Intraoperative Optimisation of Tissue Oxygenation

University Medical Center Groningen48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Higk Risk Surgery

Interventions

connected to the InSpectra MonitorDEVICE

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

Outcomes

Primary Outcomes

incidence of perioperative complications

organ dysfunction, SOFA score, troponin T, creatinin, CRP

Time frame: during operation

Data from ClinicalTrials.gov

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