Evaluation of Wearable Vest for Lung Monitoring

Not Applicable

Completed

• Conditions: Chronic Lung Disease
• Interventions: Device: WELMO sensors vest

• Registration Number: NCT05531539
• Lead Sponsor: Aristotle University Of Thessaloniki

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.

Study Timeline

• Study Start: 2022-01-10
• Primary Completion: 2022-07-22
• Study Completion: 2022-07-30
• Study First Submitted: 2022-08-22
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-02
• Last Update Submitted: 2022-09-07
• Study First Posted: 2022-09-08
• Last Update Posted: 2022-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hospitalized Respiratory patients	WELMO sensors 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.
Outpatient Respiratory patients	WELMO sensors 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.
Critically ill Respiratory patients	WELMO sensors 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.

Primary Outcome Measures

Name	Time	Method
usability of WELMO vest	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.

Secondary Outcome Measures

Name	Time	Method
Validity of WELMO vest signals (EIT)	1 day for every patient	Comparison of the obtained auscultation signals with conventionally acquired biosignals
Validity of WELMO vest signals (sounds)	1 day for every patient	Comparison of the obtained auscultation signals with conventionally acquired biosignals

Trial Locations

Locations (1)

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