Skip to main content
MedPathMedPath Home
Clinical Trials/NCT01342900
NCT01342900
Completed
Not Applicable

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

University Medical Center Groningen1 site in 1 country48 target enrollmentMay 2011
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsHigk Risk Surgery

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Higk Risk Surgery
Sponsor
University Medical Center Groningen
Enrollment
48
Locations
1
Primary Endpoint
incidence of perioperative complications
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2011
End Date
December 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Prof.dr.T.W.L.Scheeren

Prof.dr.

University Medical Center Groningen

Eligibility Criteria

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

Outcomes

Primary Outcomes

incidence of perioperative complications

Time Frame: during operation

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

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
Measurement of Cardiac Index Using an Implanted Central Venous Access Port in Patients Scheduled for Oncologic High-risk SurgeryOncologic High-risk Surgery
NCT02063009Gustave Roussy, Cancer Campus, Grand Paris33
Completed
Not Applicable
Transpulmonary Thermodilution Using an Implented Central Venous Access PortMedical Oncology
NCT02357953Gustave Roussy, Cancer Campus, Grand Paris20
Terminated
Not Applicable
The Use of Tissue Oxygen Monitoring in Critically Injured PatientsTraumatic Brain InjuryHemorrhagic ShockTrauma
NCT00328341University of California, San Francisco67
Withdrawn
Not Applicable
FiO2 and Outcomes After Cardiac Surgery With Cardiopulmonary BypassPatients Undergoing Cardiac Surgery Using Cardiopulmonary Bypass
NCT03939832Seoul National University Hospital
Completed
Not Applicable
FiO2 and Outcomes After OPCAB (the CARROT Trial)Coronary Artery Disease
NCT03945565Seoul National University Hospital414