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临床试验/NCT00362401
NCT00362401已完成不适用

Patients Perception of Mechanical Heart Valve Sounds: Psychoacoustics and Quality of Life

University of Aarhus1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2005年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Intensity (Highness) of the Sound From Mechanical Heart Valves

研究概览

简要总结

The purpose of this study is to compare the sound pressure levels (SPLs) from three of the most frequently implanted mechanical heart valve prostheses, in order to determine whether there was any significant difference between the intensities of the valve sounds

详细描述

Patient's perception of mechanical heart valve sounds: psychoacoustics and quality of life

Background: Approximately 90.000 mechanical prosthetic heart valves are implanted every year all over the world. They generate a clicking sound at closure, which can be a major problem for some patients. About 12% of them all experience annoyance, concentration disturbance, sleeping disorders and social embarrassment. All those factors could affect patients' quality of life.

Aim: to compare the sound pressure levels (SPLs) from three of the most frequently implanted mechanical heart valve prostheses, in order to determine whether there was any significant difference between the intensities of the valve sounds.

Material and Methods: We intended to include 150 patients with an implanted mechanical heart valve (ATS Medical, Medtronic-Hall or St. Jude Medical) in the aortic position between 3 months and 4 years before the analysis. For logistical reasons, the actual number of the patients included was 84. The total conducted valve sound was measured (by a method designed by the authors) for each patient. The measures took place in a bioacoustical laboratory built with a sound-insulated chamber with a very low background noise, designed for the purposes of the study. The measures were performed in German patients followed by "The Heart Centre" in Bad Oeynhausen (Herz- und Diabeteszentrum Nordrhein Westfalen, University of Bochum), where the mentioned laboratory is constructed. The sound analysis of the present study was conducted in a specially designed soundproof bioacoustic laboratory, which isolates the outside sound and vibration from the environment indoors. Inside the laboratory, heavy soundinsulated curtains were placed between the patient and the investigator chambers. The total background noise inside the patient chamber was 19 dB(A), and this was reduced further to 9 dB(A) by using a 250 Hz high-pass filter. The sounds were recorded with the patient in the supine position, and without clothes covering the chest. The valve closing sounds were recorded using a microphone (Brüel and Kjær 4179) placed 5 cm above the patient's chest. This sound was then preamplified (Brüel and Kjær 2660), amplified (Brüel and Kjær 2610) and 250 Hz high-pass filtered (Krohn-Hite 3944) (see Fig. 1). All valve sounds were recorded by the same experienced investigator and stored on an instrumentation recorder (TEAC 510) for later off-line analysis. The data acquisition time for each patient was approximately 10 min.

The patients were asked to fuldill a quality of life questionnaire (SF-36), which will be assessed in a future study regarding psychoacoustics for mechanical heart valve sounds.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • Adult patients (18 years of age and older) with an aortic mechanical heart valve which belongs to one of the three investigated valve types and have been implanted from three months to four years before the investigation.

排除标准

  • Patients with severe hearing impairment (evaluated by a conventional audiogram inside the sound-insulated chamber) or who use hearing aid;
  • patients with severe cardiac arrhythmias;
  • patients with claustrophobia;
  • patients who are not capable of cooperating to the experimental conditions at a sound-insulated chamber;
  • patients who are unable to fulfil the quality of life questionnaire.

结局指标

主要结局

Intensity (Highness) of the Sound From Mechanical Heart Valves

时间窗: 10.06.2007

The measurements took place in a Bioacoustic laboratory. The total background noise was 9 dB(A). The valve closing sounds were recorded by a microphone placed 5 cm above the patient's chest. This sound was pre-amplified, amplified, filtered and stored on an instrumentation recorder for later off-line analysis.

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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