Comparison of NoaScope to the Conventional Stethoscope for Auscultation of Heart and Lung Sounds
Primary Purpose
Chest Pathology
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
NoaScope
Sponsored by
About this trial
This is an interventional diagnostic trial for Chest Pathology
Eligibility Criteria
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
Sites / Locations
- Rehman Medical Institute - RMI
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Auscultation with a newly developed electronic stethoscope: NoaScope
Arm Description
Identification of abnormal heart and lung sounds in study participants
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05252130
First Posted
December 24, 2021
Last Updated
April 4, 2023
Sponsor
Innova Smart Technologies (Pvt.) Ltd
Collaborators
Rehman Medical Institute - RMI, NOABIO LLC
1. Study Identification
Unique Protocol Identification Number
NCT05252130
Brief Title
Comparison of NoaScope to the Conventional Stethoscope for Auscultation of Heart and Lung Sounds
Official Title
Comparison of NoaScope to the Conventional Stethoscope for Auscultation of Heart and Lung Sounds
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 22, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
February 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innova Smart Technologies (Pvt.) Ltd
Collaborators
Rehman Medical Institute - RMI, NOABIO LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pathology
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Auscultation with a newly developed electronic stethoscope: NoaScope
Arm Type
Experimental
Arm Description
Identification of abnormal heart and lung sounds in study participants
Intervention Type
Device
Intervention Name(s)
NoaScope
Intervention Description
Smart digital stethoscope
Primary Outcome Measure Information:
Title
Correctly identified abnormal heart and lung sounds by doctors using two stethoscopes: NoaScope and 3M™️ Littmann®️ Classic III.
Description
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
Title
The measurement of sound quality in a clinical setting by means of an MOS scale on a questionnaire.
Description
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 Outcome Measure Information:
Title
Difference in performance between subgroups of doctors based on clinical experience.
Description
This will be estimated as a proportion difference of correctly identified heart and lung sounds for each doctor subgroup.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Rehman Medical Institute - RMI
City
Peshawar
State/Province
KP
ZIP/Postal Code
25000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of NoaScope to the Conventional Stethoscope for Auscultation of Heart and Lung Sounds
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