Prospective, Controlled, Open-label Study Evaluating the Keikku Electronic Stethoscope
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Agreement in murmur detection between digital and conventional stethoscopes
研究概览
简要总结
This study is testing a digital stethoscope called the Keikku electronic stethoscope. Doctors use stethoscopes to listen to the heart, and this new device records heart sounds using a smartphone app. The purpose of the study is to check how well this new device works and whether it is safe to use.
The study will include 149 participants of all ages (from birth to 99 years), who are undergoing routine (non-urgent) heart checks. After giving consent, each participant will have their heart sounds listened to twice: once with the Keikku electronic stethoscope and once with a regular stethoscope. Two different doctors will do the listening, and they won't share information with each other. The doctors will record whether they hear a heart murmur and how clear the sounds were.
The study will compare the findings from the new device to those from the regular stethoscope. Researchers will also check for any device problems or side effects. The study takes place at a single site in Peru and will take about one day for each participant.
The goal is to find out if the Keikku electronic stethoscope is accurate and safe for doctors to use in real medical settings.
详细描述
This clinical study is designed to evaluate the performance and safety of the Keikku electronic stethoscope, an innovative medical device developed by Lapsi Health Holding BV. The Keikku device combines a micro-electromechanical system (MEMS) sensor with a Bluetooth-enabled smartphone application, allowing physicians to capture and review heart sounds in real-time or via secure cloud storage.
The Keikku electronic stethoscope differs from traditional stethoscopes in that it digitally records and transmits auscultation sounds without interpreting them. Physicians use the Keikku Mobile Application to listen, annotate, and share these sounds. This study assesses whether such a device can match the diagnostic capabilities of conventional analog stethoscopes, particularly in detecting heart murmurs.
This is a prospective, open-label, controlled clinical investigation involving 149 pediatric and adult participants (from birth to age 99) in non-urgent cardiac evaluations. Each participant undergoes two sequential heart sound assessments at four standard precordial chest locations (mitral, tricuspid, aortic, and pulmonary):
Keikku electronic stethoscope: used by a physician listening via Bluetooth headphones.
Conventional stethoscope: used by a second, blinded physician.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pediatric, including newborn (from birth to 1 month of age), or adult (aged 99 or below) individuals.
- •Individuals who are either:
- •presenting for initial, non-urgent outpatient evaluation of a cardiac murmur or for non-urgent cardiac clearance; or
- •presenting for return, non-urgent outpatient evaluation of a cardiac murmur; or
- •undergoing initial or recurrent, non-urgent evaluation of a cardiac murmur in inpatient setting; or
- •undergoing non-urgent cardiac clearance in inpatient setting.
排除标准
- •pregnant female individuals
结局指标
主要结局
Agreement in murmur detection between digital and conventional stethoscopes
时间窗: Day 0 (Single visit)
Overall agreement (in percent) between the Keikku electronic stethoscope and a conventional analog stethoscope in identifying the presence or absence of a heart murmur.
次要结局
未报告次要终点