Clinical Validation of Tele-stethoscope System Digital

NCT03596541 | Completed

• 1 other identifier: T-stethoscopy
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.)

Conditions

Respiratory Disorder; Heart Disorder

Keywords

Telemedicina; Respiratory sounds; Tele-stethoscopy; Wireless; Real-time; e-health; Heart sounds

Outcome Measures

Primary Outcomes (4)

• 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.

  change from baseline auscultation to final auscultation (after 1 hour)

• 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.

  change from baseline auscultation to final auscultation (after 1 hour)

• 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.

  change from baseline auscultation to final auscultation (after 1 hour)

• 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.

  change from baseline auscultation to final auscultation (after 1 hour)

Secondary Outcomes (4)

• Inter-observer agreement for for heart murmurs auscultation using the two methods (tele-stethoscope and conventional stethoscope)

  change from baseline auscultation to final auscultation (after 1 hour)

• Inter-observer agreement for heart rhythm auscultation using the two methods (tele-stethoscope and conventional stethoscope)

  change from baseline auscultation to final auscultation (after 1 hour)

• Inter-observer agreement for vesicular murmur auscultation using the two methods (tele-stethoscope and conventional stethoscope)

  change from baseline auscultation to final auscultation (after 1 hour)

• Inter-observer agreement for lung rales sounds using the two methods (tele-stethoscope and conventional stethoscope)

  change from baseline auscultation to final auscultation (after 1 hour)

Study Arms (2)

An open real-time tele-stethoscopy system

EXPERIMENTAL

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.

Device: Heart and Respiratory Auscultation of an open real-time tele-stethoscopy system (EHAS-Fundatel digital stethoscope)

Conventional stethoscope

ACTIVE COMPARATOR

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.

Device: Heart and Respiratory Auscultation of an open real-time tele-stethoscopy system (EHAS-Fundatel digital stethoscope)

Interventions

Heart and Respiratory Auscultation of an open real-time tele-stethoscopy system (EHAS-Fundatel digital stethoscope) DEVICE

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.

An open real-time tele-stethoscopy system; Conventional stethoscope

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• The lack of informed consent.
• Inestable disease.

Sponsors & Collaborators

• Sociedad Española de Neumología y Cirugía Torácica: lead

Study Sites (1)

San Pedro de Alcántara Hospital

Cáceres, 10003, Spain

Location

MeSH Terms

Conditions

Respiration Disorders; Heart Diseases; Respiratory Sounds

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jaime Corral, MD

  Hospital San Pedro de Alcántara. Cáceres. Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: June 16, 2014
• First Posted: July 24, 2018
• Study Start: August 27, 2018
• Primary Completion: November 27, 2018
• Study Completion: December 27, 2018
• Last Updated: November 29, 2022

Record last verified: 2022-07

Locations

ES (1)