Clinical validation of vital signs measured by the Vital Signs Monitoring System in a controlled environment

Clinical validation of vital signs measured by the Vital Signs Monitoring System in a controlled environment - Clinical validation of vital signs monitoring

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50709

Enrollment

Registered

2021-12-20

Start date

2022-01-31

Completion date

Unknown

Last updated

2025-09-08

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

Conditions

n.v.t. n/a

Interventions

The subjects will undergo a controlled desaturation procedure and respiratory rate procedure. Total participating time is approximately 2.5 hours (excluding breaks between measurements).

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Aged 18 to 50 years old - ASA category 1: a normal healthy subject. Example: fit, nonobese (BMI under 30), non-smoking with good exercise tolerance - No hypertension

Exclusion criteria

Exclusion criteria: - Inability to give informed consent - At risk during hypoxia due to medical conditions (e.g. cardiovascular or pulmonary disease) - Pregnant or braestfeeding

Design outcomes

Primary

Measure	Time frame
The primary outcome is the accuracy of the device under investigation to determine functional oxygen saturation as compared to a reference device and to determine respiratory rate as compared to visual observations.	—

Secondary

Measure	Time frame
The secondary outcome is the accuracy of the device under investigation to determine respiratory rate compared to a reference device.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)