Intraoperative Optimisation of Tissue Oxygenation

Higk Risk Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01342900
• Other study ID #: IOTO-001
• Status: Completed
• Phase: N/A
• First received: April 21, 2011
• Last updated: February 20, 2013
• Start date: May 2011
• Est. completion date: December 2012

Study information

• Verified date: February 2013
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Higk Risk Surgery
• Postoperative Complications

Intervention

Device:
• connected to the InSpectra Monitor

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of perioperative complications	organ dysfunction, SOFA score, troponin T, creatinin, CRP	during operation	Yes