The primary objective of this pilot trial is to evaluate if adding mitoPO2 monitoring to standard anaesthetic management enables tissue oxygenation optimisation.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the mean mitoPO2 over time.
Secondary outcome
Secondary outcomes are the number of incidences that mitoPO2 aids
decision-making on anaesthetic management, the proportion of these incidences
that were associated with a change in mitoPO2 or a change in mitoPO2 slope and
the proportion of patients this occurs in, the type of interventions used to
improve mitoPO2 and their respective effect, 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.
Background summary
Surgical site infection (SSI) is one of the most common healthcare-associated
infections (HAIs) and a significant cause of morbidity and mortality, prolonged
hospital stays and healthcare costs. Perioperative low tissue oxygen tension
(tPO2) is associated with a high risk of SSI. Continuous monitoring of oxygen
delivery (DO2) with a non-invasive method of measuring mitochondrial
oxygenation tension (mitoPO2) using the COMET (Cellular Oxygen METabolism)
monitor may benefit the intraoperative oxygenation on the tissue level,
potentially reducing the incidence of SSI.
Study objective
The primary objective of this pilot trial is to evaluate if adding mitoPO2
monitoring to standard anaesthetic management enables tissue oxygenation
optimisation.
Study design
Randomised controlled patient-blinded parallel-group multicentre pilot trial.
Intervention
Intraoperative monitoring and optimisation of DO2 using the COMET in addition
to standard anaesthetic management.
Study burden and risks
The subjects receive usual care and do not require deviation from standard
protocol, regardless of their allocation. The COMET*s intraoperative
non-invasive measurements are regarded as safe and do not result in any
increased risk. The 5-aminolevulinic acid (5-ALA) medicated plaster is widely
used in Actinic Keratosis (AK) treatment and is generally accepted. Patients
will be subjected to regular follow-up, which does not deviate from usual care.
Overall risks are considered negligible and the burden low.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL77186.018.21 |
| OMON | NL-OMON29588 |