Intraoperative Optimisation of Tissue Oxygenation
Not Applicable
Completed
- Conditions
- Higk Risk Surgery
- Interventions
- Device: connected to the InSpectra Monitor
- Registration Number
- NCT01342900
- Lead Sponsor
- University Medical Center Groningen
- Brief Summary
Monitoring and optimizing tissue oxygenation (StO2) in high-risk surgery and/or high-risk surgical patients may decrease the risk of postoperative complications.
Tissue hypoxia occurs frequently during high-risk surgery in high-risk patients. The investigators want to see if an algorithm aimed at optimizing intraoperative tissue oxygenation reduces perioperative complications as well as length of stay in the intensive care unit (ICU LOS), 28-day mortality, and the duration of mechanical ventilation in these patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
. Major elective surgery
- Aged over 65 years with moderate functional limitation of one or more organ systems
- ASA classification III or IV, i.e. severe cardiac, vascular, respiratory or metabolic illness resulting in severe functional limitation
- Routine use of arterial and central venous lines
- Planned postoperative stay on ICU or PACU
Exclusion Criteria
- Refusal of consent
- acute myocardial ischemia prior to enrolment
- patients receiving palliative treatment only
- disseminated malignancy
- patients unlikely to survive more than 6 hours
- emergency surgery
- transplantations
- neurosurgical patients
- patients undergoing extensive liver surgery requiring low CVP management
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment group, connected to the InSpectra Monitor The data given by the monitor will be available for the Investigator and used to apply the optimization protocol
- Primary Outcome Measures
Name Time Method incidence of perioperative complications during operation organ dysfunction, SOFA score, troponin T, creatinin, CRP
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Medical Center Groningen
🇳🇱Groningen, Netherlands