NeurosurgeryEPODNCT06894238
Electroencephalogram Predicts Post-operative Delirium
An observational study of Neurosurgery and Delirium - Postoperative, run by Beijing Sanbo Brain Hospital at 2 sites in China.
Trial summary
The goal of this observational study is to investigate the predictive value of sub-hairline electroencephalography (EEG) during anesthesia recovery for postoperative delirium (POD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurosurgery, Delirium - Postoperative, Brain Tumor Adult
- What is being tested?
- Sub-hairline EEG Monitoring
- How many people
- 137 participants
- Where
- 2 sitesChina
- Study dates
- 1 Mar 2025to 1 May 2026
- How long will I take part?
- 30 Days
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will recruit participants from patients scheduled for elective neurosurgical procedures at Sanbo Brain Hospital, Capital Medical Universtiy in Beijing, China. The population will consist of adult patients aged ≥18 years who are classified as ASA physical status I-II, indicating generally healthy individuals or those with mild systemic disease. Participants will be identified through pre-surgical assessments and referred by their attending neurosurgeons for enrollment in the study. This cohort will be selected from those undergoing elective craniotomy. Eligible participants will be consented prior to surgery, and sub-hairline EEG monitoring will be initiated during the early anesthesia recovery phase in the ICU.
Who may be able to join
- Age ≥ 18 years
- Planned elective neurosurgical surgery
- ASA physical status I-II
- Signed informed consent
Who cannot join
- Known neurological or psychiatric disorders (e.g., epilepsy, Parkinson's disease)
- Preoperative cognitive impairment (MMSE score < 24)
- Long-term use of central nervous system drugs (e.g., antidepressants, antipsychotics)
- Language barriers
- History of craniotomy within the last 12 months
- Inability to place frontal-temporal electrodes due to conditions such as frontal skin injury, severe agitation, or a coronal incision for surgery
- Pregnant or breastfeeding women
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Beijing Sanbo Brain Hospital, Capital Medical University
Beijing, Beijing Municipality, 100090
Zhonghua Shi, PhD,MD, 010-62856764, z.shi@mail.ccmu.edu.cn
- Recruiting
Sanbo Brain Hospital, Captial Medical Universtiy
Beijing, Beijing Municipality, 100093
Zhonghua Shi, MD, PhD, +86-010-62856765, z.shi@mail.ccmu.edu.cn
About this study
Official title: Frontal-temporal EEG During Anesthesia Recovery Predicts Postoperative Delirium in Neurosurgery: a Single-center, Prospective, Observational Study
The goal of this observational study is to investigate the predictive value of sub-hairline electroencephalography (EEG) during anesthesia recovery for postoperative delirium (POD). The main question to be answered is:
- Can sub-hairline EEG measured during anesthesia recovery serve as a reliable predictor of POD? Adult patients undergoing elective craniotomy and admitted to the ICU will be enrolled. Sub-hairline EEG will be monitored until ICU discharge.
Read the detailed description
Postoperative delirium (POD) is common neurological complication following major surgery, particularly in neurosurgical patients with the incidence ranges from 5% to 37%, depending on the diagnostic criteria and patient subgroups. POD has been associated with increased morbidity, prolonged hospitalisation, long-term cognitive impairment, and higher healthcare costs. Despite its clinical significance, early identification of patients at risk for POD remains a challenge. Electroencephalography (EEG) has been extensively utilised for monitoring brain function in anaesthesia and critical care settings. However, the feasibility and predictive value of sub-hairline EEG during anaesthesia recovery for POD remain largely unexplored.
This prospective observational study aims to assess whether sub-hairline EEG parameters recorded during the immediate anaesthesia recovery phase can serve as reliable predictors of POD in adult patients undergoing elective craniotomy. The study will include patients scheduled for elective craniotomy who are admitted to the intensive care unit (ICU) postoperatively.
Study Design and Procedures
Sub-hairline EEG monitoring will commence at the end of surgery and continue throughout the early recovery phase in the ICU. EEG signals will be continuously recorded using a standardized EEG montage, focusing on frontal and temporal regions. The EEG-derived parameters of interest include:
- Spectral power across different frequency bands (delta, theta, alpha, beta)
- Burst suppression ratio
- Functional connectivity metrics (coherence, phase-amplitude coupling) POD will be assessed using validated screening tools, including the Confusion Assessment Method for the ICU (CAM-ICU), the Delirium Observation Screening Scale (DOSS), and the Fluctuating Mental Status Evaluation (FMSE) within seven days postoperatively. Assessments will be conducted after extubation and between 10:00 AM and 4:00 PM within the first seven postoperative days. A total of four visits will be performed: on postoperative day 1, postoperative day 7, and two randomly selected days between postoperative days 2 and 5.
