Keikku electronic stethoscope for recording heart sounds and detecting murmurs and wheezing
Prospective, Controlled, Open-label Study Evaluating the Keikku Electronic Stethoscope
Lapsi Health Holding B.V. · NCT07044128
We will test whether the Keikku electronic stethoscope can accurately record heart sounds and help doctors detect heart murmurs and wheezing in people of all ages during routine, non-urgent heart checks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 149 (estimated) |
| Ages | N/A to 99 Years |
| Sex | All |
| Sponsor | Lapsi Health Holding B.V. (industry) |
| Locations | 1 site (Lima) |
| Trial ID | NCT07044128 on ClinicalTrials.gov |
What this trial studies
This prospective, open-label, controlled investigation will enroll 149 participants from newborns through age 99 at a single site in Lima, Peru. Each participant will have sequential auscultation at four standard precordial locations using the Keikku electronic stethoscope (with Bluetooth headphones) and a conventional stethoscope performed by a second, blinded physician. Physicians will independently record whether a murmur is present and rate acoustic quality on a 5-point Likert scale, while researchers monitor for device issues or adverse events. The study compares the diagnostic findings between the digital device and standard analog auscultation without automated interpretation of recordings.
Who should consider this trial
Good fit: People from birth through age 99 who are undergoing non-urgent outpatient or inpatient cardiac evaluation or cardiac clearance for a suspected or known murmur are the intended participants; pregnant individuals are excluded.
Not a fit: Patients with urgent or emergency cardiac conditions and pregnant individuals are not eligible and are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, the device could allow clinicians to reliably record and share high-quality heart sounds for diagnosis and remote review, which may improve detection and follow-up of murmurs.
How similar studies have performed: Prior studies of electronic/digital stethoscopes have frequently shown comparable murmur detection to analog stethoscopes, but results depend on device design and setting, so direct evidence for this specific device is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: pregnant female individuals
Where this trial is running
Lima
- Clinica Internacional San Borja — Lima, Peru (RECRUITING)
Study contacts
- Study coordinator: Alfredo Gilberto Guerreros Benavides
- Email: alfgb@yahoo.es
- Phone: +51 1 6196161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Murmurs, Wheezing, Stethoscopes, Cardiac Auscultation, Diagnostic Techniques and Procedures, Medical Device Evaluation, Sound Recording and Reproduction, Pediatric Cardiology