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Mitochondrial Oxygen Measurement Variability in Critically Ill Patients (INOX Variability Study)

NCT04626661 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 33

Last updated 2024-05-07

No results posted yet for this study

Summary

To determine the between- and within-subject variability of the mitochondrial oxygenation measurement with the COMET device over time in healthy subjects and in hemodynamically stable subjects admitted to the intensive care unit.

Conditions

  • Mitochondrial Oxygenation Measurement
  • Measurement Error
  • Healthy

Interventions

DEVICE

COMET measurement system

Photonics Healthcare B.V. has developed an innovative non-invasive bedside monitoring system to measure Cellular Oxygen METabolism (the COMET).The COMET's non-invasive cutaneous mitoPO2 measurements rely on the protoporphyrin IX-triple state lifetime technique (PpIX-TSLT). This technique measures oxygen by oxygen-dependent quenching of delayed fluorescence lifetime of 5-aminolevulinic acid-induced mitochondrial PpIX (protoporphyrin IX). PpIX is the final precursor of haem in the haem biosynthesis pathway and is synthetized in the mitochondria. Administration of exogenous 5-aminolevulinic acid enhances PpIX to detectable levels and enhances mitochondrial origin of the delayed fluorescence signal. Measurements are based on the detection of time of extinction of red light emitted by the tissue following excitation with green light. The technique has been tested and calibrated for use in isolated organs and in vivo.

Sponsors & Collaborators

  • Leiden University Medical Center

    collaborator OTHER

  • Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research

    lead OTHER

Principal Investigators

  • J. G. van der Bom, PhD, MD · Leiden University Medical Center

  • M. S. Arbous, PhD,MD · Leiden University Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2023-03-01
Completion
2023-05-17

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04626661 on ClinicalTrials.gov