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OpenTrials
Completed

NCT Number: NCT01342900

Intraoperative Optimisation of Tissue Oxygenation

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.

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Key information

Conditions

Higk Risk Surgery Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

connected to the InSpectra Monitor

Device

Primary outcomes

  1. incidence of perioperative complications

    Time frame: during operation

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

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 27, 2011
Registry last updated
Feb 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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