Skip to content

Anaesthetic management guided by cellular oxygen metabolism measurements

Anaesthetic management guided by cellular oxygen metabolism measurements

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29588
Enrollment
98
Registered
2021-05-10
Start date
2021-08-02
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

Adult patients undergoing elective open or laparoscopic abdominal surgery.

Interventions

Standard anaesthetic management guided by mitoPO2 monitoring.

Sponsors

Amsterdam University Medical Centres, Location AMC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Patients are at least 18 years old • Patients undergo elective open or laparoscopic abdominal surgery with an expected minimal total incision size of 5 cm • Patients are able and willing to give written informed consent

Exclusion criteria

Exclusion criteria: • Known photodermatoses of varying pathology and frequency • Mitochondrial disease • Porphyria • Skin lesions on the upper arm which impede measurements • Hypersensitivity to the active substance or the 5-ALA medicated plaster material • Emergency surgery • Reoperation for complications from recent surgery (within last three months) • Participation in another study with interference with this study • Pregnancy or breastfeeding

Design outcomes

Primary

MeasureTime frame
Mean mitoPO2 during abdominal surgery over time

Secondary

MeasureTime frame
Secondary outcomes are the number, type and the respective effect of interventions that results in an increase of mitoPO2 after notification in which mitoPO2 aids decision making on anaesthetic management, the proportion of these incidences that were associated with a change in mitoPO2 and the proportion of patients this occurs in, the average cumulative duration of mitoPO2 below individual baseline value, the association of mitoPO2 with conventional hemodynamic monitoring measures and the SSI incidence after 30 days follow-up.

Contacts

Public ContactRick Hulskes

Amsterdam UMC, location AMC

r.h.hulskes@amsterdamumc.nl0205669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)