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Intraoperative Optimisation of Tissue Oxygenation

Primary Purpose

Higk Risk Surgery

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

connected to the InSpectra Monitor

About this trial

This is an interventional prevention trial for Higk Risk Surgery focused on measuring tissue oxygenation, higk risk surgery, high risk patient, postoperative complications

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

University Medical Center Groningen

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

standard care

Treatment group,

Arm 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

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

Outcomes

Primary Outcome Measures

incidence of perioperative complications

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01342900

First Posted

April 21, 2011

Last Updated

February 20, 2013

Sponsor

University Medical Center Groningen

1. Study Identification

Unique Protocol Identification Number

NCT01342900

Brief Title

Intraoperative Optimisation of Tissue Oxygenation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Medical Center Groningen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Higk Risk Surgery

Keywords

tissue oxygenation, higk risk surgery, high risk patient, postoperative complications

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

standard care

Arm Type

No Intervention

Arm 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

Arm Title

Treatment group,

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

connected to the InSpectra Monitor

Primary Outcome Measure Information:

Title

incidence of perioperative complications

Description

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

Time Frame

during operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas W.L. Scheeren, Prof.dr.

Organizational Affiliation

University Medical Center Groningen

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Medical Center Groningen

City

Groningen

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

25580087

Citation

van Beest PA, Vos JJ, Poterman M, Kalmar AF, Scheeren TW. Tissue oxygenation as a target for goal-directed therapy in high-risk surgery: a pilot study. BMC Anesthesiol. 2014 Dec 16;14:122. doi: 10.1186/1471-2253-14-122. eCollection 2014.

Results Reference

derived

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Intraoperative Optimisation of Tissue Oxygenation

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