ElectroencephalogramNCT04943939
Correlation of Electroencephalogram With Postoperative Delirium During Cardiac Surgery
An observational study of Electroencephalogram and Postoperative Delirium, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial summary
The purpose of this study is to explore characteristic changes of EEG epileptiform discharges in patients under CPB and correlation with POD Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Electroencephalogram, Postoperative Delirium
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 1 Dec 2021
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cardiac surgery patients
Who may be able to join
- ASA II-III;
- No cognitive impairment was assessed one day before surgery;
- Patients undergoing elective CPB cardiac surgery(valvular heart surgery and coronary bypass surgery) and signed informed consent.
Who cannot join
- Non-CPB surgery, macrovascular surgery, heart transplantation, correction of congenital heart disease;
- Stroke, schizophrenia, depression, Parkinson's disease, epilepsy or dementia;
- Inability to communicate with language impairment or major hearing or visual impairment;
- Liver function child-pugh Grade C, severe liver dysfunction;
- Severe renal insufficiency requires preoperative renal replacement therapy;
- A past history of intraoperative knowledge.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
Xinli Ni, PhD,MD, 86-951-674-3252, xinlini6@yahoo.com
About this study
Official title: Correlation of Electroencephalogram Epileptiform Discharges With Postoperative Delirium During Cardiac Surgery
The purpose of this study is to explore characteristic changes of EEG epileptiform discharges in patients under CPB and correlation with POD
Read the detailed description
Cardiac surgery under cardiopulmonary bypass (CPB) as a result of the surgery itself great trauma and CPB this special process can lead to cerebral hypoperfusion, cerebral ischemia, increased in patients with postoperative neurological complications, the incidence of postoperative cognitive dysfunction can up to 44-53%.Postoperative delirium (POD) is not only increase the incidence of postoperative cognitive dysfunction forward, affect the quality of postoperative recovery and increased hospital costs, also associated with postoperative mortality. Although the clinical use of different drugs and technology improve the POD, but due to the mechanism is still unclear, is still lack of effective control measures. Electroencephalogram (EEG) can measure the cerebral cortex and subcortical local potential activities, to reflect the activities of the neurons in the brain. CPB can cause the abnormal vibration of brain waves, epileptiform discharges is the result of abnormal discharge of brain neurons, which is correlated with the occurrence of cognitive dysfunction.But whether EEG epileptiform discharges is related to the POD is uncertain.While epileptic seizures can be treated with anticonvulsant drugs, so the detection and treatment of early epileptic seizures may have important clinical significance for the occurrence of POD. Therefore, the main purpose of this study is to explore characteristic changes of EEG epileptiform discharges in patients under CPB and correlation with POD, offer the theoretical foundation for delirium early warning and prevention.
- Conditions
- Electroencephalogram, Postoperative Delirium
- Keywords
- Electroencephalogram, Epileptiform discharges, Postoperative delirium, Cardiac surgery
- Medical subject headings
- Emergence Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delirium after cardiac surgery
Postoperative evaluation delirium occurrence use the The Confusion Assessment Method(CAM) or The Confusion Assessment Method-intensive care unit(CAM-ICU).
Measured: The first day after surgery
Incidence of delirium after cardiac surgery
Postoperative evaluation delirium occurrence use the CAM or CAM-ICU.
Measured: The second day after surgery
Incidence of delirium after cardiac surgery
Postoperative evaluation delirium occurrence use the CAM or CAM-ICU.
