CHECK-NIRS2D-Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-40
SponsorHeinrich-Heine University, Duesseldorf

About this trial

The study investigates how external, physiological, and behavioral factors influence the measurement of regional tissue oxygenation using two-dimensional near-infrared spectroscopy (NIRS) imaging in healthy volunteers. It aims to improve the standardization and reliability of this non-invasive method for assessing microvascular perfusion and tissue oxygenation.

The study also examines the effects of temporary vascular occlusion, ambient temperature, physical activity, caffeine consumption, and nicotine consumption on NIRS-based tissue oxygenation measurements. The findings are intended to establish a standardized measurement protocol for future clinical research and the assessment of microvascular perfusion in critically ill patients.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy volunteers aged 20-40 years

Written informed consent

Ability to understand and comply with the study procedures

Disqualifiers

Age below 20 years or above 40 years

Cardiovascular disease or other relevant medical conditions

current medication, where relevant to the study procedures

contraindication to or inability to undergo the planned examinations

Trial population

healthy volunteers

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

20 Participants
are grouped into 2 trial groups
Group A: Intervention
Group B: Control Group

Trial outcomes

Primary outcomes

1

microvascular tissue oxygenation

StO₂, expressed as a percentage

Time frame
within 20 Minutes of ischemia/reprefusion protocol measurement

Secondary outcomes

1

Retinal funduscopy parameters

measured by NIRS

Time frame
within 20 Minutes of ischemia/reprefusion protocol measurement

Other outcomes

Sponsors and contacts

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