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*Non-invasive monitoring of mitochondrial oxygen consumption and oxygenation (COMET): observational clinical study.*

*Non-invasive monitoring of mitochondrial oxygen consumption and oxygenation (COMET): observational clinical study.* - Clinical application COMET

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON41866
Enrollment
45
Registered
2016-01-08
Start date
2015-07-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

basale fysiologie mitochondriele functie oxygen consumption and oxygenation mitochondrien

Interventions

Anesthesia
Mitochondrial
Oxygen

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The mean and standard deviation of the mitoPO2 and mitoVO2 in mmHg. For the mitoVO2 and the mitoP50 measurements, the local mitochondrial oxygen supply will be blocked by pressure on the skin. Primary Objective: - Is the COMET clinically applicable? Is there the need for any practical or technical adjustments before implementing the technique on the intensive care? - Is it possible to measure the mitoPO2, mitoVO2 and the mitoP50 during surgery on ASA1-2 patients. Are these results replicable and are these results comparable with the data from healthy volunteers?

Secondary

MeasureTime frame
Secondary Objectives: - What will happen with the signal during induction of anaesthesia, what will generate vasodilatation? And in continuation what will happen with the signal when a vasopressor is given? In order to investigate this in a strictly observational study, our study population will be ASA 1-2 patients for intracranial tumour surgery; relatively few comorbidities, admitted to the ward prior to surgery, and during surgery arterial pressure monitoring is standard of care, as well as the administration of a vasopressor in order to achieve haemostasis. - Is the signal influenced by parameters other than seen in the animal models/ healthy volunteers? - For the resection of intracerebral gliomas, ALA (gliolan) is used systemically for fluorescence-guided resection. Is it possible to measure mitoPO2 and mitoVO2 with systemically applied ALA, for future research?

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)