Non-Invasive Ventilation And Right Ventricle Function In Cardiogenic Pulmonary Edema: An Echocardiographic Perspective To Select The Appropriate Ventilatory Support
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- RV systolic function: RV fractional area change (RVFAC), %
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
NPPV
non-invasive positive-pressure ventilation arm
干预措施: NPPV/HFNC (Procedure)
HFNC
High-flow nasal cannulae arm
干预措施: HFNC/NPPV (Procedure)
结局指标
主要结局
RV systolic function: RV fractional area change (RVFAC), %
时间窗: 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
时间窗: 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), %
时间窗: 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 \[L0\] (%).
次要结局
- 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))
研究者
Sanna Tommaso
Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS