Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Rehman Medical Institute - RMI | OTHER |
| NOABIO LLC | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auscultation with a newly developed electronic stethoscope: NoaScope | Experimental | Identification of abnormal heart and lung sounds in study participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NoaScope | Device | Smart digital stethoscope |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehman Medical Institute - RMI | Peshawar | Khyber Pakhtunkhwa | 25000 | Pakistan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided