brain surgery neurosurgery
Conditions
Interventions
None listed
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients meeting all these criteria will be included in the study: • Age of patient is at least 18 years • Healthy participants, defined as the absence of active or chronic disease (applicable only to healthy volunteer group). • Patients are admitted to the intensive care unit, medium care, PACU or other hospital ward after neurosurgery (applicable only to neurosurgery group).
Exclusion criteria
Exclusion criteria: Patient meeting one of these criteria will be excluded from the study: • pregnant or breast feeding women since there is no adequate data from the use of ALA in pregnant or breast feeding women • patients with porphyria and/or known photodermatosis • patients with hypersensitivity to the active substance or to the plaster material of ALA • insufficient comprehensibility of the Dutch language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Between- and within-subject variability (assessed by standard deviation) of mitoPO2 measurements over a period of 24 hours after ALA-induction. - Initially in healthy volunteers - Followed by neurosurgical patients admitted postoperatively to the ICU or MC, PACU or other hospital ward. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: - Description of the differences in the between- and within-subject variability between 3 hour offset ALA-patches. - Description of between- and within-subject variability in healthy volunteers and neurosurgical patients in relation to the between- and within-subject variability of the INOX ICU-2 pilot study (NL59512.058.16) - Report on adverse and serious adverse events of the mitoPO2 measurements. | — |
Countries
Netherlands
Outcome results
None listed