跳至主要内容
临床试验/CTRI/2018/08/015237
CTRI/2018/08/015237已完成不适用

Respiratory sound analysis and correlation with clinical tests and clinical diagnosis

SALCIT TECHNOLOGIES PRIVATE LIMITED1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年3月9日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
2.Test the hypothesis that sound characteristics have correlation with clinical test like spirometry and associated parameters, bed side lung function tests and clinical diagnosis.

研究概览

简要总结

This is a validation study to analyze the data delivered by the study device and correlate with clinical tests and diagnosis. This study will analyze the respiratory sounds characteristics of the patients suffering from various chronic respiratory diseases, pulmonary tuberculosis, and congestive heart failure.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Written signed and dated informed consent (patient or LAR)
  • Either gender with age 18 years and above.
  • Subjects suffering with CRD’s, Pulmonary Tuberculosis, CHF and Pulmonary Fibrosis.

排除标准

  • Subjects who require ventilation, flow of oxygen must be excluded from the study.

结局指标

主要结局

2.Test the hypothesis that sound characteristics have correlation with clinical test like spirometry and associated parameters, bed side lung function tests and clinical diagnosis.

时间窗: For each subject minimum of 5 records are required for in-patients. | 2 records on the first and second day of admission. | 2 records during course of treatment (after first or second day and prior to discharge) | 1 record during discharge (or during stable state) | For each outpatient a minimum of 2 records will be attempted.

1. Test the hypothesis that the sound characteristics differ for various CRDs. Sound characteristics can be used in determining severity of inflammation.

时间窗: For each subject minimum of 5 records are required for in-patients. | 2 records on the first and second day of admission. | 2 records during course of treatment (after first or second day and prior to discharge) | 1 record during discharge (or during stable state) | For each outpatient a minimum of 2 records will be attempted.

次要结局

  • Test the hypothesis that sound characteristics have correlation with clinical test like spirometry and associated parameters, bed side lung function tests and clinical diagnosis.(For each subject minimum of 5 records are required for in-patients.)

研究者

发起方
SALCIT TECHNOLOGIES PRIVATE LIMITED
申办方类型
Other [IT COMPANY WHICH IS INTO HEALTH CARE SERVICES]

研究点 (1)

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