Measured: The third day after surgery
Secondary outcomes (2)
Epileptic discharge in electroencephalogram during cardiac surgery
The electroencephalogram (EEG) was collected by Masimo instrument, and the EEG was recognized by the neuroelectrophysiologist
Measured: Awake state after entering the operating room (baseline)
Epileptic discharge in electroencephalogram during cardiac surgery
The electroencephalogram (EEG) was collected by Masimo instrument, and the EEG was recognized by the neuroelectrophysiologist
Measured: Start induction of anesthesia until leave the operating room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start1 Jul 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElectroencephalogramStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xinli Ni, doctor, Study chair, General Hospital of Ningxia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943939
- Sponsor's protocol ID
- LN 2021
- Status last verified
- Jun 2021
- First submitted
- 20 May 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Electroencephalogram Epileptiform Discharges With Postoperative Delirium During Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04943939
- Acronym / sponsor ID
- LN 2021
- Conditions
- Electroencephalogram, Postoperative Delirium
- Keywords
- Electroencephalogram, Epileptiform discharges, Postoperative delirium, Cardiac surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 29 Jun 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 purpose of this study is to explore characteristic changes of EEG epileptiform discharges in patients under CPB and correlation with POD
Detailed description
Cardiac surgery under cardiopulmonary bypass (CPB) as a result of the surgery itself great trauma and CPB this special process can lead to cerebral hypoperfusion, cerebral ischemia, increased in patients with postoperative neurological complications, the incidence of postoperative cognitive dysfunction can up to 44-53%.Postoperative delirium (POD) is not only increase the incidence of postoperative cognitive dysfunction forward, affect the quality of postoperative recovery and increased hospital costs, also associated with postoperative mortality. Although the clinical use of different drugs and technology improve the POD, but due to the mechanism is still unclear, is still lack of effective control measures. Electroencephalogram (EEG) can measure the cerebral cortex and subcortical local potential activities, to reflect the activities of the neurons in the brain. CPB can cause the abnormal vibration of brain waves, epileptiform discharges is the result of abnormal discharge of brain neurons, which is correlated with the occurrence of cognitive dysfunction.But whether EEG epileptiform discharges is related to the POD is uncertain.While epileptic seizures can be treated with anticonvulsant drugs, so the detection and treatment of early epileptic seizures may have important clinical significance for the occurrence of POD. Therefore, the main purpose of this study is to explore characteristic changes of EEG epileptiform discharges in patients under CPB and correlation with POD, offer the theoretical foundation for delirium early warning and prevention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cardiac surgery patients
Key inclusion criteria (3 listed)
- ASA II-III;
- No cognitive impairment was assessed one day before surgery;
- Patients undergoing elective CPB cardiac surgery(valvular heart surgery and coronary bypass surgery) and signed informed consent.
Key exclusion criteria (6 listed)
- Non-CPB surgery, macrovascular surgery, heart transplantation, correction of congenital heart disease;
- Stroke, schizophrenia, depression, Parkinson's disease, epilepsy or dementia;
- Inability to communicate with language impairment or major hearing or visual impairment;
- Liver function child-pugh Grade C, severe liver dysfunction;
- Severe renal insufficiency requires preoperative renal replacement therapy;
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
Incidence of delirium after cardiac surgery
Time frame: The first day after surgery
Postoperative evaluation delirium occurrence use the The Confusion Assessment Method(CAM) or The Confusion Assessment Method-intensive care unit(CAM-ICU).
Incidence of delirium after cardiac surgery
Time frame: The second day after surgery
Postoperative evaluation delirium occurrence use the CAM or CAM-ICU.
Incidence of delirium after cardiac surgery
Time frame: The third day after surgery
Postoperative evaluation delirium occurrence use the CAM or CAM-ICU.
2 secondary outcomes
Epileptic discharge in electroencephalogram during cardiac surgery
Time frame: Awake state after entering the operating room (baseline)
Epileptic discharge in electroencephalogram during cardiac surgery
Time frame: Start induction of anesthesia until leave the operating room
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
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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.
Xinli Ni, doctor study chair
General Hospital of Ningxia Medical University
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 Electroencephalogram and Postoperative Delirium, run by General Hospital of Ningxia Medical University 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 2 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinli Ni, doctor (86-951-674-3252, xinlini6@nyfy.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of delirium after cardiac surgery (time frame: The first day after surgery). The study lists 3 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 2 Nov 2021.