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Intraoperative Optimisation of Tissue Oxygenation

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ClinicalTrials.gov Identifier: NCT01342900
Recruitment Status : Completed
First Posted : April 27, 2011
Last Update Posted : February 21, 2013
Sponsor:
Information provided by (Responsible Party):
Prof.dr.T.W.L.Scheeren, University Medical Center Groningen

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.


Condition or disease Intervention/treatment Phase
Higk Risk Surgery Device: connected to the InSpectra Monitor Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Intraoperative Monitoring and Optimisation of Tissue Oxygenation In High-Risk Surgical Patients for Reduction of Postoperative Complications: a Pilot Study
Study Start Date : May 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: standard care
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
Active Comparator: Treatment group,
The data given by the monitor will be available for the Investigator and used to apply the optimization protocol
Device: connected to the InSpectra Monitor



Primary Outcome Measures :
  1. incidence of perioperative complications [ Time Frame: during operation ]
    organ dysfunction, SOFA score, troponin T, creatinin, CRP



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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01342900


Locations
Netherlands
University Medical Center Groningen
Groningen, Netherlands
Sponsors and Collaborators
University Medical Center Groningen
Investigators
Principal Investigator: Thomas W.L. Scheeren, Prof.dr. University Medical Center Groningen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof.dr.T.W.L.Scheeren, Prof.dr., University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT01342900     History of Changes
Other Study ID Numbers: IOTO-001
First Posted: April 27, 2011    Key Record Dates
Last Update Posted: February 21, 2013
Last Verified: February 2013

Keywords provided by Prof.dr.T.W.L.Scheeren, University Medical Center Groningen:
tissue oxygenation
higk risk surgery
high risk patient
postoperative complications

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes