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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04725708
Other study ID # Bursa YIERH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2019
Est. completion date August 1, 2020

Study information

Verified date March 2023
Source Bursa Yüksek Ihtisas Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date August 1, 2020
Est. primary completion date May 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
procedure: cerebral oxygenation intervention
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.

Locations

Country Name City State
Turkey Bursa YIERH Bursa

Sponsors (1)

Lead Sponsor Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary postoperative neurocognitive function Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language. 12 hours after surgery
Primary postoperative neurocognitive function Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language. 24 hours after surgery
Primary postoperative neurocognitive function Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language. 1 month after surgery
Primary postoperative neurocognitive function Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language. 3 months after surgery
Primary postoperative neurocognitive function Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language. 6 months after surgery
Secondary Extubation time after surgery Weaning times from mechanical ventilation among patients who are followed up with the same intensive care approach after surgery During the hospitalization for postoperative recovery ,average 8 days
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