*Non-invasive monitoring of mitochondrial oxygen consumption and oxygenation (COMET): observational clinical study.*
- Conditions
- basale fysiologie mitochondriele functieoxygen consumption and oxygenation mitochondrien
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 45
Inclusion Criteria
- Age 18-70 years
- Acceptable proficiency of the Dutch language
- ASA 1-2 patients, in order to limit the influence of co-morbidities on the mitochondrial function.
- Surgery for intracranial tumor;besides the inclusion of 40 patients for topical ALA application, we also will include 5 patients who receive ALA (gliolan) systemically for intracranial glioma resection, for further clinical research. In total 45 patients will be included.
Exclusion Criteria
- allergy 5-aminolevuline
- No time to place plaster 3h prior to surgery
-When there no indication for invasive intra-arterial blood pressure monitoring
-Presence of Mitochondrial disease
- pregnancy/ lactation
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The mean and standard deviation of the mitoPO2 and mitoVO2 in mmHg. For the<br /><br>mitoVO2 and the mitoP50 measurements, the local mitochondrial oxygen supply<br /><br>will be blocked by pressure on the skin.<br /><br>Primary Objective:<br /><br>- Is the COMET clinically applicable? Is there the need for any practical or<br /><br>technical adjustments before implementing the technique on the intensive care?<br /><br>- Is it possible to measure the mitoPO2, mitoVO2 and the mitoP50 during surgery<br /><br>on ASA1-2 patients. Are these results replicable and are these results<br /><br>comparable with the data from healthy volunteers?</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Objectives:<br /><br>- What will happen with the signal during induction of anaesthesia, what will<br /><br>generate vasodilatation? And in continuation what will happen with the signal<br /><br>when a vasopressor is given? In order to investigate this in a strictly<br /><br>observational study, our study population will be ASA 1-2 patients for<br /><br>intracranial tumour surgery; relatively few comorbidities, admitted to the ward<br /><br>prior to surgery, and during surgery arterial pressure monitoring is standard<br /><br>of care, as well as the administration of a vasopressor in order to achieve<br /><br>haemostasis.<br /><br>- Is the signal influenced by parameters other than seen in the animal models/<br /><br>healthy volunteers?<br /><br>- For the resection of intracerebral gliomas, ALA (gliolan) is used<br /><br>systemically for fluorescence-guided resection. Is it possible to measure<br /><br>mitoPO2 and mitoVO2 with systemically applied ALA, for future research?</p><br>