Investigation of the functionality of the WELCOME-Vest in healthy volunteers without respiratory disease

Investigation of the functionality of the WELCOME-Vest in healthy volunteers without respiratory disease - WELCOME-Weste

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00010918

Enrollment

Registered

2017-01-11

Start date

2017-01-12

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy subjects

Interventions

Group 1: It will be investigated whether the WELCOME-Weste by means of its integrated sensors generates signals that are plausible as well as in the physiological range for ECG, EIT, SpO 2, lung and h

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: age 18 and above, ability to give consent, signed informed consent form

Exclusion criteria

Exclusion criteria: history of or acute pulmonary disease - pregnant or bresat feeding women (urine pregnancy test) - moderate or severe cardio-vascular disease (e.g. unstable CHD, unstable hypertension, thoracic or abdominal aorta aneurysm) - thoracic deformities - previous trhoracic surgery - severe obesity: Weste will not fit - moderate to severe systemic disease - foreign objects in the thorax: e.g. pace maker, surgical screws or plates in bones - injuries, infections are any diseases that affect the skin - imobile subjects, including wheel chair users and subjects using crutches.

Design outcomes

Primary

Measure	Time frame
Generation of requested signals. The presence of a required signal will be tested for each signal component (ECG, EIT, SpO 2, heart- and lung murmur, physical activity). This test will be conducted at every measurement phase throughout the trial. Plausibility will be confirmed if the generated signals are within the physiological range. Valid evidence for the signal components is as follows: - ECG: a QRS-spike followed by a T-wave is identifiable - heart rate: the follwing range applies: 120/m: not plausible in resting patients - EIT: relative changes in impedance over time: it reflects the periodic respiratory related variation - respiratory rate: the follwing range applies: 45/m: not plausible in resting patients - SpO2: the follwing range applies: <90%: not plausible in healthy volunteers - heart and lung murmur: physiological heart murmur and vesticular respiratory murmur - physical activity: sensed by the sensor during the specific phase.	—

Measure

Time frame

Generation of requested signals. The presence of a required signal will be tested for each signal component (ECG, EIT, SpO 2, heart- and lung murmur, physical activity). This test will be conducted at every measurement phase throughout the trial. Plausibility will be confirmed if the generated signals are within the physiological range. Valid evidence for the signal components is as follows: - ECG: a QRS-spike followed by a T-wave is identifiable - heart rate: the follwing range applies: 120/m: not plausible in resting patients - EIT: relative changes in impedance over time: it reflects the periodic respiratory related variation - respiratory rate: the follwing range applies: 45/m: not plausible in resting patients - SpO2: the follwing range applies: <90%: not plausible in healthy volunteers - heart and lung murmur: physiological heart murmur and vesticular respiratory murmur - physical activity: sensed by the sensor during the specific phase.

—

Secondary

Measure	Time frame
Evaluation of wearing comfort and applicability in healthy volunteers using questionnaires. Safety issues concerning the application of the WELCOME-Vest will be evaluated by the number of Adverse Events (AEs).	—

Countries

Germany

Contacts

Public ContactBarbara Vogt

Klinik für Anästhesiologie und Operative Intensivmedizin

Barbara.vogt@uksh.de0431-50020791

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 17, 2026