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Официальное название

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

Обзор

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

Вмешательства

  • Процедура 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
  • Процедура 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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Италия · 1 центр
  • Fondazione IRCCS Policlinico Agostino Gemelli Roma — Roma

Идентификаторы

NCT: NCT05989139 · 5615

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