Tissue Oxygenation During Heart Surgery

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.

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Key information

Conditions

Coronary Artery Bypass Grafting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

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

Primary outcomes

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).

Time frame: 3 months

Secondary outcomes

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

Time frame: 3 months
- To determine if oxygenation measurements obtained in peripheral (thenar) muscle, renal tissue and in cerebral tissue correlate with each other
- To determine if oxygenation measurements obtained in peripheral (thenar) muscle, renal tissue and in cerebral tissue correlate with conventional hemodynamic and metabolic variables such as central venous oxygen saturation (ScvO2).

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

Comparison of Cerebral Tissue Oxygen Desaturation in Patients Undergoing On-pump or Off-pump Coronary Artery Bypass Grafting

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: May 4, 2011
Registry last updated: Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed