Intraoperative Optimisation of Tissue Oxygenation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof.dr.T.W.L.Scheeren, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01342900
First received: April 21, 2011
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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 Intervention
Higk Risk Surgery
Device: connected to the InSpectra Monitor

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • incidence of perioperative complications [ Time Frame: during operation ] [ Designated as safety issue: Yes ]
    organ dysfunction, SOFA score, troponin T, creatinin, CRP


Enrollment: 48
Study Start Date: May 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01342900

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

No publications provided

Responsible Party: Prof.dr.T.W.L.Scheeren, Prof.dr., University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01342900     History of Changes
Other Study ID Numbers: IOTO-001
Study First Received: April 21, 2011
Last Updated: February 20, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by University Medical Centre Groningen:
tissue oxygenation
higk risk surgery
high risk patient
postoperative complications

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014