OxyPrem Validation Study

Not Applicable

Terminated

• Conditions: Tissue Oxygenation Measurement
• Interventions: Device: Measurement of tissue oxygenation with novel diagnostic near-infrared spectroscopy device (OxyPrem) (no clinical decisions based on oxygenation levels)

• Registration Number: NCT04860401
• Lead Sponsor: Hans Ulrich Bucher

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-04
• Study First Submitted: 2021-04-15
• Study First Submitted QC: 2021-04-21
• Study First Posted: 2021-04-27
• Primary Completion: 2022-06-21
• Study Completion: 2022-06-21
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 117

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
precision and accuracy study	Measurement of tissue oxygenation with novel diagnostic near-infrared spectroscopy device (OxyPrem) (no clinical decisions based on oxygenation levels)	precision and accuracy of Oxyprem are studied

Primary Outcome Measures

Name	Time	Method
Standard deviation of repeated StO2 level measurements (precision)	baseline	The precision of the StO2 measurement is the reproducibility within multiple consecutive measurements under similar conditions, expressed as the standard deviation of repeated measurements.

Trial Locations

Locations (1)

University Hospital of Zurich; 🇨🇭 Zürich, Zurich, Switzerland