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Cognitive Functions on Coronary Surgery

Primary Purpose

Neurocognitive Disorders

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
procedure: cerebral oxygenation intervention
Sponsored by
Bursa Yüksek İhtisas Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neurocognitive Disorders focused on measuring cardiovascular surgery, cerebral oxymetre, neurocognitive assessment

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adult patients scheduled to undergo elective cardiopulmonary bypass graft surgery

Exclusion Criteria:

  • severe preoperative cognitive impairment(i.e. dementia, intellectual disorder)
  • Non-Turkish speaking patients
  • presence of end-stage organ failure
  • patients requiring emergency coronary surgery
  • surgical procedures requiring single lung ventilation

Sites / Locations

  • Bursa YIERH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

normoxy

hyperoxia

Arm Description

Group 1(n=50) FiO2%40, PaO2<180 ve PaO2≥80mmHg MMSE will be applied to patients before surgery. At the determined measurement times body and blood temperature, SpO2, HR, MAP, PH, blood gas lactate, blood gas base deficit, urine output, PaO2, PaCO2, Htc, FiO2, right and left rSO2 values were monitored. An rSO2 less than 45% triggered an alarm, the anesthesiologist timed the event, and after 60 seconds initiated an intervention protocol means; PaO2 levels were checked, PaO2> 100 mmHg was achieved, if not improved, pump blood flow, mean arterial pressure were increased, if there is still no response and hematocrit <20%, patients were scheduled for erythrocyte transfusion until the rSO2 was restored to at least 60% at both probes.In the postoperative period, at the 24th hour, when routine cardiological controls were performed 1., 3., 6. Simultaneous MMSE will be repeated in months.

Group 2(n=50) FiO2%100, PaO2≥180mmHg MMSE will be applied to patients before surgery. At the determined measurement times body and blood temperature, SpO2, HR, MAP, PH, blood gas lactate, blood gas base deficit, urine output, PaO2, PaCO2, Htc, FiO2, right and left rSO2 values were monitored..In the postoperative period, at the 24th hour, when routine cardiological controls were performed 1., 3., 6. Simultaneous MMSE will be repeated in months.

Outcomes

Primary Outcome Measures

postoperative neurocognitive function
Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.
postoperative neurocognitive function
Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.
postoperative neurocognitive function
Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.
postoperative neurocognitive function
Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.
postoperative neurocognitive function
Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.

Secondary Outcome Measures

Extubation time after surgery
Weaning times from mechanical ventilation among patients who are followed up with the same intensive care approach after surgery

