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Evaluation of Wearable Vest for Lung Monitoring (WELMO)

Primary Purpose

Chronic Lung Disease

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
WELMO sensors vest
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Lung Disease focused on measuring respiratory disease, lung auscultation, Electric Impedance Tomography, sensors, biosignals acquisition

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Outpatient Respiratory patients

Hospitalized Respiratory patients

Critically ill Respiratory patients

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Validity of WELMO vest signals (sounds)
Comparison of the obtained auscultation signals with conventionally acquired biosignals
Validity of WELMO vest signals (EIT)
Comparison of the obtained auscultation signals with conventionally acquired biosignals

Full Information

First Posted
August 22, 2022
Last Updated
September 7, 2022
Sponsor
Aristotle University Of Thessaloniki
Collaborators
George Papanicolaou Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05531539
Brief Title
Evaluation of Wearable Vest for Lung Monitoring
Acronym
WELMO
Official Title
2nd Clinical Trial of WELMO System With Respiratory Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
July 22, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aristotle University Of Thessaloniki
Collaborators
George Papanicolaou Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lung Disease
Keywords
respiratory disease, lung auscultation, Electric Impedance Tomography, sensors, biosignals acquisition

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Outpatient Respiratory patients
Arm Type
Experimental
Arm Description
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.
Arm Title
Hospitalized Respiratory patients
Arm Type
Experimental
Arm Description
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.
Arm Title
Critically ill Respiratory patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
WELMO sensors vest
Intervention Description
Wearing of a vest equipped with lung auscultation and EIT sensors for signal acquisition and transmission
Primary Outcome Measure Information:
Title
usability of WELMO vest
Description
Likert type Questionnaire about the usability /patient acceptance/ ease of wearing/ feeling of restriction of respiration/ aesthetic view of the specialized WELMO sensors vest.
Time Frame
1 day for every patient
Secondary Outcome Measure Information:
Title
Validity of WELMO vest signals (sounds)
Description
Comparison of the obtained auscultation signals with conventionally acquired biosignals
Time Frame
1 day for every patient
Title
Validity of WELMO vest signals (EIT)
Description
Comparison of the obtained auscultation signals with conventionally acquired biosignals
Time Frame
1 day for every patient

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evangelos Kaimakamis, MD, MSc, PhD
Organizational Affiliation
1st ICU, G. papanikolaou Hospital, Thessaloniki, Greece
Official's Role
Principal Investigator
Facility Information:
Facility Name
1st ICU, "G.Papanikolaou" General Hospital of Thessaloniki, Greece
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30708353
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, 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.
Results Reference
result
PubMed Identifier
31891938
Citation
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.
Results Reference
result
PubMed Identifier
34966289
Citation
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.
Results Reference
result
PubMed Identifier
34795090
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.
Results Reference
result

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Evaluation of Wearable Vest for Lung Monitoring

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