Anaesthetic management guided by cellular oxygen metabolism measurements

Completed

• Conditions: surgical site infection; surgical wound infection; 10004018; 10017998

• Registration Number: NL-OMON51147
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 98

Inclusion Criteria

Patients are at least 18 years old
Patients undergo elective open or laparoscopic abdominal surgery
Patients are able and willing to give written informed consent

Exclusion Criteria

Known photodermatoses of varying pathology and frequency
Mitochondrial disease
Porphyria
Hypersensitivity to the active substance or to the 5-ALA medicated plaster
material
Emergency surgery
Re-operation for complications from recent surgery (within last three months)
Participation in another study with interference with this study
Pregnancy or breast-feeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the mean mitoPO2 over time. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are the number of incidences that mitoPO2 aids<br /><br>decision-making on anaesthetic management, the proportion of these incidences<br /><br>that were associated with a change in mitoPO2 or a change in mitoPO2 slope and<br /><br>the proportion of patients this occurs in, the type of interventions used to<br /><br>improve mitoPO2 and their respective effect, the average cumulative duration of<br /><br>mitoPO2 below individual baseline value, the association of mitoPO2 with<br /><br>conventional hemodynamic monitoring measures and the SSI incidence after 30<br /><br>days follow-up.</p><br>