OxyPrem Validation Study

Hans Ulrich Bucher

Status: Terminated

Conditions: Tissue Oxygenation Measurement

Treatments: Device: Measurement of tissue oxygenation with novel diagnostic near-infrared spectroscopy device (OxyPrem) (no clinical decisions based on oxygenation levels)

Study type: Interventional

Funder types: Other

Identifiers

NCT04860401

PB_2016-00395

Details and patient eligibility

About

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.

Enrollment: 117 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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117 participants in 1 patient group

precision and accuracy study

Experimental group

Description:

precision and accuracy of Oxyprem are studied

Treatment:

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