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Intraoperative Optimisation of Tissue Oxygenation

Intraoperative Monitoring and Optimisation of Tissue Oxygenation In High-Risk Surgical Patients for Reduction of Postoperative Complications: a Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01342900
Enrollment
48
Registered
2011-04-27
Start date
2011-05-31
Completion date
2012-12-31
Last updated
2013-02-21

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

Conditions

Higk Risk Surgery

Keywords

tissue oxygenation, higk risk surgery, high risk patient, postoperative complications

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.

Interventions

DEVICEconnected to the InSpectra Monitor

Sponsors

University Medical Center Groningen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
incidence of perioperative complicationsduring operationorgan dysfunction, SOFA score, troponin T, creatinin, CRP

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026