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Automated spot-check respiration and pulse monitoring for 5-18 year old patients

Automated spot-check respiration and pulse monitoring for 5-18 year old patients - Accelerometry for Vital Signs Measurement (AVSM)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON40772
Enrollment
60
Registered
2014-12-29
Start date
2015-03-20
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

vital signals monitoring monitoring signals

Interventions

None listed

Sponsors

Philips Research
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: Patients of MMC- pediatric department -Age between 5 and 18 years old -Subjects must be able to provide an informed consent or have legally authorized representative consent to participate -Subjects of 12 years and older must provide assent to participate -Subjects are hospitalized patients of the pediatric department of MMC and stay there for at least 24 hours.

Exclusion criteria

Exclusion criteria: Exclusion criteria for subject selection * Subjects with deformations that prevent proper device positioning * Subjects with arrhythmia * Subjects who had rib surgery * Subjects with skin irritation that prevent 24 hours wearing the device * Subjects having implants or devices connected that might be affected by the bioimpedance measurement.

Design outcomes

Primary

MeasureTime frame
Primary objective: The primary objective is obtaining motion sensor data for performance validation of a respiration rate and pulse rate monitoring algorithm for use on 5-18 years old patients. The data collected using the motion sensor of this study will be compared with the one obtained using the golden standard for respiratory frequency ( by using a respiration band) and heart rate (by using ECG) .

Secondary

MeasureTime frame
The secondary objective is obtaining motion sensor data for the development and improvement of respiration rate and pulse rate detection algorithms specific for 5-18 years old patients.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)