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Clinical Validation of Tele-stethoscope System Digital (TeleCáceres)

Primary Purpose

Respiratory Disorder, Heart Disorder

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Heart and Respiratory Auscultation of an open real-time tele-stethoscopy system (EHAS-Fundatel digital stethoscope)
Sponsored by
Sociedad Española de Neumología y Cirugía Torácica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Respiratory Disorder focused on measuring Telemedicina, Respiratory sounds, Tele-stethoscopy, Wireless, Real-time, e-health, Heart sounds

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Informed consent sign.
  • Pacient admitted to hospital with any disease but no inestable disease.

Exclusion Criteria:

  • The lack of informed consent.
  • Inestable disease.

Sites / Locations

  • San Pedro de Alcántara Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

An open real-time tele-stethoscopy system

Conventional stethoscope

Arm Description

EHAS-Fundatel digital stethoscope is an open real-time tele-stethoscopy system. The interventions in this arm will be to make a respiratory and heart auscultation with this tele-stethoscope. After that, we will do the comparison or agreetment between the auscultation of two protocols: tele-stethoscopy system and conventional stethoscope.

Conventional stethoscope used is the 3M Littmann Classic II S.E. stethoscope. The interventions in this arm will be to make a respiratory and heart auscultation with this conventional stethoscope. After that we will do the comparison or agreetment between the ascultation of two protocols: conventional stethoscope and tele-stethoscopy system.

Outcomes

Primary Outcome Measures

Intra-observer agreement for heart murmurs auscultation using the two methods (tele-stethoscope and conventional stethoscope)
The investigators will randomize the first auscultation (baseline auscultation) into tele-stethoscope system or conventional stethoscope. After 1 hour, we will use the other auscultation method. The investigators will measure if there is a heart murmur or not and the intra-observer agreement by the kappa index in the heart murmurs auscultation.
Intra-observer agreement for heart rhythm auscultation using the two methods (tele-stethoscope and conventional stethoscope)
The investigators will measure if there is a heart rhythm auscultation or not rhythm and the intra-observer agreement by the kappa index in the heart rhythm auscultation.
Intra-observer agreement for vesicular murmur auscultation using the two methods (tele-stethoscope and conventional stethoscope)
The investigators will measure if there is a normal vesicular murmur or not and the intra-observer agreement by the kappa index in the vesicular murmur auscultation.
Intra-observer agreement for lung rales sounds using the two methods (tele-stethoscope and conventional stethoscope)
The investigators will measure if there is a lung rale sound or not and the intra-observer agreement by the kappa index in the lung rale sound.

Secondary Outcome Measures

Inter-observer agreement for for heart murmurs auscultation using the two methods (tele-stethoscope and conventional stethoscope)
The investigators will randomize the first auscultation (baseline auscultation) into tele-stethoscope system or conventional stethoscope. After 1 hour, we will use the other auscultation method. The investigators will measure if there is a heart murmur or not and the inter-observer agreement by the kappa index in the heart murmurs auscultation.
Inter-observer agreement for heart rhythm auscultation using the two methods (tele-stethoscope and conventional stethoscope)
The investigators will measure if there is a heart rhythm auscultation or not rhythm and the inter-observer agreement by the kappa index in the heart rhythm auscultation.
Inter-observer agreement for vesicular murmur auscultation using the two methods (tele-stethoscope and conventional stethoscope)
The investigators will measure if there is a normal vesicular murmur or not and the inter-observer agreement by the kappa index in the vesicular murmur auscultation.
Inter-observer agreement for lung rales sounds using the two methods (tele-stethoscope and conventional stethoscope)
The investigators will measure if there is a lung rale sound or not and the inter-observer agreement by the kappa index in the lung rale sound.

Full Information

First Posted
June 16, 2014
Last Updated
November 22, 2022
Sponsor
Sociedad Española de Neumología y Cirugía Torácica
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1. Study Identification

Unique Protocol Identification Number
NCT03596541
Brief Title
Clinical Validation of Tele-stethoscope System Digital
Acronym
TeleCáceres
Official Title
Clinical Validation of Tele-stethoscope System Digital Bluetooth Ehas-fundatel
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
August 27, 2018 (Actual)
Primary Completion Date
November 27, 2018 (Actual)
Study Completion Date
December 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sociedad Española de Neumología y Cirugía Torácica

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Acute respiratory infections and other respiratory and cardiology diseases like COPD or heart failure are important causes of morbidity and mortality around the world. Telemedicine is defined as the delivery of health care and the sharing of medical knoledge over distances using telecommunication systems. Inexpensive techologies offer the possibility of a direct, real-time connection between the patient or the other end. These technologies help to the physicians to manage different symptoms and cardio-respiratory diseases. A real-time wireless tele-stethoscopy system was designed to allow a physician to receive real-time cardio-respiratory sounds from a remote auscultation, as well as video images showing where the technician is placing the stethoscope on the patient´s body. Actually, the lack of physicians in rural areas of developing countries makes difficult their correct diagnosis and treatment. Furthermore, in the majority of health systems, the patients are shared between primary care and medical specialty in hospitals. The tele-stethoscopy system through telemedicine could help to the physicians or health-care technicians in the majority of health systems and especially in rural areas of developing countries without physicians to manage the patients. For this reason, the goal of this project is the clinical validation of an open real-time tele-stethoscope systme (EHAS-Fundatel digital stethoscope) previously designed, with different specialist (pneumologists, cardiologists and internists.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Disorder, Heart Disorder
Keywords
Telemedicina, Respiratory sounds, Tele-stethoscopy, Wireless, Real-time, e-health, Heart sounds

