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

Chest Pathology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05252130
• Other study ID #: NoaScope-1 RMI
• Status: Completed
• Phase: N/A
• Start date: December 22, 2021
• Est. completion date: February 10, 2022

Study information

• Verified date: April 2023
• Source: Innova Smart Technologies (Pvt.) Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: February 10, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Chest Pathology
• Respiratory Sounds

Intervention

Device:
• NoaScope
Smart digital stethoscope

Locations

Country	Name	City	State
Pakistan	Rehman Medical Institute - RMI	Peshawar	KP

Sponsors (3)

Lead Sponsor	Collaborator
Innova Smart Technologies (Pvt.) Ltd	NOABIO LLC, Rehman Medical Institute - RMI

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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