Evaluation of Wearable Vest for Lung Monitoring

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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2nd Clinical Trial of WELMO System With Respiratory Patients

Conditions
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Chronic Lung Disease

Intervention / Treatment
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* Device: WELMO sensors vest


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Outpatient Respiratory patients<br>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. | Device: WELMO sensors vest<br>* Wearing of a vest equipped with lung auscultation and EIT sensors for signal acquisition and transmission<br>|
| Experimental: Hospitalized Respiratory patients<br>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. | Device: WELMO sensors vest<br>* Wearing of a vest equipped with lung auscultation and EIT sensors for signal acquisition and transmission<br>|
| Experimental: Critically ill Respiratory patients<br>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. | Device: WELMO sensors vest<br>* Wearing of a vest equipped with lung auscultation and EIT sensors for signal acquisition and transmission<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 1 day for every patient | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biosignals acquisition, respiratory disease, lung auscultation, Electric Impedance Tomography, sensors