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
An open real-time tele-stethoscopy system
Arm Type
Experimental
Arm Description
EHAS-Fundatel digital stethoscope is an open real-time tele-stethoscopy system. The interventions in this arm will be to make a respiratory and heart auscultation with this tele-stethoscope. After that, we will do the comparison or agreetment between the auscultation of two protocols: tele-stethoscopy system and conventional stethoscope.
Arm Title
Conventional stethoscope
Arm Type
Active Comparator
Arm Description
Conventional stethoscope used is the 3M Littmann Classic II S.E. stethoscope. The interventions in this arm will be to make a respiratory and heart auscultation with this conventional stethoscope. After that we will do the comparison or agreetment between the ascultation of two protocols: conventional stethoscope and tele-stethoscopy system.
Intervention Type
Device
Intervention Name(s)
Heart and Respiratory Auscultation of an open real-time tele-stethoscopy system (EHAS-Fundatel digital stethoscope)
Intervention Description
We compare the respiratory and heart auscultation of clinicians using the EHAS-Fundatel digital stethoscope and a conventional stethoscope and we will observe; inter-observer and intra-observer differences by two auscultation methods.
Primary Outcome Measure Information:
Title
Intra-observer agreement for heart murmurs auscultation using the two methods (tele-stethoscope and conventional stethoscope)
Description
The investigators will randomize the first auscultation (baseline auscultation) into tele-stethoscope system or conventional stethoscope. After 1 hour, we will use the other auscultation method. The investigators will measure if there is a heart murmur or not and the intra-observer agreement by the kappa index in the heart murmurs auscultation.
Time Frame
change from baseline auscultation to final auscultation (after 1 hour)
Title
Intra-observer agreement for heart rhythm auscultation using the two methods (tele-stethoscope and conventional stethoscope)
Description
The investigators will measure if there is a heart rhythm auscultation or not rhythm and the intra-observer agreement by the kappa index in the heart rhythm auscultation.
Time Frame
change from baseline auscultation to final auscultation (after 1 hour)
Title
Intra-observer agreement for vesicular murmur auscultation using the two methods (tele-stethoscope and conventional stethoscope)
Description
The investigators will measure if there is a normal vesicular murmur or not and the intra-observer agreement by the kappa index in the vesicular murmur auscultation.
Time Frame
change from baseline auscultation to final auscultation (after 1 hour)
Title
Intra-observer agreement for lung rales sounds using the two methods (tele-stethoscope and conventional stethoscope)
Description
The investigators will measure if there is a lung rale sound or not and the intra-observer agreement by the kappa index in the lung rale sound.
Time Frame
change from baseline auscultation to final auscultation (after 1 hour)
Secondary Outcome Measure Information:
Title
Inter-observer agreement for for heart murmurs auscultation using the two methods (tele-stethoscope and conventional stethoscope)
Description
The investigators will randomize the first auscultation (baseline auscultation) into tele-stethoscope system or conventional stethoscope. After 1 hour, we will use the other auscultation method. The investigators will measure if there is a heart murmur or not and the inter-observer agreement by the kappa index in the heart murmurs auscultation.
Time Frame
change from baseline auscultation to final auscultation (after 1 hour)
Title
Inter-observer agreement for heart rhythm auscultation using the two methods (tele-stethoscope and conventional stethoscope)
Description
The investigators will measure if there is a heart rhythm auscultation or not rhythm and the inter-observer agreement by the kappa index in the heart rhythm auscultation.
Time Frame
change from baseline auscultation to final auscultation (after 1 hour)
Title
Inter-observer agreement for vesicular murmur auscultation using the two methods (tele-stethoscope and conventional stethoscope)
Description
The investigators will measure if there is a normal vesicular murmur or not and the inter-observer agreement by the kappa index in the vesicular murmur auscultation.
Time Frame
change from baseline auscultation to final auscultation (after 1 hour)
Title
Inter-observer agreement for lung rales sounds using the two methods (tele-stethoscope and conventional stethoscope)
Description
The investigators will measure if there is a lung rale sound or not and the inter-observer agreement by the kappa index in the lung rale sound.
Time Frame
change from baseline auscultation to final auscultation (after 1 hour)

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: Informed consent sign. Pacient admitted to hospital with any disease but no inestable disease. Exclusion Criteria: The lack of informed consent. Inestable disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaime Corral, MD
Organizational Affiliation
Hospital San Pedro de Alcántara. Cáceres. Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Pedro de Alcántara Hospital
City
Cáceres
ZIP/Postal Code
10003
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Clinical Validation of Tele-stethoscope System Digital

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