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Clinical Trials/NCT02532530
NCT02532530CompletedNot Applicable

Peri-operative Monitoring of Regional Cerebral Oxygen Saturation and Onset of Delirium in Cardiac Surgery Patients

Hasselt University1 site in 1 country103 target enrollmentStarted: June 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
103
Locations
1
Primary Endpoint
Association between changes in cerebral oxygen saturation and postoperative delirium (preoperative)

Study Overview

Brief Summary

Delirium is an acute brain syndrome characterized by a disturbance in consciousness accompanied by periods of inattention and changes in cognition. Memory impairment, irrelevant speech and disorientation are commonly observed signs and symptoms. Episodes of delirium have been associated with a prolonged hospital stay, functional and cognitive dysfunction and even an increased mortality. Delirium is a common complication in the postoperative setting where the incidence increases with the risk of surgery. The estimated incidence of postoperative delirium after cardiovascular surgery is remarkable, ranging from 31% up to 51%. Diverse preoperative risk factors have been documented for patients undergoing cardiac surgery: age, pre-existing cognitive dysfunction, a history of alcohol abuse and the severity of illness at admission.

An early diagnosis of postoperative delirium is of great importance to prevent long-term cognitive impairment. For this purpose, a highly specific diagnostic monitoring tool should be implemented during perioperative cardiac surgery care. Near infrared spectroscopy (NIRS) provides information on brain oxygenation by quantifying the regional cerebral oxygen saturation (SctO2) at the microvascular level. Recently, two studies showed that preoperative cerebral tissue oxygenation was lower in the cohort of patients that developed delirium postoperatively. Nevertheless, these studies did not investigate whether the onset of postoperative delirium coincided with a change of postoperative SctO2. A relationship between delirium and reduced cerebral blood flow has already been suggested. As such, the occurrence of a postoperative decrease of SctO2 might have been overlooked thus far. Hence, Investigators want to conduct a prospective, interventional study to determine the relationship between postoperative SctO2 and the onset of delirium after cardiac surgery.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
70 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Adult patients (age ≥ 70 years) undergoing elective on-pump cardiac surgery (i.e. valve replacement with or without Coronary artery bypass graft surgery (CABG))
  • •Surgery has to be performed under normothermic conditions
  • •Ability to perform the confusion assessment method for the intensive care unit (CAM-ICU)
  • •Patients willing to provide written informed consent

Exclusion Criteria

  • •Age < 70 years
  • •Off-pump cardiac surgery
  • •Surgery performed under hypothermic conditions
  • •Duration before extubation > 36 hours
  • •Patients with insufficient knowledge of the Dutch language
  • •Patients using antipsychotics
  • •Patients with a known history of alcohol abuse (consuming two or more units a day)

Arms & Interventions

Study group

Other

Adult patients (age ≥ 70 years) undergoing elective on-pump cardiac surgery (i.e. valve replacement with or without 'Coronary Artery Bypass Graft' (CABG) surgery)

Intervention: Near-Infrared Spectroscopy (NIRS) (Device)

Outcomes

Primary Outcomes

Association between changes in cerebral oxygen saturation and postoperative delirium (preoperative)

Time Frame: pre, intra and postoperative measurement of cerebral oxygen saturation (three days)

The primary objective is to investigate if the development of delirium after cardiac surgery coincides with changes of the cerebral oxygen saturation.

Secondary Outcomes

  • Cerebral autoregulation performance using a COX index(Intraoperative measurement)

Investigators

Sponsor
Hasselt University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

prof. dr. Frank Jans

prof. dr.

Hasselt University

Study Sites (1)

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