Data Collection and Quality Assurance
To ensure data quality and integrity, the study will implement the following procedures:
- Standardized EEG Acquisition and Processing: EEG signals will be collected using a predefined protocol with strict artifact rejection criteria.
- Clinical Data Recording: Patient demographics, perioperative anesthetic management, hemodynamic stability, postoperative analgesia, respiratory function, and ECG parameters will be recorded to assess potential confounding factors.
- Source Data Verification: EEG recordings and clinical data will be cross-checked with electronic medical records for accuracy and completeness.
- Quality Control Measures: Data entry will undergo automated range and consistency checks to minimize errors. Missing or inconsistent data will be flagged and reviewed.
Sample Size and Statistical Analysis Plan A sample size calculation will be conducted to ensure adequate power to detect significant associations between EEG parameters and POD incidence. Based on our past studies, the incidence of POD is 30% after neurosurgery in our hospital. According to the literature search results and related studies, the area under the curve was 0.73, the two-sided test error was 0.05, the statistical power was 0.9, and the 10% dropout rate was considered. Eventually, we plan to enroll 137 participants for elective neurosurgery.
Primary Analysis:
- The association between EEG parameters during anesthesia recovery and POD will be evaluated using multivariable logistic regression, adjusting for potential confounders.
- Time-series EEG changes will be analyzed using repeated-measures ANOVA to track EEG dynamics over time.
Secondary Analysis:
- EEG biomarkers predictive of POD severity will be identified using machine learning approaches, such as decision trees and support vector machines.
- Subgroup analysis will assess differences based on age, baseline cognitive function, and surgical duration.
Expected Impact By leveraging non-invasive sub-hairline EEG monitoring, this study aims to provide insights into the neurophysiological mechanisms underlying POD and identify early EEG biomarkers for risk stratification. If successful, this research could contribute to the development of real-time EEG-based monitoring tools for early POD detection and prevention, ultimately improving postoperative outcomes in neurosurgical patients.
- Conditions
- Neurosurgery, Delirium - Postoperative, Brain Tumor Adult
- Being tested
- Sub-hairline EEG Monitoring
- Keywords
- Postoperative delirium, electroencephalography, neurosurgical patients, Sub-hairline EEG, Confusion Assessment Method for ICU (CAM-ICU), Delirium Observation Screening Scale (DOSS), Fluctuating Mental Status Evaluation (FMSE)
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sub-hairline EEG MonitoringDiagnostic test
Also called Delirium Assessment, Clinical Data Collection
Participants will receive standard postoperative care as per institutional protocols, including neuromonitoring, delirium screening, and ICU management. The study will not alter or assign any treatments but will analyze the association between sub-hairline EEG parameters and postoperative delirium (POD) outcomes
| Study group | Role | What they receive |
|---|---|---|
| POD group | Patients who develop POD within seven days after surgery, as assessed using validated screening tools (CAM-ICU, DOSS, FMSE) Receives: Diagnostic Test: Sub-hairline EEG Monitoring | |
| Non-POD group | Patients who do not develop POD within the seven-day postoperative period. Receives: Diagnostic Test: Sub-hairline EEG Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Delirium (POD)
The primary outcome of this study is to assess whether sub-hairline EEG parameters recorded during anesthesia recovery can reliably predict the incidence of postoperative delirium (POD) within the first 7 days following elective craniotomy.
Measured: Within 7 days post-surgery
Secondary outcomes (5)
Spectral power of Sub-Hairline EEG theta wave
To evaluate whether changes in sub-hairline EEG parameters (e.g., spectral power, burst suppression ratio, and connectivity metrics) during the early postoperative period are associated with the onset and severity of POD.
Measured: Within 7 days post-surgery
Hospital Length of Stay
To investigate if the use of sub-hairline EEG during anesthesia recovery correlates with the length of ICU and total hospital stay.
Measured: through study completion, an average of 30 days
Incidence of Postoperative Complications (PPCs)
To evaluate the incidence of postoperative complications, including pneumonia, atelectasis, brain ischemia, edema, and haemorrhage, and whether these are correlated with sub-hairline EEG parameters.
