CHECK-NIRS2D-Study

NCT07854431 | Recruiting

• 1 other identifier: CHECK-NIRS2D-Study
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

NIRS; Tissue Oxygenation; Microvascular Perfusion; Vascular Occlusion Test; Ischemia-reperfusion; Healty Volunteers; Physiological and Behavioral Factors; Temperature; Caffeine; Nicotine; Microcirculation; Protocol Standardization

Outcome Measures

Primary Outcomes (1)

• microvascular tissue oxygenation

  StO₂, expressed as a percentage

  within 20 Minutes of ischemia/reprefusion protocol measurement

Secondary Outcomes (1)

• Retinal funduscopy parameters

  within 20 Minutes of ischemia/reprefusion protocol measurement

Study Arms (2)

Intervention

predefined measurements

Control Group

Standardized 2D-NIRS imaging at rest under predefined reference conditions, including the protocol-defined VOT.

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

healthy volunteers

You may qualify if:

• Healthy volunteers aged 20-40 years
• Written informed consent
• Ability to understand and comply with the study procedures

You may not qualify if:

• 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
• Any condition that may interfere with the study procedures or outcome measurements

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

University Hospital Duesseldorf

Düsseldorf, 40225, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

prospectively defined blood sampling protocol

Study Officials

• Malte Kelm, MD

  Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf

  STUDY CHAIR

Central Study Contacts

Patricia Wischmann, MD

CONTACT

+49211 18000; patricia.wischmann@med.uni-duesseldorf.de

Stefan Hof, MD

CONTACT

Stefan.hof@med.uni-duesseldorf.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start: July 28, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)