Intraoperative Optimisation of Tissue Oxygenation

University Medical Center Groningen (UMCG)

Status: Completed

Conditions: Higk Risk Surgery

Treatments: Device: connected to the InSpectra Monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT01342900

IOTO-001

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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48 participants in 2 patient groups

standard care

No Intervention group

Description:

The data from the InSPectra Monitor in the Control group will be inaccessible for the Investigator since this is not a part of their daily medical practice

Treatment group,

Active Comparator group

Description:

The data given by the monitor will be available for the Investigator and used to apply the optimization protocol

Treatment:

Device: connected to the InSpectra Monitor