Measured: through study completion, an average of 1 week
Analysis of EEG Patterns and Delirium Onset
To explore any correlation between specific sub-hairline EEG patterns (e.g., burst suppression ratio, alpha or theta waves) and the early onset of delirium.
Measured: through study completion, an average of 1 week
Phase-Locking Value between sub-Hairline EEG oscillations and respiratory rhythm
This secondary outcome measure aims to investigate the correlation between sub-hairline EEG parameters and other physiological signals, including electrocardiogram (ECG) and respiratory parameters, to determine their potential predictive value for POD. This study will explore whether these signals show significant interactions or patterns that could help predict the onset of POD and its severity.
Measured: through study completion, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start1 Mar 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurosurgeryStudies 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
- 137 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Beijing Sanbo Brain Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhonghua Shi, MD, PhD, Capital Medical University
- Investigators
- Zhonghua Shi, PhD,MD, Principal investigator, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894238
- Sponsor's protocol ID
- -BeijingSBH
- Other IDs
- SB-
- Acronym
- EPOD
- Status last verified
- Feb 2025
- First submitted
- 12 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frontal-temporal EEG During Anesthesia Recovery Predicts Postoperative Delirium in Neurosurgery: a Single-center, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT06894238
- Acronym / sponsor ID
- EPOD / -BeijingSBH
- Conditions
- Neurosurgery, Delirium - Postoperative, Brain Tumor Adult
- Keywords
- Postoperative delirium, electroencephalography, neurosurgical patients, Sub-hairline EEG, Confusion Assessment Method for ICU (CAM-ICU), Delirium Observation Screening Scale (DOSS), Fluctuating Mental Status Evaluation (FMSE)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 137 participants (estimated)
- Lead sponsor
- Beijing Sanbo Brain HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 25 Mar 2025 (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 goal of this observational study is to investigate the predictive value of sub-hairline electroencephalography (EEG) during anesthesia recovery for postoperative delirium (POD). The main question to be answered is:
- Can sub-hairline EEG measured during anesthesia recovery serve as a reliable predictor of POD? Adult patients undergoing elective craniotomy and admitted to the ICU will be enrolled. Sub-hairline EEG will be monitored until ICU discharge.
Detailed description
Postoperative delirium (POD) is common neurological complication following major surgery, particularly in neurosurgical patients with the incidence ranges from 5% to 37%, depending on the diagnostic criteria and patient subgroups. POD has been associated with increased morbidity, prolonged hospitalisation, long-term cognitive impairment, and higher healthcare costs. Despite its clinical significance, early identification of patients at risk for POD remains a challenge. Electroencephalography (EEG) has been extensively utilised for monitoring brain function in anaesthesia and critical care settings. However, the feasibility and predictive value of sub-hairline EEG during anaesthesia recovery for POD remain largely unexplored.
This prospective observational study aims to assess whether sub-hairline EEG parameters recorded during the immediate anaesthesia recovery phase can serve as reliable predictors of POD in adult patients undergoing elective craniotomy. The study will include patients scheduled for elective craniotomy who are admitted to the intensive care unit (ICU) postoperatively.
Study Design and Procedures
Sub-hairline EEG monitoring will commence at the end of surgery and continue throughout the early recovery phase in the ICU. EEG signals will be continuously recorded using a standardized EEG montage, focusing on frontal and temporal regions. The EEG-derived parameters of interest include:
- Spectral power across different frequency bands (delta, theta, alpha, beta)
- Burst suppression ratio
- Functional connectivity metrics (coherence, phase-amplitude coupling) POD will be assessed using validated screening tools, including the Confusion Assessment Method for the ICU (CAM-ICU), the Delirium Observation Screening Scale (DOSS), and the Fluctuating Mental Status Evaluation (FMSE) within seven days postoperatively. Assessments will be conducted after extubation and between 10:00 AM and 4:00 PM within the first seven postoperative days. A total of four visits will be performed: on postoperative day 1, postoperative day 7, and two randomly selected days between postoperative days 2 and 5.
Data Collection and Quality Assurance
To ensure data quality and integrity, the study will implement the following procedures:
- Standardized EEG Acquisition and Processing: EEG signals will be collected using a predefined protocol with strict artifact rejection criteria.
- Clinical Data Recording: Patient demographics, perioperative anesthetic management, hemodynamic stability, postoperative analgesia, respiratory function, and ECG parameters will be recorded to assess potential confounding factors.
- Source Data Verification: EEG recordings and clinical data will be cross-checked with electronic medical records for accuracy and completeness.
