Evaluation of Wearable Vest for Lung Monitoring (WELMO)

September 7, 2022 updated by: Aristotle University Of Thessaloniki

2nd Clinical Trial of WELMO System With Respiratory Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 57010
        • 1st ICU, "G.Papanikolaou" General Hospital of Thessaloniki, Greece

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Outpatient Respiratory patients
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
Wearing of a vest equipped with lung auscultation and EIT sensors for signal acquisition and transmission
Experimental: Hospitalized Respiratory patients
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
Wearing of a vest equipped with lung auscultation and EIT sensors for signal acquisition and transmission
Experimental: Critically ill Respiratory patients
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
Wearing of a vest equipped with lung auscultation and EIT sensors for signal acquisition and transmission

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
usability of WELMO vest
Time Frame: 1 day for every patient
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)
Time Frame: 1 day for every patient
Comparison of the obtained auscultation signals with conventionally acquired biosignals
1 day for every patient
Validity of WELMO vest signals (EIT)
Time Frame: 1 day for every patient
Comparison of the obtained auscultation signals with conventionally acquired biosignals
1 day for every patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Collaborators

George Papanicolaou Hospital

Investigators

  • Principal Investigator: Evangelos Kaimakamis, MD, MSc, PhD, 1st ICU, G. papanikolaou Hospital, Thessaloniki, Greece

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2022

Primary Completion (Actual)

July 22, 2022

Study Completion (Actual)

July 30, 2022

Study Registration Dates

First Submitted

August 22, 2022

First Submitted That Met QC Criteria

September 2, 2022

First Posted (Actual)

September 8, 2022

Study Record Updates

Last Update Posted (Actual)

September 10, 2022

Last Update Submitted That Met QC Criteria

September 7, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WELMO-THESS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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