Comparison of NoaScope to the Conventional Stethoscope for Auscultation of Heart and Lung Sounds
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chest Pathology
- Sponsor
- Innova Smart Technologies (Pvt.) Ltd
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- The measurement of sound quality in a clinical setting by means of an MOS scale on a questionnaire.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
Assessing non-inferiority of a newly developed electronic stethoscope NoaScope in comparison with the conventional 3M Littmann stethoscope
Detailed Description
The enrolled population will include adults with a history of heart and lung complications. The enhanced sound quality of the electronic stethoscope and its non-inferiority to the traditional/conventional 3M Littmann stethoscope will be assessed through auscultation examination of every patient by a health professional (consultant, medical resident, and house officer) with both the electronic stethoscope and 3M Littmann/traditional/conventional stethoscope
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ages: 18 years or older (male and female)
- •Hospital admitted or Out Patient Department
- •Written consent provided
Exclusion Criteria
- •ICU admitted
- •Written consent not provided
Outcomes
Primary Outcomes
The measurement of sound quality in a clinical setting by means of an MOS scale on a questionnaire.
Time Frame: 1 month
The investigators will measure sound quality on a mean opinion score scale with values ranging form 1 (bad) to 5 (excellent).
Correctly identified abnormal heart and lung sounds by doctors using two stethoscopes: NoaScope and 3M™️ Littmann®️ Classic III.
Time Frame: 1 month
Each patient will receive two auscultation examinations: one with NoaScope and another with 3M™️ Littmann®️ Classic III. The investigators will determine the clinical feasibility and non-inferiority of NoaScope to the FDA-approved 3M™️ Littmann®️ Classic III from auscultation findings (heart and lungs) by doctors (holding varied levels of clinical expertise). Doctors will examine each patient using two stethoscopes: NoaScope and 3M™️ Littmann®️ Classic III. The investigators will also measure inter and intra observer agreement by the Kappa index with the help of a questionnaire. Kappa values \< 0.8 means weak to moderate level of agreement and Kappa values between 0.8 - 1.0 would mean strong level of agreement.
Secondary Outcomes
- Difference in performance between subgroups of doctors based on clinical experience.(1 month)