Effect of Noninvasive Ventilation in Thoracic-abdominal Kinematics of Individuals With Heart Failure Associated With Cardiomegaly: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Thoraco-abdominal kinematics
研究概览
简要总结
Introduction: Noninvasive ventilation (NIV) has been used to minimize such impairment and increasing ventilator reserve in individuals with heart failure. Aim: To analyze thoracoabdominal kinematics (TK) in individuals with HF associated to cardiomegaly after using NIV. Methods: A randomized crossover clinical trial with allocation consisted of two experimental phases: NIV and control, 7 days apart of each other. During NIV phase, 30 minutes of bi-level ventilation was performed. Any type of ventilator support was offered during control phase. Optoeletronic plethismography was performed to asses TK.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •body mass index (BMI) <30 kg/m2
- •functional class II-III according to the New York Heart Association
- •of the echocardiogram últiimos 6 months showing ejection fraction (LVEF) ≤ 45%,
- •últiimos echocardiogram of six months showing cardiac hypertrophy (left Ventricular Diastolic Diameter (LVDD)> 55mm, Diameter Systolic left Ventricular (LVSD)> 45mm ),
- •(optimized from the point of view of drug,
- •clinical stability.
排除标准
- •unstable angina, myocardial infarction or heart surgery three months before the beginning of the research,
- •chronic orthopedic, infectious or metabolic diseases,
- •FEV1/FVC <70% predicted characterizing obstructive respiratory disorder;
- •active smokers;
- •Limitation on the use of NIV: claustrophobia, inability to remain with their mouths closed, abdominal distention, hemodynamic instability, heart rate (HR) <60 bpm, recent trauma, nausea and vomiting face.
结局指标
主要结局
Thoraco-abdominal kinematics
时间窗: Seven days
The thoraco-abdominal kinematics was performed by optoelectronic plethysmography which were evaluated as primary outcomes: volume change of rib cage (Δv CT), variables related to volume change of rib cage by hemithorax (ΔV ht CT): tidal volume of cash left thoracic (CT VC sx) and tidal volume right ribcage (VC CT dx); variables with distribution volume in different compartments: tidal volume on pulmonary rib cage (VC CTP), tidal volume in abdominal rib cage (VC CTA ) and tidal volume in the abdomen (AB VC).
次要结局
- Other ventilatory responses(Seven days)
研究者
Daniella Cunha Brandao
PhD
Universidade Federal de Pernambuco