Evaluation of a non-invasive dynamic light scattering sensor for the measurement of heart rate in neonates.
Completed
- Conditions
- prematuriteitpremature birthPrematurity1000590810019815
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 46
Inclusion Criteria
Aged 26 weeks of gestation or older.
Monitored by electrocardiogram in the Neonatal Intensive Care Unit of the Sophia Children*s Hospital.
Written informed consent.
Exclusion Criteria
Absence of written informed consent
A gestational age of < 26 weeks
Skin disorder (including frailty of the skin) for which the double sided skin adhesive is contraindicated.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study endpoint is the correlation of the detection of heart rate in<br /><br>beats per minute between ECG and the Elfi-Tech DLS sensor.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The correlation between flow measured with the Elfi-Tech DLS and Pulse Index<br /><br>(PI) from the pulse oximeter<br /><br>Peak detection and beat to beat analysis for the detection of measurement<br /><br>errors and signal disturbances.<br /><br>Determination of optimal measurement site.<br /><br>Assessment of measurement quality in patient groups with impaired peripheral<br /><br>perfusion; sepsis and therapeutic hypothermia.<br /><br>Heart rate variability measurements with ECG, pulse oximetry and the Elfi-Tech<br /><br>DLS sensor and their correlation.</p><br>