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临床试验/NCT02481388
NCT02481388Unknown不适用

Effect of Cardiomegaly Associated With Inspiratory Muscle Weakness on Diaphragm Thickness and Chest Wall Volume Distribution in Patients With Heart Failure

Universidade Federal de Pernambuco1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
14
试验地点
1
主要终点
Chest Wall tricompartmental volumes

研究概览

简要总结

The investigators aimed to evaluate the effects of cardiomegaly associated with inspiratory muscle weakness on tricompartmental distribution of chest wall volumes, on the thickness of the right hemidiaphragm and on the contraction speed of the respiratory muscles. As method of the present research, a pilot cross-sectional study was conducted with fourteen (14) patients with heart failure, functional class II and III, clinically stable, with cardiomegaly. Two groups were formed: one group with inspiratory muscle weakness (WG) (maximal inspiratory pressure - MIP <70% predicted MIP) and a control group without weakness (CG). The pulmonary and respiratory muscle functions were assessed by spirometry and manometer, respectively. Before and after maximal exercise test, optoelectronic plethysmography was performed to evaluate the distribution of volumes, the kinematics and the contraction speed of chest wall muscles. The high-resolution ultrasonography was also used before and after the maximum test for obtaining diaphragmatic thickness

研究设计

研究类型
Observational
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Both sexes, 18-60 years;
  • Functional Class II-III according to the New York Heart Association;
  • Echocardiography of the last six months showing showing left ventricular ejection fraction (LVEF) ≤ 45% measured by Teichholz method;
  • Echocardiography the last six months showing cardiac hypertrophy (Diameter of Left Ventricular Diastolic (LVDD)> 54 mm, diameter of Systolic Left Ventricular (LVSD)> 34mm) 30 measured by Teichholz method;
  • Optimized by the medical point of view and
  • Clinical stability

排除标准

  • Unstable angina; myocardial infarction or heart surgery up to three months before the survey;
  • Orthopedic diseases, infectious or chronic metabolic diseases;
  • The relation between forced expiratory volume in the first second and forced vital capacity (FEV1 / FVC) <70% of predicted characterizing obstructive respiratory disorder and
  • Active smokers.

结局指标

主要结局

Chest Wall tricompartmental volumes

时间窗: 30 minutes

The images generated by the triangulation of the infra-red light reflected by 89 markers placed over volunteers' chest walls and captured by 8 cameras allows the visualization of the same thoraxes as entire structure and in its own tricompartmental division: pulmonary rib cage (RCp), abdominal rib age (RCab) and abdomen (AB). Each compartment can be evaluated in terms of their volume variation across the recorded respiratory cycle.

Diaphragmatic thickness

时间窗: 30 minutes

A high-definition ultrasound in the the B mode with linear transducer of 7.5 megahertz was used to measure diaphragmatic thickness. In the lateral decubitus position, the transducer was positioned perpendicular to the chest, between the eighth and ninth intercostal spaces between the right anterior and medium axillary lines. Diaphragm was identified by two hyperechoic (bright) lines parallel to the pleural and parietal membranes respectively. The measurement of diaphragm thickness was held from the middle of the pleural line to the middle of peritoneal. The average of 3 final measures taken at the apposition zone obtained: at functional residual capacity (thickness of the relaxed diaphragm - Erel) at the end of the total lung capacity (thickness of the diaphragm contracted - Econt) and during a maximal inspiratory pressure maneuver from functional residual capacity.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniella Cunha Brandao

dbrandao

Universidade Federal de Pernambuco

研究点 (1)

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