Comparison of NoaScope to the Conventional Stethoscope for Auscultation of Heart and Lung Sounds

Study Overview
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Brief Summary
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Assessing non-inferiority of a newly developed electronic stethoscope NoaScope in comparison with the conventional 3M Littmann stethoscope

Detailed Description
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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

Official Title
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Comparison of NoaScope to the Conventional Stethoscope for Auscultation of Heart and Lung Sounds

Conditions
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Chest Pathology

Intervention / Treatment
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* Device: NoaScope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages: 18 years or older (male and female) Hospital admitted or Out Patient Department Written consent provided Exclusion Criteria: Age <18 ICU admitted Written consent not provided

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Auscultation with a newly developed electronic stethoscope: NoaScope<br>Identification of abnormal heart and lung sounds in study participants | Device: NoaScope<br>* Smart digital stethoscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correctly identified abnormal heart and lung sounds by doctors using two stethoscopes: NoaScope and 3M™️ Littmann®️ Classic III. | 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. | 1 month | 
| The measurement of sound quality in a clinical setting by means of an MOS scale on a questionnaire. | The investigators will measure sound quality on a mean opinion score scale with values ranging form 1 (bad) to 5 (excellent). | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in performance between subgroups of doctors based on clinical experience. | This will be estimated as a proportion difference of correctly identified heart and lung sounds for each doctor subgroup. | 1 month |