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Completed

NCT Number: NCT05252130

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

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

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Key information

Conditions

Chest Pathology

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehman Medical Institute - RMI

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NoaScope

Device

Smart digital stethoscope

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. Difference in performance between subgroups of doctors based on clinical experience.

    Time frame: 1 month

    This will be estimated as a proportion difference of correctly identified heart and lung sounds for each doctor subgroup.

Sponsors and collaborators

Lead sponsor

Innova Smart Technologies (Pvt.) Ltd

Other

Collaborators

  • NOABIO LLC
  • Rehman Medical Institute - RMI

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 23, 2022
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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