NCT05531539

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2022

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 8, 2022

Completed
Last Updated

September 10, 2022

Status Verified

September 1, 2022

Enrollment Period

6 months

First QC Date

August 22, 2022

Last Update Submit

September 7, 2022

Conditions

Chronic Lung Disease

Keywords

respiratory diseaselung auscultationElectric Impedance Tomographysensorsbiosignals acquisition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Validity of WELMO vest signals (sounds)

    1 day for every patient

  • Validity of WELMO vest signals (EIT)

    1 day for every patient

Study Arms (3)

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.

Device: WELMO sensors vest

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.

Device: WELMO sensors vest

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.

Device: WELMO sensors vest

Interventions

WELMO sensors vestDEVICE

Wearing of a vest equipped with lung auscultation and EIT sensors for signal acquisition and transmission

Critically ill Respiratory patientsHospitalized Respiratory patientsOutpatient Respiratory patients

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age \<16 years
  • Skin allergies or broken skin
  • Unwilling to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Thessaloniki, 57010, Greece

Location

Related Publications (4)

  • 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.

    PMID: 30708353RESULT

  • 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.

    PMID: 31891938RESULT

  • 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.

    PMID: 34966289RESULT

  • 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.

    PMID: 34795090RESULT

Related Links

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Evangelos Kaimakamis, MD, MSc, PhD

    1st ICU, G. papanikolaou Hospital, Thessaloniki, Greece

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2022

First Posted

September 8, 2022

Study Start

January 10, 2022

Primary Completion

July 22, 2022

Study Completion

July 30, 2022

Last Updated

September 10, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)