Neurocognitive DisordersNCT04725708
Cognitive Functions on Coronary Surgery
A study testing procedure: cerebral oxygenation intervention in people with Neurocognitive Disorders, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Neurocognitive Disorders
- What is being tested?
- procedure: cerebral oxygenation intervention
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2019to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients scheduled to undergo elective cardiopulmonary bypass graft surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intraoperative Arterial Oxygen Levels on Cognitive Functions After Coronary Bypass Graft Surgery
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.
Read the 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.
- Conditions
- Neurocognitive Disorders
- Being tested
- procedure: cerebral oxygenation intervention
- Keywords
- cardiovascular surgery, cerebral oxymetre, neurocognitive assessment
- Medical subject headings
- Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
procedure: cerebral oxygenation interventionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| normoxy | Experimental | 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. Receives: Procedure: procedure: cerebral oxygenation intervention |
| hyperoxia | Experimental | 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. Receives: Procedure: procedure: cerebral oxygenation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative neurocognitive function
Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.
Measured: 12 hours after surgery
postoperative neurocognitive function
Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.
Measured: 24 hours after surgery
postoperative neurocognitive function
Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.
Measured: 1 month after surgery
postoperative neurocognitive function
Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.
Measured: 3 months after surgery
postoperative neurocognitive function
Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.
Measured: 6 months after surgery
Secondary outcomes (1)
Extubation time after surgery
Weaning times from mechanical ventilation among patients who are followed up with the same intensive care approach after surgery
Measured: During the hospitalization for postoperative recovery ,average 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 Nov 2019
- Primary completion1 May 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tugba Onur, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Tuğba T ONUR, MD, Principal investigator, Bursa Yuksek Ihtisas Training and Research HospitalÜmran Ü KARACA, MD, Study chair, Bursa Yuksek Ihtisas Training and Research HospitalFiliz F ATA, MD, Study chair, Bursa Yuksek Ihtisas Training and Research HospitalHalil Erkan H SAYAN, MD, Study chair, Bursa Yuksek Ihtisas Training and Research HospitalAnıl A ONUR, MD, Study chair, Bursa Yuksek Ihtisas Training and Research HospitalCanan C YILMAZ, MD, Study chair, Bursa Yuksek Ihtisas Training and Research HospitalAyşe Neslihan AN BALKAYA, MD, Study chair, Bursa Yuksek Ihtisas Training and Research HospitalCüneyt C ERİŞ, Study chair, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725708
- Sponsor's protocol ID
- Bursa YIERH
- Status last verified
- Mar 2023
- First submitted
- 20 Jan 2021
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoperative Arterial Oxygen Levels on Cognitive Functions After Coronary Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT04725708
- Acronym / sponsor ID
- Bursa YIERH
- Conditions
- Neurocognitive Disorders
- Keywords
- cardiovascular surgery, cerebral oxymetre, neurocognitive assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normoxy | Experimental | Procedure: procedure: cerebral oxygenation interventionGroup 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. |
| hyperoxia | Experimental | Procedure: procedure: cerebral oxygenation interventionGroup 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients scheduled to undergo elective cardiopulmonary bypass graft surgery
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| procedure: cerebral oxygenation interventionDuring 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. | Procedure or surgery | hyperoxia, normoxy |
Primary outcome
postoperative neurocognitive function
Time frame: 12 hours after surgery
Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.
postoperative neurocognitive function
Time frame: 24 hours after surgery
Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.
postoperative neurocognitive function
Time frame: 1 month after surgery
Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.
postoperative neurocognitive function
Time frame: 3 months after surgery
Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.
postoperative neurocognitive function
Time frame: 6 months after surgery
Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.
1 secondary outcome
Extubation time after surgery
Time frame: During the hospitalization for postoperative recovery ,average 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuğba T ONUR, MD principal investigator
Bursa Yuksek Ihtisas Training and Research Hospital
Ümran Ü KARACA, MD study chair
Bursa Yuksek Ihtisas Training and Research Hospital
Filiz F ATA, MD study chair
Bursa Yuksek Ihtisas Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing procedure: cerebral oxygenation intervention in people with Neurocognitive Disorders, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative neurocognitive function (time frame: 12 hours after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.