Cerebral Oxygen SaturationNCT05198635
Association Between Local Cerebral Oxygenation Monitoring and Postoperative Delirium in Carotid Endarterectomy
An observational study of Cerebral Oxygen Saturation and Postoperative Delirium, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Postoperative delirium (POD) is a common perioperative complication, which can lead to adverse outcomes. Patients undergoing carotid endarterectomy (CEA) were elderly, complicated with vascular risk factors, cognitive dysfunction, some also had a history of stroke, and the circulation fluctuated greatly during the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebral Oxygen Saturation, Postoperative Delirium, Carotid Endarterectomy
- What is being tested?
- local cerebral oxygen saturation
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 14 Feb 2022to 31 Dec 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Scheduled carotid endarterectomy
Who may be able to join
- Scheduled carotid endarterectomy; Signed informed consent.
Who cannot join
- Severe cognitive impairment(Mini-Mental State Examination, MMSE<18); History of psychotropic drugs; Previous intracranial surgery history; Poor hearing or vision; Language barriers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tian Tan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100160
Yuming Peng, 8610-59976658, florapym766@163.com
About this study
Official title: Association Between Local Cerebral Oxygen Saturation Monitoring and Postoperative Delirium in Carotid Endarterectomy：A Prospective Cohort Study
Postoperative delirium (POD) is a common perioperative complication, which can lead to adverse outcomes. Patients undergoing carotid endarterectomy (CEA) were elderly, complicated with vascular risk factors, cognitive dysfunction, some also had a history of stroke, and the circulation fluctuated greatly during the operation, often resulting in hypoperfusion of cerebral tissue and hypoxia. Therefore, they're the high-risk group of POD. Near-infrared Spectroscopy (NIRS) can continuously and noninvasively monitor local cerebral oxygen saturation (SctO2) to identify the mismatch of oxygen supply and demand in brain tissue. However, for CEA patients, the association between intraoperative SctO2 changes and POD remains unclear. This study intends to explore the association between them and determine the SctO2 threshold for predicting POD. We will monitor SctO2 intraoperatively, follow up and collect data postoperatively.
- Being tested
- local cerebral oxygen saturation
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local cerebral oxygen saturationDevice
minimum SctO2, SctO2 drop/rise defined by different thresholds, and area under/above the threshold
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Device: local cerebral oxygen saturation | |
| Group 2 | Not described Receives: Device: local cerebral oxygen saturation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative delirium
Postoperative delirium is assessed by the Confusion assessment method for intensive care unit (CAM-ICU) or the 3-minute diagnostic interview for CAM (3D-CAM) when the patient is in intensive care unit or general ward, respectively.
Measured: With postoperative 5 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start14 Feb 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Oxygen SaturationStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuming Peng, Beijing Tiantan Hospital
- Investigators
- Yuming MD Peng, Ph.D, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198635
- Sponsor's protocol ID
- 20220105
- Status last verified
- Feb 2025
- First submitted
- 4 Jan 2022
- Last updated
- 13 Feb 2025
- 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 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Local Cerebral Oxygen Saturation Monitoring and Postoperative Delirium in Carotid Endarterectomy：A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05198635
- Acronym / sponsor ID
- 20220105
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Jan 2022 (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.
Postoperative delirium (POD) is a common perioperative complication, which can lead to adverse outcomes. Patients undergoing carotid endarterectomy (CEA) were elderly, complicated with vascular risk factors, cognitive dysfunction, some also had a history of stroke, and the circulation fluctuated greatly during the operation, often resulting in hypoperfusion of cerebral tissue and hypoxia. Therefore, they're the high-risk group of POD. Near-infrared Spectroscopy (NIRS) can continuously and noninvasively monitor local cerebral oxygen saturation (SctO2) to identify the mismatch of oxygen supply and demand in brain tissue. However, for CEA patients, the association between intraoperative SctO2 changes and POD remains unclear. This study intends to explore the association between them and determine the SctO2 threshold for predicting POD. We will monitor SctO2 intraoperatively, follow up and collect data postoperatively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: local cerebral oxygen saturation |
| Group 2 | – | Device: local cerebral oxygen saturation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Scheduled carotid endarterectomy
Key inclusion criteria (1 listed)
- Scheduled carotid endarterectomy; Signed informed consent.
Key exclusion criteria (1 listed)
- Severe cognitive impairment(Mini-Mental State Examination, MMSE<18); History of psychotropic drugs; Previous intracranial surgery history; Poor hearing or vision; Language barriers
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 |
|---|---|---|
| local cerebral oxygen saturationminimum SctO2, SctO2 drop/rise defined by different thresholds, and area under/above the threshold | Device | Group 1, Group 2 |
Primary outcome
Postoperative delirium
Time frame: With postoperative 5 day
Postoperative delirium is assessed by the Confusion assessment method for intensive care unit (CAM-ICU) or the 3-minute diagnostic interview for CAM (3D-CAM) when the patient is in intensive care unit or general ward, respectively.
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 13 Feb 2025.
- 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.
Yuming MD Peng, Ph.D principal investigator
Beijing Tiantan 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 Cerebral Oxygen Saturation and Postoperative Delirium, run by Beijing Tiantan Hospital at 1 site in China.
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 1 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: looking for participants now, as of the sponsor's last update on 13 Feb 2025. 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 China. 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?
Contact Yuming MD Peng, Ph.D (8610-59976658, florapym766@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative delirium (time frame: With postoperative 5 day). 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 13 Feb 2025.