Neuromonitoring in Patients During Aortic Valve Replacement

NCT02697786 | Unknown Phase 3

• 1 other identifier: ARRS-RPROJ - J R- 2014- 191
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative brain damage and neuropsychological disorders have been observed in 30 - 80 % of patients after heart surgery with the use of cardiopulmonary bypass (CPB).They can persist up to a year after cardiac surgery and are associated with increased hospital mortality and prolonged intrahospital stay. Hypoperfusion,hyperthermia,atrial fibrillation,genetic predisposition and systemic inflammatory response associated with CPB have been identified as pathophysiological mechanisms.However, some authors consider cerebral embolisation to be the prevalent mechanism of intraoperative brain injury after cardiac surgery,as gaseous or solid cerebral emboli can cause ischemia, inflammation and edema,consequently causing cerebral infarctions usually resulting with stroke,coma,encephalopathy, delirium and cognitive decline. Additionally,they may impair cerebrovascular reactivity (CVR). Aortic valve replacement (AVR) preformed by full sternotomy is the standard approach in the treatment of aortic valve disease. Minimally invasive (MIS) aortic valve replacement has been shown to reduce postoperative mortality, morbidity, and pain while providing faster recovery, a shorter hospital stay, and better cosmetic results. However, due to technically more demanding procedure, MIS may lead to prolonged CPB time and incomplete de-airing of the heart with an increased risk for cerebral gas embolization. Therefore, the choice of MIS might bear an augmented risk for brain injury. Transcranial Doppler (TCD) enables real time detection of intraoperative emboli in the cerebral arteries seen as microembolic signals (MES), and is an essential neuromonitoring tool. Several studies demonstrated correlation between the number of MES and the occurrence as well as severity of postoperative neurological complications. However, the factors contributing to brain injury have not been elucidated in those studies. The investigators speculate that impairment of CVR is an important mechanism that persists and prolongs the duration of brain injury into postoperative period. The aim of the study is to compare two surgical approaches used for AVR, with focus on the number of MES and their impact on levels of protein S100B (marker of brain tissue damage),postoperative CVR and cognitive function With the results,the investigators aim to help surgeons in selecting the appropriate technique for AVR in individual participants,as well as to clarify the effect of aortic valve surgery on the brain.

Conditions

Brain Injury

Keywords

Aortic valve surgery

Outcome Measures

Primary Outcomes (3)

• Detection of the intraoperative microembolic signals during minimal invasive sternotomy compared to full sternotomy with TCD during aortic valve surgery

  Intraoperative detection:Beginning of surgery, after sternotomy, during aortic cannulation, during CPB, during de-aeration, opening of the clamp on the aorta and after CBP removal before chest closure.

• Detection of S100B serum protein, marker of brain tissue damage

  Before induction of anesthesia, 6 h , 24 h, 48h and 7 days after CPB

• Detection of serum interleukin IL-1, IL-6,IL-8,Il-10 and Microparticles

  Before induction of anesthesia, 6 h , 24 h, 48h and 7 days after CPB

Secondary Outcomes (2)

• Assessment of cerebrovascular reactivity using visually evoked cerebral blood flow velocity response (VEFR) measurements

  7 days before and 7 days after surgery

• Assessment of neurologic and cognitive function in patients undergoing AVR

  7 days before and 7 days after surgery

Other Outcomes (4)

• Length of ICU stay

  Post operative period, an expected average of 2 days

• Requirement for inotropic and vasoactive therapy

  1)After induction of anesthesia, 2)at the end of CPB ,3) postoperative period

• Duration of mechanical ventilation

  postoperative period, an expected average 2 days

Study Arms (2)

AVR preformed with full sternotomy

ACTIVE COMPARATOR

30 patients, 7 days before and after surgery mini mental test and measurement of visual evoked cerebral blood flow response (VEFR) will be done. Transcranial doppler measurements 1. beginning of the surgery, 2.after sternotomy, 3.during aortic cannulation,4.during CPB,5. during de-airing, 6. opening of the clamp on the aorta, 7. after CPB removal before chest closure. Prolonged de airing if needed

Device: Transcranial doppler

AVR preformed with minimal invasive sternotomy

EXPERIMENTAL

30 patients, 7 days before and after surgery mini mental test and measurement of visual evoked cerebral blood flow response (VEFR) will be done. Transcranial doppler measurements 1. beginning of the surgery, 2.after sternotomy, 3.during aortic cannulation,4.during CPB,5. during de-airing, 6. opening of the clamp on the aorta, 7. after CPB removal before chest closure. Prolonged de airing if needed

Device: Transcranial doppler

Interventions

Transcranial doppler DEVICE

Prolonged de airing to decrease the number of MES

AVR preformed with full sternotomy; AVR preformed with minimal invasive sternotomy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Isolated aortic valve stenosis as well as asymptomatic patients with depressed systolic function
• Symptomatic patients with normal or depressed left ventricular function
• Patients with American Society of Anesthesiologist (ASA) physical status classification 2 or 3

You may not qualify if:

• History of brain stroke
• EF less than 20%
• History of alcohol abuse
• Epilepsy of history of psychiatric illness and antipsychotic drugs
• Patients with stenosis on carotid arteries
• Patients with preformed surgery or already stented carotid arteries
• Patients with poor or absent acoustic temporal window
• Diagnosed dementia

Sponsors & Collaborators

• Marija Bozhinovska: lead
• Slovenian Research Agency: collaborator

Study Sites (1)

University Clinical center

Ljubljana, Ljubljana, 1000, Slovenia

Location

Related Publications (1)

• Bozhinovska M, Jenko M, Stupica GT, Klokocovnik T, Ksela J, Jelenc M, Podbregar M, Fabjan A, Sostaric M. Cerebral microemboli in mini-sternotomy compared to mini- thoracotomy for aortic valve replacement: a cross sectional cohort study. J Cardiothorac Surg. 2021 May 24;16(1):142. doi: 10.1186/s13019-021-01509-8.

  PMID: 34030698 DERIVED

MeSH Terms

Conditions

Brain Injuries

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Maja Sostaric, MD, PhD

  University Medical Centre Ljubljana

  STUDY DIRECTOR

• Matej Podbregar, MD, PhD

  University Medical Centre Ljubljana

  STUDY DIRECTOR

• Tomislav Klokocovnik, MD,PhD

  University Medical Centre Ljubljana

  STUDY DIRECTOR

• Borut Gersak, MD, PhD

  University Medical Centre Ljubljana

  STUDY DIRECTOR

• Marija Bozhinovska, MD, MSc

  University Medical Centre Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, MSc, Spec.

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: March 3, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: April 1, 2018
• Last Updated: October 28, 2016

Record last verified: 2016-10

Locations

SL (1)