Conditions

Healthy Measurement Error Mitochondrial Oxygenation Measurement

Outcome Measures

Primary Outcomes (1)

Within-subject variability of mitochondrial oxygenation measurements over a period of 24 hours after ALA-induction
To describe the between- and within-subject variability (assessed by standard deviation) of mitoPO2 measurements over a period of 24 hours after ALA-induction in healthy volunteers and in neurosurgical patients
24 hours

Secondary Outcomes (2)

Between- and within-subject variability between 3 hour offset 5-aminolevulinic acid-patches
24 hour
Safety of mitochondrial oxygenation measurements
48 hours

Study Arms (2)

Health volunteers

The study population will consist, initially, of healthy volunteers. This group was chosen to perform measurements on, to eliminate the effect of critical illness and interventions on the critically ill patients and to better explore the effect of time-since-application of the 5-aminolevulinic acid-patches.

Device: COMET measurement system

Patients admitted to the ICU after neurosurgery

This study population will consist of patients undergoing elective neurosurgery with planned postoperative recovery of at least 24 hours in the intensive care unit or medium care unit. Leiden University Medical Center is a neurosurgical center in which a wide variety of surgeries including tumor resection in the posterior cranial fossa (including vestibular schwannoma) are performed. Clinical experience has shown that this cohort of patients are in general, hemodynamically the most stable patients and receive the least amount of interventions compared to other cohorts of patients in the intensive care unit and medium care unit. For these reasons, the cohort of elective neurosurgical patients would be ideal to investigate the reason of the increased between- and within-subject variability of mitochondrial oxygen tension in the intensive care unit and medium care unit setting.

Device: COMET measurement system

Interventions

COMET measurement systemDevice

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.

Health volunteersPatients admitted to the ICU after neurosurgery

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

The study population will consist, initially, of healthy volunteers. This group was chosen to perform measurements on, to eliminate the effect of critical illness and interventions on the ICU and to better explore the effect of time-since-application of the ALA-patches. Neurosurgical ICU/MC patients will subsequently be included to further explore the effect of critical illness (ICU admission). Since this cohort of patients receives minimal interventions, they are ideal to limit potential affecters on the between- and therefore also the within-subject variability.

You may qualify if:

Sponsors & Collaborators

Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
Otherlead
Leiden University Medical Center
Othercollaborator

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

Related Publications (1)

Baysan M, Broere M, Wille ME, Bergsma JE, Mik EG, Juffermans NP, Tsonaka R, van der Bom JG, Arbous SM. Description of mitochondrial oxygen tension and its variability in healthy volunteers. PLoS One. 2024 Jun 3;19(6):e0300602. doi: 10.1371/journal.pone.0300602. eCollection 2024.
PMID: 38829894DERIVED

Study Officials

J. G. van der Bom, PhD, MD
Leiden University Medical Center
PRINCIPAL INVESTIGATOR
M. S. Arbous, PhD,MD
Leiden University Medical Center
PRINCIPAL INVESTIGATOR

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Health volunteers

Patients admitted to the ICU after neurosurgery

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Health volunteers

Patients admitted to the ICU after neurosurgery

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations