Road to recovery: a study protocol quantifying neurological outcome in cardiac surgery patients and the role of cerebral oximetry

BMJ Open. 2019 Dec 3;9(12):e032935. doi: 10.1136/bmjopen-2019-032935.

Abstract

Introduction: Patients undergoing cardiac surgery may experience both short-term and long-term postoperative neurological problems. However, the underlying cause of this impairment is unclear. Regional cerebral oxygen saturation (rSO2) levels may play a role in the development of acute dysfunction, known as postoperative delirium, in addition to longer term outcomes after cardiac surgery. Yet the degree of impairment has been difficult to define, partly due to subjective methods of assessments. This study aims to fill this knowledge gap by determining the relationship between rSO2, postoperative delirium and long-term neurological outcome after cardiac surgery using quantitative robotic technology.

Methods and analysis: 95 patients scheduled for elective cardiac surgery will be recruited for this single-centre prospective observational study. Patients will be assessed before as well as 3 and 12 months after their surgery using the Kinarm End-Point Lab and standardised tasks. Intraoperatively, rSO2 and other haemodynamic data will be collected for the duration of the procedure. Following their operation, patients will also be screened daily for delirium during their hospital stay.

Ethics and dissemination: This study has been approved by the Health Sciences Research Ethics Board at Queen's University (DMED-1672-14). The results of this study will be published in a peer-review journal and presented at international and/or national conferences as poster or oral presentations. Participants wishing to know the results of this study will be contacted directly on data publication.

Trial registration number: NCT04081649.

Keywords: cardiac surgery; delirium; neurological assessment; post-operative cognitive dysfunction; robotic technology.

Publication types

  • Clinical Trial Protocol
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Brain / blood supply*
  • Cardiac Surgical Procedures / adverse effects*
  • Cardiac Surgical Procedures / methods
  • Delirium* / diagnosis
  • Delirium* / etiology
  • Elective Surgical Procedures / adverse effects
  • Female
  • Humans
  • Intraoperative Neurophysiological Monitoring / methods*
  • Male
  • Middle Aged
  • Neurologic Examination / methods
  • Observational Studies as Topic
  • Outcome Assessment, Health Care
  • Oximetry / methods*
  • Oxygen Consumption*
  • Postoperative Cognitive Complications / diagnosis*
  • Regional Blood Flow*

Associated data

  • ClinicalTrials.gov/NCT04081649