StrokeONSD-MiECCNCT07661238
Effect of Minimally Invasive Extracorporeal Circulation on Optic Nerve Sheath Diameter and Stroke Incidence in Isolated Open Heart Surgery
An observational study of Stroke and Cardiac Surgery, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective randomized controlled trial compares the effects of Minimally Invasive Extracorporeal Circulation (MiECC) versus conventional cardiopulmonary bypass (CPB) on optic nerve sheath diameter (ONSD) and postoperative stroke incidence in adult patients undergoing isolated open heart surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Cardiac Surgery, Cardiopulmonary Bypass
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ,elective 18-80 aged, coronary bypass surgery patients with pump convansionel and MIECC
Who may be able to join
- Age 18 to 80 years
- Scheduled for elective isolated open heart surgery
- Requires cardiopulmonary bypass
- Able to provide written informed consent
- Adequate ultrasonographic window for ONSD measurement
Who cannot join
- Emergency or salvage surgery
- Off-pump, revision, or combined cardiac surgery
- History of stroke or TIA within the last 6 months
- Pre-existing neurological deficit
- Bilateral optic nerve pathology
- History of ocular trauma or surgery
Show all 14Show fewer
- Intracranial mass or hydrocephalus
- Requirement for deep hypothermic circulatory arrest
- Alcohol or substance dependency
- Left ventricular ejection fraction <30%
- Renal or hepatic failure with risk of advanced encephalopathy
- Preoperative requirement for mechanical circulatory support
- Symptomatic or severe carotid artery stenosis (>70%)
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Bursa Yüksek Ihtisas Training and Research Hospital
Bursa, Yıldırım, 16600
About this study
This prospective randomized controlled trial compares the effects of Minimally Invasive Extracorporeal Circulation (MiECC) versus conventional cardiopulmonary bypass (CPB) on optic nerve sheath diameter (ONSD) and postoperative stroke incidence in adult patients undergoing isolated open heart surgery. ONSD will be measured by ultrasound at 7 predefined time points (T0-T6). Primary outcomes include perioperative ONSD changes and 30-day stroke incidence. Secondary outcomes include TIA, delirium (CAM-ICU), MoCA scores, ICU and hospital stay, AKI, and transfusion requirements.
Read the detailed description
Cardiopulmonary bypass (CPB)-associated neurological complications remain a significant concern in cardiac surgery, with stroke incidence ranging from 1.3% to 3.6% depending on procedure type, patient age, and comorbidities. The underlying mechanism involves cerebral embolism, hypoperfusion, and ischemia-reperfusion injury, with microemboli and hypoperfusion acting synergistically to impair cerebral washout - particularly in watershed regions.Minimally Invasive Extracorporeal Circulation (MiECC) systems were developed to improve biocompatibility, minimize adverse effects, and enhance end-organ protection compared to conventional CPB. MiECC utilizes a closed-circuit system with no venous reservoir, heparin-coated tubing, kinetic-assisted venous drainage, and a minimal prime volume (~500-700 mL), which significantly improves microcirculation and renders cardiac surgery more physiological.Optic nerve sheath diameter (ONSD), measured by ultrasound, provides a non-invasive, objective, and reproducible method for assessing intracranial pressure (ICP). The optic nerve sheath communicates with the subarachnoid space and dilates in response to elevated ICP. An ONSD exceeding 5.35 mm has been shown to correlate strongly with ICP above 20 mmHg on CT measurement.