Full Information

First Posted
January 20, 2021
Last Updated
March 28, 2023
Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04725708
Brief Title
Cognitive Functions on Coronary Surgery
Official Title
The Effect of Intraoperative Arterial Oxygen Levels on Cognitive Functions After Coronary Bypass Graft Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bursa Yüksek İhtisas Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to examine the effects of different but safe levels of arterial oxygen levels used in cardiac surgeries on cerebral oxygenation during the operation. It is also to investigate the effect on cognitive functions in the postoperative period. For our study the investigators will conduct a randomized control trial. Patients will be randomly assigned to one of two possible study groups according to the arterial oxygen levels.If there is any abnormality in cerebral oxygen levels during surgery, necessary intervention will be made by doctors.
Detailed Description
In most cardiovascular surgeries, patients are frequently followed up at hyperoxemic level for safety purposes against the risk of tissue hypoxia that may develop during surgery due to CPB use. At the level of hyperoxemia, there are opinions that the ischemia-reperfusion damage increases with the follow-up of CABG surgery, microcirculation is impaired and tissue oxygenation is impaired due to the resulting hyperoxemic vasoconstriction. Recent research has focused on evaluating optimal oxygen levels in CPB during cardiac surgery. However, the potential of tightly regulated intraoperative normoxia to improve POCD following cardiac surgery has not been studied prospectively. The purpose of this study is to determine whether patients who underwent CPB and CABG, which were preserved under normoxic conditions during the intraoperative period, would have a lower incidence of early and late POCD than those exposed to hyperoxia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurocognitive Disorders
Keywords
cardiovascular surgery, cerebral oxymetre, neurocognitive assessment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
normoxy
Arm Type
Experimental
Arm Description
Group 1(n=50) FiO2%40, PaO2<180 ve PaO2≥80mmHg MMSE will be applied to patients before surgery. At the determined measurement times body and blood temperature, SpO2, HR, MAP, PH, blood gas lactate, blood gas base deficit, urine output, PaO2, PaCO2, Htc, FiO2, right and left rSO2 values were monitored. An rSO2 less than 45% triggered an alarm, the anesthesiologist timed the event, and after 60 seconds initiated an intervention protocol means; PaO2 levels were checked, PaO2> 100 mmHg was achieved, if not improved, pump blood flow, mean arterial pressure were increased, if there is still no response and hematocrit <20%, patients were scheduled for erythrocyte transfusion until the rSO2 was restored to at least 60% at both probes.In the postoperative period, at the 24th hour, when routine cardiological controls were performed 1., 3., 6. Simultaneous MMSE will be repeated in months.
Arm Title
hyperoxia
Arm Type
Experimental
Arm Description
Group 2(n=50) FiO2%100, PaO2≥180mmHg MMSE will be applied to patients before surgery. At the determined measurement times body and blood temperature, SpO2, HR, MAP, PH, blood gas lactate, blood gas base deficit, urine output, PaO2, PaCO2, Htc, FiO2, right and left rSO2 values were monitored..In the postoperative period, at the 24th hour, when routine cardiological controls were performed 1., 3., 6. Simultaneous MMSE will be repeated in months.
Intervention Type
Procedure
Intervention Name(s)
procedure: cerebral oxygenation intervention
Intervention Description
During the surgery, cerebral oxygenation will be followed and intervention will be made to pH, PaO2, PaCO2, mean arterial pressure, hematocrit when necessary. In addition perfusion flow was maintained at or close to between 2.2-2.5 L/min/m2 . Perfusion pressure was adjusted using a phenylephrine infusion to maintain a mean arterial pressure of 50 to 70 mm Hg.
Primary Outcome Measure Information:
Title
postoperative neurocognitive function
Description
Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.
Time Frame
12 hours after surgery
Title
postoperative neurocognitive function
Description
Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.
Time Frame
24 hours after surgery
Title
postoperative neurocognitive function
Description
Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.
Time Frame
1 month after surgery
Title
postoperative neurocognitive function
Description
Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.
Time Frame
3 months after surgery
Title
postoperative neurocognitive function
Description
Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.
Time Frame
6 months after surgery
Secondary Outcome Measure Information:
Title
Extubation time after surgery
Description
Weaning times from mechanical ventilation among patients who are followed up with the same intensive care approach after surgery
Time Frame
During the hospitalization for postoperative recovery ,average 8 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients scheduled to undergo elective cardiopulmonary bypass graft surgery Exclusion Criteria: severe preoperative cognitive impairment(i.e. dementia, intellectual disorder) Non-Turkish speaking patients presence of end-stage organ failure patients requiring emergency coronary surgery surgical procedures requiring single lung ventilation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuğba T ONUR, MD
Organizational Affiliation
Bursa Yüksek İhtisas Education and Research Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ümran Ü KARACA, MD
Organizational Affiliation
Bursa Yüksek İhtisas Education and Research Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Filiz F ATA, MD
Organizational Affiliation
Bursa Yüksek İhtisas Education and Research Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Halil Erkan H SAYAN, MD
Organizational Affiliation
Bursa Yüksek İhtisas Education and Research Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anıl A ONUR, MD
Organizational Affiliation
Bursa Yüksek İhtisas Education and Research Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Canan C YILMAZ, MD
Organizational Affiliation
Bursa Yüksek İhtisas Education and Research Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ayşe Neslihan AN BALKAYA, MD
Organizational Affiliation
Bursa Yüksek İhtisas Education and Research Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cüneyt C ERİŞ
Organizational Affiliation
Bursa Yüksek İhtisas Education and Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Bursa YIERH
City
Bursa
ZIP/Postal Code
16200
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Cognitive Functions on Coronary Surgery

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