Evaluation of Wearable Vest for Lung Monitoring

Chronic Lung Disease Clinical Trial

— WELMO  

Official title:

2nd Clinical Trial of WELMO System With Respiratory Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05531539
• Other study ID #: WELMO-THESS
• Status: Completed
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: July 30, 2022

Study information

• Verified date: September 2022
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This was the pilot study of the EU funded research and innovation project WELMO (Wearable Electronics for Effective Lung Monitoring) -Grant agreement number: 825572. The clinical trial involved patients suffering from a variety of respiratory pathological conditions and examined the ease-of-use and efficacy of the WELMO system, comprising a sensors vest for thorax auscultation and recording of Electric Impedance Tomography (EIT) signals and transmitting those on the cloud for review by physicians. The study recruited and briefly monitored 27 patients who underwent brief training and subsequent wearing of the sensors vest for 15-20 minutes, after manual auscultation, spirometry and oximetry. The collected data were transmitted wirelessly to a tablet and then securely to the cloud for review by attending physicians. The usability of the system, the quality of the obtained signals and the validity of the results were evaluated.

Description:

The study recruited and briefly monitored 27 patients at the outpatient department and the medical ward of the Pulmonology Department of "G. Papanikolaou" General Hospital of Thessaloniki, Greece, as well as the 1st Intensive Care Unit of the same Hospital. Patients were recruited during their hospitalization or at the outpatient setting and informed consent was obtained before participation. They were examined with spirometry, manual auscultation of the thorax and where necessary, with chest X-ray or CT scan. They wore the WELMO sensors vest for a period of 15-20 minutes during which they performed tidal and deep breathing, cough and spirometry maneuvers and changes of posture. At the end of the study, they were requested to fill in a questionnaire about comfort and usability of the vest.

Patients from various thoracic disease categories were included from both sexes and aged 18-90 years. The study was approved by the bioethics committee of the Hospital and personal data protection provisions were in place. The obtained signals (lung sounds and EIT signals) were examined for consistency with conventionally obtained medical data and the usability, comfort, patient acceptance and practicality of the WELMO vest was assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 30, 2022
• Est. primary completion date: July 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age >16 years

• Suffering from respiratory disease

• Outpatient at Pulmonology Department of G Papanikolaou Hospital

• Hospitalized at Pulmonology Department of G Papanikolaou Hospital

• Hospitalized at 1st ICU of G Papanikolaou Hospital

Exclusion Criteria:

• Age <16 years

• Skin allergies or broken skin

• Unwilling to provide informed consent

Related Conditions & MeSH terms

• Chronic Lung Disease
• Lung Diseases

Intervention

Device:
• WELMO sensors vest
Wearing of a vest equipped with lung auscultation and EIT sensors for signal acquisition and transmission

Locations

Country	Name	City	State
Greece	1st ICU, "G.Papanikolaou" General Hospital of Thessaloniki, Greece	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki	George Papanicolaou Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (4)

Frerichs I, Lasarow L, Strodthoff C, Vogt B, Zhao Z, Weiler N. Spatial Ventilation Inhomogeneity Determined by Electrical Impedance Tomography in Patients With Chronic Obstructive Lung Disease. Front Physiol. 2021 Dec 13;12:762791. doi: 10.3389/fphys.2021 — View Citation

Frerichs I, Vogt B, Wacker J, Paradiso R, Braun F, Rapin M, Caldani L, Chételat O, Weiler N. Multimodal remote chest monitoring system with wearable sensors: a validation study in healthy subjects. Physiol Meas. 2020 Feb 5;41(1):015006. doi: 10.1088/1361- — View Citation

Kilintzis V, Alexandropoulos VC, Beredimas N, Maglaveras N. A Methodology for an Auto-Generated and Auto-Maintained HL7 FHIR OWL Ontology for Health Data Management. Stud Health Technol Inform. 2021 Nov 18;287:99-103. doi: 10.3233/SHTI210824. — View Citation

Rocha BM, Filos D, Mendes L, Serbes G, Ulukaya S, Kahya YP, Jakovljevic N, Turukalo TL, Vogiatzis IM, Perantoni E, Kaimakamis E, Natsiavas P, Oliveira A, Jácome C, Marques A, Maglaveras N, Pedro Paiva R, Chouvarda I, de Carvalho P. An open access database — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	usability of WELMO vest	Likert type Questionnaire about the usability /patient acceptance/ ease of wearing/ feeling of restriction of respiration/ aesthetic view of the specialized WELMO sensors vest.	1 day for every patient
Secondary	Validity of WELMO vest signals (sounds)	Comparison of the obtained auscultation signals with conventionally acquired biosignals	1 day for every patient
Secondary	Validity of WELMO vest signals (EIT)	Comparison of the obtained auscultation signals with conventionally acquired biosignals	1 day for every patient

External Links

•   Official website of EU funded WELMO project