In this prospective randomized controlled trial, adult patients undergoing elective isolated open heart surgery will be randomized into two groups: MiECC (n=50) and conventional CPB (n=50). Anesthesia will be standardized across both groups. ONSD will be measured bilaterally at 7 predefined time points (T0: preoperative baseline; T1: 15 min after CPB onset; T2: mid-CPB during cross-clamp; T3: before CPB weaning; T4: 30 min post-CPB; T5: postoperative hour 6; T6: postoperative hour 24) using a high-frequency linear probe (7.5-10 MHz), with measurements taken 3 mm behind the optic disc. Cerebral oxygenation will be monitored by NIRS.Neurological assessment will include full neurological examination, MoCA testing (preoperative, postoperative day 7 and 30), CAM-ICU delirium scoring (daily in ICU), and brain CT/MRI in case of suspected stroke. Stroke is defined as focal or global neurological deficit lasting more than 24 hours, confirmed by neuroimaging and graded by NIHSS.
The study aims to determine whether MiECC reduces perioperative intracranial pressure elevation (as reflected by ONSD) and postoperative stroke incidence compared to conventional CPB, and to evaluate the utility of ONSD as a routine non-invasive stroke predictor in open heart surgery.
- Conditions
- Stroke, Cardiac Surgery, Cardiopulmonary Bypass
- Keywords
- Optic Nerve Sheath Diameter, Minimally Invasive Extracorporeal Circulation, Neurological Complications, Cardiac Surgery
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MiECC Group | Patients undergoing isolated open heart surgery using minimally invasive extracorporeal circulation (closed-circuit, no venous reservoir, heparin-coated tubing, minimal prime volume ~500-700 mL) | |
| Conventional CPB Group | Patients undergoing isolated open heart surgery using conventional cardiopulmonary bypass (open cardiotomy reservoir, gravity drainage, prime volume ~1500-2000 mL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ONSD change from baseline (T0 to T6)
Bilateral ONSD measured by ultrasound (7.5-10 MHz linear probe) at 3 mm posterior to the optic disc. Three measurements per eye, mean value recorded. Change assessed from preoperative baseline (T0) through postoperative hour 24 (T6).
Measured: Measured by ultrasound at 7 time points intraoperative time period
30-day stroke incidence
Stroke defined as focal or global neurological deficit lasting more than 24 hours, confirmed by neuroimaging (CT or MRI), and graded by NIHSS score.
Measured: postoperative 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Nov 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
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 HospitalAygül A GÜNEŞ, MD, Principal investigator, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661238
- Sponsor's protocol ID
- 2024-TBEK 2025/10-06
- Acronym
- ONSD-MiECC
- Status last verified
- Jun 2026
- First submitted
- 7 May 2026
- Last updated
- 22 Jun 2026
- 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 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Minimally Invasive Extracorporeal Circulation on Optic Nerve Sheath Diameter and Stroke Incidence in Isolated Open Heart Surgery
- ClinicalTrials.gov ID
- NCT07661238
- Acronym / sponsor ID
- ONSD-MiECC / 2024-TBEK 2025/10-06
- Conditions
- Stroke, Cardiac Surgery, Cardiopulmonary Bypass
- Keywords
- Optic Nerve Sheath Diameter, Minimally Invasive Extracorporeal Circulation, Neurological Complications, Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 22 Jun 2026 (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.
This prospective randomized controlled trial compares the effects of Minimally Invasive Extracorporeal Circulation (MiECC) versus conventional cardiopulmonary bypass (CPB) on optic nerve sheath diameter (ONSD) and postoperative stroke incidence in adult patients undergoing isolated open heart surgery. ONSD will be measured by ultrasound at 7 predefined time points (T0-T6). Primary outcomes include perioperative ONSD changes and 30-day stroke incidence. Secondary outcomes include TIA, delirium (CAM-ICU), MoCA scores, ICU and hospital stay, AKI, and transfusion requirements.
