TerminatedNot Applicable

OxyPrem Validation Study

Stopped: The substudy in premature infants was completed. The substudy in adult volunteers will not be continued, due to previous delays.

Switzerland117 participantsStarted 2010-08-04

Plain-language summary

The precision of the novel diagnostic near-infrared spectroscopy (NIRS) device for the measurement of tissue oxygenation and hemoglobin concentration (OxyPrem) is assessed by repeated measurements. The accuracy of OxyPrem is assessed by comparing the measurement data to those acquired simultaneously by established NIRS devices and standard clinical monitoring devices. In substudy 1, healthy adult subjects are enrolled, in substudy 2, measurements are conducted on preterm neonates.

Who can participate

SexALL

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Substudy 1 (healthy adult volunteers) Inclusion Criteria: * Healthy adult * Signed informed consent Exclusion Criteria: * Dense black hair at the location of measurement * Neurological diseases. Substudy 2 (preterm infants) Inclusion Criteria: * Pre-term neonates (gestational age at birth less than 37 weeks) * Signed informed consent by at least one parent Exclusion Criteria: * Clinically instability * Malformations

What they're measuring

Standard deviation of repeated StO2 level measurements (precision)

Timeframe: baseline

Trial details

NCT IDNCT04860401

SponsorHans Ulrich Bucher

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-21

View on ClinicalTrials.gov More Tissue Oxygenation Measurement trials