- Quality Control Measures: Data entry will undergo automated range and consistency checks to minimize errors. Missing or inconsistent data will be flagged and reviewed.
Sample Size and Statistical Analysis Plan A sample size calculation will be conducted to ensure adequate power to detect significant associations between EEG parameters and POD incidence. Based on our past studies, the incidence of POD is 30% after neurosurgery in our hospital. According to the literature search results and related studies, the area under the curve was 0.73, the two-sided test error was 0.05, the statistical power was 0.9, and the 10% dropout rate was considered. Eventually, we plan to enroll 137 participants for elective neurosurgery.
Primary Analysis:
- The association between EEG parameters during anesthesia recovery and POD will be evaluated using multivariable logistic regression, adjusting for potential confounders.
- Time-series EEG changes will be analyzed using repeated-measures ANOVA to track EEG dynamics over time.
Secondary Analysis:
- EEG biomarkers predictive of POD severity will be identified using machine learning approaches, such as decision trees and support vector machines.
- Subgroup analysis will assess differences based on age, baseline cognitive function, and surgical duration.
Expected Impact By leveraging non-invasive sub-hairline EEG monitoring, this study aims to provide insights into the neurophysiological mechanisms underlying POD and identify early EEG biomarkers for risk stratification. If successful, this research could contribute to the development of real-time EEG-based monitoring tools for early POD detection and prevention, ultimately improving postoperative outcomes in neurosurgical patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POD group | – | Diagnostic Test: Sub-hairline EEG MonitoringPatients who develop POD within seven days after surgery, as assessed using validated screening tools (CAM-ICU, DOSS, FMSE) |
| Non-POD group | – | Diagnostic Test: Sub-hairline EEG MonitoringPatients who do not develop POD within the seven-day postoperative period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will recruit participants from patients scheduled for elective neurosurgical procedures at Sanbo Brain Hospital, Capital Medical Universtiy in Beijing, China. The population will consist of adult patients aged ≥18 years who are classified as ASA physical status I-II, indicating generally healthy individuals or those with mild systemic disease. Participants will be identified through pre-surgical assessments and referred by their attending neurosurgeons for enrollment in the study. This cohort will be selected from those undergoing elective craniotomy. Eligible participants will be consented prior to surgery, and sub-hairline EEG monitoring will be initiated during the early anesthesia recovery phase in the ICU.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Planned elective neurosurgical surgery
- ASA physical status I-II
- Signed informed consent
Key exclusion criteria (7 listed)
- Known neurological or psychiatric disorders (e.g., epilepsy, Parkinson's disease)
- Preoperative cognitive impairment (MMSE score < 24)
- Long-term use of central nervous system drugs (e.g., antidepressants, antipsychotics)
- Language barriers
- History of craniotomy within the last 12 months
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 |
|---|---|---|
| Sub-hairline EEG MonitoringAlso: Delirium Assessment, Clinical Data CollectionParticipants will receive standard postoperative care as per institutional protocols, including neuromonitoring, delirium screening, and ICU management. The study will not alter or assign any treatments but will analyze the association between sub-hairline EEG parameters and postoperative delirium (POD) outcomes | Diagnostic test | Non-POD group, POD group |
Primary outcome
Incidence of Postoperative Delirium (POD)
Time frame: Within 7 days post-surgery
The primary outcome of this study is to assess whether sub-hairline EEG parameters recorded during anesthesia recovery can reliably predict the incidence of postoperative delirium (POD) within the first 7 days following elective craniotomy.
5 secondary outcomes
Spectral power of Sub-Hairline EEG theta wave
Time frame: Within 7 days post-surgery
Hospital Length of Stay
Time frame: through study completion, an average of 30 days
Incidence of Postoperative Complications (PPCs)
Time frame: through study completion, an average of 1 week
Analysis of EEG Patterns and Delirium Onset
Time frame: through study completion, an average of 1 week
Phase-Locking Value between sub-Hairline EEG oscillations and respiratory rhythm
Time frame: through study completion, an average of 1 week
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 25 Mar 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.
Zhonghua Shi, PhD,MD principal investigator
Capital Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurosurgery and Delirium - Postoperative, run by Beijing Sanbo Brain Hospital at 2 sites 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 4 inclusion and 7 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 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Zhonghua Shi, PhD,MD (010-62856764, z.shi@mail.ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Delirium (POD) (time frame: Within 7 days post-surgery). 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 25 Mar 2025; AzTrials last refreshed its copy on 29 Oct 2026.