Mitochondrial oxygen measurement variability in critically ill patients: Validation of the COMET measurement system

Completed

• Conditions: brain surgery; neurosurgery; 10029305

• Registration Number: NL-OMON54934
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 34

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

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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Between- and within-subject variability (assessed by standard deviation) of<br /><br>mitoPO2 measurements over a period of 24 hours after ALA-induction.<br /><br>- Initially in healthy volunteers<br /><br>- Followed by neurosurgical patients admitted postoperatively to the ICU or MC,<br /><br>PACU or other hospital ward. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>- Description of the differences in the between- and within-subject variability<br /><br>between 3 hour offset ALA-patches.<br /><br>- Description of between- and within-subject variability in healthy volunteers<br /><br>and neurosurgical patients in relation to the between- and within-subject<br /><br>variability of the INOX ICU-2 pilot study (NL59512.058.16)<br /><br>- Report on adverse and serious adverse events of the mitoPO2 measurements.</p><br>