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

Not Applicable

Completed

• Conditions: Chest Pathology
• Interventions: Device: NoaScope

• Registration Number: NCT05252130
• Lead Sponsor: Innova Smart Technologies (Pvt.) Ltd

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

Study Timeline

• Study Start: 2021-12-22
• Study First Submitted: 2021-12-24
• Primary Completion: 2022-01-31
• Study First Submitted QC: 2022-02-09
• Study Completion: 2022-02-10
• Study First Posted: 2022-02-23
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-04
• Last Update Posted: 2023-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Auscultation with a newly developed electronic stethoscope: NoaScope	NoaScope	Identification of abnormal heart and lung sounds in study participants

Primary Outcome Measures

Name	Time	Method
The measurement of sound quality in a clinical setting by means of an MOS scale on a questionnaire.	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.	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 Outcome Measures

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

Trial Locations

Locations (1)

Rehman Medical Institute - RMI; 🇵🇰 Peshawar, KP, Pakistan