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Completed

NCT Number: NCT05531539

Evaluation of Wearable Vest for Lung Monitoring

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.

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Key information

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Thessaloniki, 57010, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WELMO sensors vest

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Validity of WELMO vest signals (sounds)

    Time frame: 1 day for every patient

    Comparison of the obtained auscultation signals with conventionally acquired biosignals

  2. Validity of WELMO vest signals (EIT)

    Time frame: 1 day for every patient

    Comparison of the obtained auscultation signals with conventionally acquired biosignals

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Collaborators

  • George Papanicolaou Hospital

Registry information

Official study title

2nd Clinical Trial of WELMO System With Respiratory Patients

Acronym: WELMO

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 8, 2022
Registry last updated
Sep 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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