The primary goal of this study is to get insight in the functionality of the COMET in the clinic. Secondly, since this will be the first continues mitochondrial oxygenation measurement in patients undergoing surgery, we want to obtain information…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
basale fysiologie mitochondriele functie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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?
Background summary
Mitochondrial function seems to play a key role in the development op sepsis,
septic shock and optimization of erythrocyte transfusion trigger. So far our
knowledge about mitochondrial function, is mainly obtained from ex vivo
measurements on isolated mitochondria, mainly derived from animal biopsies. The
development of the Protoporphyrin IX - Triplet State lifetime Technique (PpIX
-TSLT), which is incorporated in the recently devolved COMET, makes continues,
non- invasive monitoring of mitochondrial function possible. This technique is
tested on healthy volunteers. The next step before implementation of this
technique is to test in the clinic. The goal of this this observational
clinical study is, to find out if the COMET is clinically applicable and
secondly to get insight in the function of the mitochondria under different
circumstances.
Study objective
The primary goal of this study is to get insight in the functionality of the
COMET in the clinic. Secondly, since this will be the first continues
mitochondrial oxygenation measurement in patients undergoing surgery, we want
to obtain information about the mitochondrial oxygenation (mitoPO2) and oxygen
consumption (mitoVO2) during vasodilatation (induction of anesthesia) and
vasoconstriction (during vasopressor therapy).
Study design
single centre observational study
Study burden and risks
There are no direct benefits for the subjects enrolled in the study.
Administration of ALA cream is safe. The risk of phototoxity after PpIX
induction is considered low, because the COMET uses short-pulsed excitation and
very low total light dosage. To limit the effects of phototoxity, the sight of
the measurement will be coved with a plaster during 24 hours after the
measurements. In the study with healthy volunteers. only local, transient skin
irritations were seen, erythema, edema and hyper pigmentation
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL51937.078.15 |