Tissue Oxygenation During Heart Surgery

NCT01347827 | Completed

• 1 other identifier: TO-CABG
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to determine if off-pump CABG surgery is associated with better cerebral tissue oxygenation when compared with on-pump CABG. In addition, the investigators would like to compare the results of two different monitors of brain tissue oxygenation with each other, and assess the correlation between brain tissue oxygenation and oxygenation measurements in renal and muscular tissue, as well as with conventional hemodynamic and metabolic variables, such as central venous oxygen saturation (ScvO2). Finally, the investigators aim to determine if duration and extent of cerebral oxygen desaturation predict outcome variables such as postoperative cognitive performance.

Conditions

Coronary Artery Bypass Grafting

Keywords

Coronary artery bypass surgery; Oximetry; Brain metabolism

Outcome Measures

Primary Outcomes (1)

• incidence of significant brain tissue oxygen desaturation, defined as AUC40 > 600 %.sec (a function of both duration (in seconds) and severity (saturation < 40%) of desaturation).

  3 months

Secondary Outcomes (1)

• Oxygenation measurements: Peripheral muscle StO2, cerebral and renal StO2, ScvO2, SaO2, arteriovenous oxygen difference, pO2 Acid-base status: pH, pCO2, HCO3-, ABE, lactate

  3 months

Study Arms (2)

on pump

Coronary artery bypass grafting (CABG)with with cardiopulmonary bypass

Device: measurements of brain tissue oxygenation

off pump

off-pump CABG surgery

Device: measurements of brain tissue oxygenation

Interventions

measurements of brain tissue oxygenation DEVICE

different monitors((the Hutchinson InSpectra™ StO2 Tissue Oxygenation Monitor) and in cerebral (ForeSight® Cerebral Oximeter and the Somanetics INVOS® Cerebral Oximeter ) and renal tissue (the Somanetics INVOS® Cerebral Oximeter)of brain tissue oxygenation with each other, and assess the correlation between brain tissue oxygenation and oxygenation measurements in renal and muscular tissue, as well as with conventional hemodynamic and metabolic variables, such as central venous oxygen saturation

on pump

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

60 consecutive adult patients scheduled for elective CABG surgery will be randomized to have the surgery performed either on-pump (n=30) or off-pump CABG (n=30).

You may qualify if:

• Age ≥18 years
• Informed patient consent
• Coronary artery disease suitable for both on-pump and off-pump CABG surgery.

You may not qualify if:

• History of head trauma or stroke causing significant active neurologic disease
• History of neurosurgery
• Severe or symptomatic carotid artery disease
• Requirement for valve surgery in addition to CABG
• Pre-existing acute or chronic renal dysfunction
• Urgent or emergency surgery
• Difficulty with cognitive testing: impaired hearing or eyesight, poor Dutch language comprehension, disability impairing the usage of the hand or arm.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, Netherlands

Location

Related Publications (1)

• de Keijzer IN, Poterman M, Absalom AR, Vos JJ, Mariani MA, Scheeren TWL. Comparison of renal region, cerebral and peripheral oxygenation for predicting postoperative renal impairment after CABG. J Clin Monit Comput. 2022 Jun;36(3):735-743. doi: 10.1007/s10877-021-00701-4. Epub 2021 Apr 20.

  PMID: 33876337 DERIVED

Study Officials

• Thomas W.L. Scheeren, Prof.dr

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2011
• First Posted: May 4, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

NL (1)