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Tissue Oxygenation During Heart Surgery

U

University Medical Center Groningen (UMCG)

Status

Completed

Conditions

Coronary Artery Bypass Grafting

Treatments

Device: measurements of brain tissue oxygenation

Study type

Observational

Funder types

Other

Identifiers

NCT01347827
TO-CABG

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

on pump
Description:
Coronary artery bypass grafting (CABG)with with cardiopulmonary bypass
Treatment:
Device: measurements of brain tissue oxygenation
Device: measurements of brain tissue oxygenation
off pump
Description:
off-pump CABG surgery
Treatment:
Device: measurements of brain tissue oxygenation
Device: measurements of brain tissue oxygenation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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