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Neuromonitoring in Patients During Aortic Valve Replacement (IMLPBIAVR)

Primary Purpose

Brain Injury

Status
Unknown status
Phase
Phase 3
Locations
Slovenia
Study Type
Interventional
Intervention
Transcranial doppler
Sponsored by
Marija Bozhinovska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Brain Injury focused on measuring Aortic valve surgery

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University Clinical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

AVR preformed with full sternotomy

AVR preformed with minimal invasive sternotomy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Detection of the intraoperative microembolic signals during minimal invasive sternotomy compared to full sternotomy with TCD during aortic valve surgery
Detection of S100B serum protein, marker of brain tissue damage
Detection of serum interleukin IL-1, IL-6,IL-8,Il-10 and Microparticles

Secondary Outcome Measures

Assessment of cerebrovascular reactivity using visually evoked cerebral blood flow velocity response (VEFR) measurements
Assessment of neurologic and cognitive function in patients undergoing AVR

Full Information

First Posted
January 25, 2016
Last Updated
October 27, 2016
Sponsor
Marija Bozhinovska
Collaborators
Slovenian Research Agency
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1. Study Identification

Unique Protocol Identification Number
NCT02697786
Brief Title
Neuromonitoring in Patients During Aortic Valve Replacement
Acronym
IMLPBIAVR
Official Title
The Impact of Intraoperative Microemboli Load on Postoperative Brain Injury in Patients Undergoing Aortic Valve Replacement Preformed With Two Different Surgical Approaches
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marija Bozhinovska
Collaborators
Slovenian Research Agency

4. Oversight

5. Study Description

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.
Detailed Description
Patients undergoing for aortic valve replacement will be enrolled in the study after giving the signed informed consent and will be divided in two groups depending on the type of the surgical technique. Either full sternotomy (FS) or minimal invasive sternotomy (MIS) will be performed, both with the use of cardio-pulmonary bypass (CPB).One week before and one week after the surgery patients will undergo mini mental test and measurement of visually evoked cerebral blood flow velocity response (VEFR).Levels of S100B, interleukin (IL) 1, IL 6, IL 8, IL 10 and microparticles will be determined before induction of anesthesia,as well as 6 h, 24 h, 48 h and 7 days after CPB.Each patient will have invasive and non invasive monitoring that will include near infrared spectroscopy (NIRS), bispectral index (BIS) and TCD during surgery.MES will be detected using TCD at the following time-points: beginning of surgery, after sternotomy, during aortic cannulation, during CPB, during de-airing, opening of the clamp on the aorta and after CBP removal before chest closure.All of this data will be documented as well as the demographic characteristics of patients, their preoperative medical status, and intraoperative data (duration of surgery, duration of CPB, hemodynamic parameters, inotropic/vasoactive support,blood and blood components); duration of mechanical ventilation in intensive care unit (ICU), duration of ICU stay, 30-day mortality and morbidity, as well as postoperative complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injury
Keywords
Aortic valve surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AVR preformed with full sternotomy
Arm Type
Active Comparator
Arm Description
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
Arm Title
AVR preformed with minimal invasive sternotomy
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Transcranial doppler
Intervention Description
Prolonged de airing to decrease the number of MES
Primary Outcome Measure Information:
Title
Detection of the intraoperative microembolic signals during minimal invasive sternotomy compared to full sternotomy with TCD during aortic valve surgery
Time Frame
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.
Title
Detection of S100B serum protein, marker of brain tissue damage
Time Frame
Before induction of anesthesia, 6 h , 24 h, 48h and 7 days after CPB
Title
Detection of serum interleukin IL-1, IL-6,IL-8,Il-10 and Microparticles
Time Frame
Before induction of anesthesia, 6 h , 24 h, 48h and 7 days after CPB
Secondary Outcome Measure Information:
Title
Assessment of cerebrovascular reactivity using visually evoked cerebral blood flow velocity response (VEFR) measurements
Time Frame
7 days before and 7 days after surgery
Title
Assessment of neurologic and cognitive function in patients undergoing AVR
Time Frame
7 days before and 7 days after surgery
Other Pre-specified Outcome Measures:
Title
Length of ICU stay
Time Frame
Post operative period, an expected average of 2 days
Title
Requirement for inotropic and vasoactive therapy
Time Frame
1)After induction of anesthesia, 2)at the end of CPB ,3) postoperative period
Title
Duration of mechanical ventilation
Time Frame
postoperative period, an expected average 2 days
Title
30 days mortality
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maja Sostaric, MD, PhD
Organizational Affiliation
University Medical Centre Ljubljana
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Matej Podbregar, MD, PhD
Organizational Affiliation
University Medical Centre Ljubljana
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tomislav Klokocovnik, MD,PhD
Organizational Affiliation
University Medical Centre Ljubljana
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Borut Gersak, MD, PhD
Organizational Affiliation
University Medical Centre Ljubljana
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marija Bozhinovska, MD, MSc
Organizational Affiliation
University Medical Centre Ljubljana
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinical center
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34030698
Citation
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.
Results Reference
derived

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Neuromonitoring in Patients During Aortic Valve Replacement

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