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| Name | Class |
|---|---|
| George Papanicolaou Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Outpatient Respiratory patients | Experimental | 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. |
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| Hospitalized Respiratory patients | Experimental | 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. |
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| Critically ill Respiratory patients | Experimental | They were examined with 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 the vest recorded the breathing provided by the mechanical ventilator. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WELMO sensors vest | Device | Wearing of a vest equipped with lung auscultation and EIT sensors for signal acquisition and transmission |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Validity of WELMO vest signals (sounds) | Comparison of the obtained auscultation signals with conventionally acquired biosignals | 1 day for every patient |
| Validity of WELMO vest signals (EIT) | Comparison of the obtained auscultation signals with conventionally acquired biosignals |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evangelos Kaimakamis, MD, MSc, PhD | 1st ICU, G. papanikolaou Hospital, Thessaloniki, Greece | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1st ICU, "G.Papanikolaou" General Hospital of Thessaloniki, Greece | Thessaloniki | 57010 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30708353 | Result | 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, Jacome C, Marques A, Maglaveras N, Pedro Paiva R, Chouvarda I, de Carvalho P. An open access database for the evaluation of respiratory sound classification algorithms. Physiol Meas. 2019 Mar 22;40(3):035001. doi: 10.1088/1361-6579/ab03ea. | |
| 31891938 |
| Label | URL |
|---|---|
| Official website of EU funded WELMO project | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 10, 2022 | Sep 2, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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| 1 day for every patient |
| Result |
| Frerichs I, Vogt B, Wacker J, Paradiso R, Braun F, Rapin M, Caldani L, Chetelat 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: 10.1088/1361-6579/ab668f. |
| 34966289 | Result | 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.2021.762791. eCollection 2021. |
| 34795090 | Result | 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. |