Impact of Cerebral Monitoring on Neurologic Outcome in Cardiac Surgery

NCT02006212 | Completed

• 1 other identifier: SARB 23th November 2013
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

Neurologic complications after cardiac surgery range over a wide spectrum including postoperative delirium (PD), postoperative cognitive dysfunction (POCD) and cerebrovascular accidents (CVA). The incidence of these neurologic events varies depending on the type of surgery and the population studied. The incidence of PD and/or POCD is further influenced by the type of the neurologic tests used. Moreover, the timing of these tests seems to influence the results. Intraoperative cerebral monitoring is gaining importance in the anesthesia field. Recent findings have pointed out that cerebral hypoperfusion on one hand and deep levels of anesthesia on the other hand are major sources of adverse neurological outcomes, both of which can be detected with different non-invasive cerebral monitors.The present investigators are currently using the NeuroSENSE®, a processed electroencephalogram (pEEG) monitor together with cerebral near-infrared spectroscopy (NIRS) on a daily basis in every cardiac patient. This large, prospective, observational study will investigate whether the short- and mid-term neurologic outcome of adult patients undergoing cardiac surgery are in line with observations made on the basis of the pEEG monitor NeuroSENSE® and cerebral NIRS.

Conditions

Cardiac Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• The incidence of neurological complications is measured. Area Under the Curve (AUC) of burst suppression of each hemisphere on one hand and AUC of 25% drop of oximetry values as compared to the pre induction values on the other is measured.

  Intraoperatively

Secondary Outcomes (2)

• The concomitant existence of AUC of burst suppression with AUC of 25% drop of oximetry values are measured.

  Intraoperatively

• Agreement between the cerebral NIRS and the NeuroSENSE® monitor in terms of detecting BSR and Oximetry desaturation is measured.

  Intraoperatively

Other Outcomes (1)

• pEEG asymmetry together with burst suppressions are recorded.

  Intraoperatively

Study Arms (1)

cadiac surgical patient; One arm

OTHER

All patients undergoing first or redo cardiac surgery with or without cardiopulmonary bypass necessitating general and/or local anesthesia. If they present any EEG abnormality intraoperatively an immediate cerebral CT scan will be performed and the necessary measures will be taken to reduce the neurologic damage.

Procedure: If any intraoperative EEG abnormality and/or asymmetry is detected a cerebral CT scan will be performed in the immediate postoperative period

Interventions

If any intraoperative EEG abnormality and/or asymmetry is detected a cerebral CT scan will be performed in the immediate postoperative period PROCEDURE

cadiac surgical patient; One arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients undergoing first or redo cardiac surgery with or without cardiopulmonary bypass and with or without general anesthesia

You may not qualify if:

• patients sedated and/or intubated before the procedure
• patients who cannot complete the French version of Mini Mental State Examination
• patients who cannot be contacted at 6 months postoperatively

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

Related Publications (1)

• Momeni M, Baele P, Jacquet LM, Peeters A, Noirhomme P, Rubay J, Docquier MA. Detection by NeuroSENSE Cerebral Monitor of Two Major Neurologic Events During Cardiac Surgery. J Cardiothorac Vasc Anesth. 2015 Aug;29(4):1013-5. doi: 10.1053/j.jvca.2013.08.012. Epub 2013 Nov 28. No abstract available.

  PMID: 24290745 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD; PhD

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 10, 2013
• Study Start: January 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: April 25, 2017

Record last verified: 2016-01

Locations

BE (1)