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

Innova Smart Technologies (Pvt.) Ltd47 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Chest Pathology

Interventions

NoaScopeDEVICE

Smart digital stethoscope

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Rehman Medical Institute - RMI

Peshawar, Khyber Pakhtunkhwa, Pakistan

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: 1 month

Secondary Outcomes

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.

Time frame: 1 month

Data from ClinicalTrials.gov

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