Detailed description
Cardiopulmonary bypass (CPB)-associated neurological complications remain a significant concern in cardiac surgery, with stroke incidence ranging from 1.3% to 3.6% depending on procedure type, patient age, and comorbidities. The underlying mechanism involves cerebral embolism, hypoperfusion, and ischemia-reperfusion injury, with microemboli and hypoperfusion acting synergistically to impair cerebral washout - particularly in watershed regions.Minimally Invasive Extracorporeal Circulation (MiECC) systems were developed to improve biocompatibility, minimize adverse effects, and enhance end-organ protection compared to conventional CPB. MiECC utilizes a closed-circuit system with no venous reservoir, heparin-coated tubing, kinetic-assisted venous drainage, and a minimal prime volume (~500-700 mL), which significantly improves microcirculation and renders cardiac surgery more physiological.Optic nerve sheath diameter (ONSD), measured by ultrasound, provides a non-invasive, objective, and reproducible method for assessing intracranial pressure (ICP). The optic nerve sheath communicates with the subarachnoid space and dilates in response to elevated ICP. An ONSD exceeding 5.35 mm has been shown to correlate strongly with ICP above 20 mmHg on CT measurement.
In this prospective randomized controlled trial, adult patients undergoing elective isolated open heart surgery will be randomized into two groups: MiECC (n=50) and conventional CPB (n=50). Anesthesia will be standardized across both groups. ONSD will be measured bilaterally at 7 predefined time points (T0: preoperative baseline; T1: 15 min after CPB onset; T2: mid-CPB during cross-clamp; T3: before CPB weaning; T4: 30 min post-CPB; T5: postoperative hour 6; T6: postoperative hour 24) using a high-frequency linear probe (7.5-10 MHz), with measurements taken 3 mm behind the optic disc. Cerebral oxygenation will be monitored by NIRS.Neurological assessment will include full neurological examination, MoCA testing (preoperative, postoperative day 7 and 30), CAM-ICU delirium scoring (daily in ICU), and brain CT/MRI in case of suspected stroke. Stroke is defined as focal or global neurological deficit lasting more than 24 hours, confirmed by neuroimaging and graded by NIHSS.
The study aims to determine whether MiECC reduces perioperative intracranial pressure elevation (as reflected by ONSD) and postoperative stroke incidence compared to conventional CPB, and to evaluate the utility of ONSD as a routine non-invasive stroke predictor in open heart surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MiECC Group | – | –Patients undergoing isolated open heart surgery using minimally invasive extracorporeal circulation (closed-circuit, no venous reservoir, heparin-coated tubing, minimal prime volume ~500-700 mL) |
| Conventional CPB Group | – | –Patients undergoing isolated open heart surgery using conventional cardiopulmonary bypass (open cardiotomy reservoir, gravity drainage, prime volume ~1500-2000 mL) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ,elective 18-80 aged, coronary bypass surgery patients with pump convansionel and MIECC
Key inclusion criteria (5 listed)
- Age 18 to 80 years
- Scheduled for elective isolated open heart surgery
- Requires cardiopulmonary bypass
- Able to provide written informed consent
- Adequate ultrasonographic window for ONSD measurement
Key exclusion criteria (14 listed)
- Emergency or salvage surgery
- Off-pump, revision, or combined cardiac surgery
- History of stroke or TIA within the last 6 months
- Pre-existing neurological deficit
- Bilateral optic nerve pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ONSD change from baseline (T0 to T6)
Time frame: Measured by ultrasound at 7 time points intraoperative time period
Bilateral ONSD measured by ultrasound (7.5-10 MHz linear probe) at 3 mm posterior to the optic disc. Three measurements per eye, mean value recorded. Change assessed from preoperative baseline (T0) through postoperative hour 24 (T6).
30-day stroke incidence
Time frame: postoperative 30 days
Stroke defined as focal or global neurological deficit lasting more than 24 hours, confirmed by neuroimaging (CT or MRI), and graded by NIHSS score.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- 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
Aygül A GÜNEŞ, MD principal investigator
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?
An observational study of Stroke and Cardiac Surgery, 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 5 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
ONSD change from baseline (T0 to T6) (time frame: Measured by ultrasound at 7 time points intraoperative time period). The study lists 2 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 22 Jun 2026.