Cognitive DysfunctionNCT04214496
Electroencephalographic Biomarker to Predict Acute Post-operatory Cognitive Dysfunction
An observational study of Cognitive Dysfunction and Postoperative Delirium, run by University of Chile at 2 sites in Chile.
Trial summary
Acute post-operatory cognitive dysfunction states are one of the most important complications in older patients after surgery. Two acute cognitive dysfunctions have been described: postoperative delirium (PD) and postoperative subsyndromal delirium (PSSD). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Dysfunction, Postoperative Delirium
- What is being tested?
- Sedline
- Type of treatment
- Medical device
- How many people
- 106 participants
- Where
- 2 sitesChile
- Study dates
- 4 Jan 2021to 4 Aug 2022
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients at risk of delirium or subsyndromal delirium after High-risk Surgery will be evaluated in the pre and postoperative period for cognitive dysfunction and the appearance of delirium syndromes. In the intraoperative period, an EEG-based monitorization will be performed using a SedLine (Masimo, CA) Monitor.
Who may be able to join
- Age ≥ 60 years old
- Scheduled for high-risk elective surgery
- Need for at least 3 days of hospital stay
- Surgery performed under general anesthesia
- Written informed consent for participation in the trial
Who cannot join
- Patients with preoperative delirium or dementia
- Patients using neuroleptics drug during the past 6 months
- Patients with a history of encephalopathy, psychosis, stroke or brain trauma with neurologic sequels
- The use of ketamine or dexmedetomidine during surgery
- Emergency surgery
- Mechanical ventilation during the 72 after surgery
Show all 9Show fewer
- Analphabetism
- Patients who do not talk Spanish
- Patients included in another clinical trial
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
Hospital Clinico Universidad de Chile
Santiago, 8380456
Instituto Nacional del Cancer
Santiago
About this study
Official title: Electroencephalographic Biomarker to Predict the Development of Acute Post-operatory Cognitive Dysfunction States: a Protocol of an Observational Study in a Cohort of Patients From Two Centers
Acute post-operatory cognitive dysfunction states are one of the most important complications in older patients after surgery. Two acute cognitive dysfunctions have been described: postoperative delirium (PD) and postoperative subsyndromal delirium (PSSD). Patients who develop delirium, both as a complete or incomplete syndrome, have poor long-term outcomes, such as longer length of hospital stay, institutionalization at discharge, and even higher mortality, and consequently, the human and economic costs significantly increase for the health system. Here the research team will use an observational cohort, investigator blinded in two-center with a primary endpoint to validate the relative alpha power ratio as a predictive biomarker of postoperative cognitive dysfunctions.
Read the detailed description
Acute post-operatory cognitive dysfunction states are one of the most important complications in older patients after surgery. Two acute cognitive dysfunctions have been described: postoperative delirium (PD) and postoperative subsyndromal delirium (PSSD). In previous reports, the incidence of PD in older patients is between 10% to 30%, while PSSD is more frequent 30% to 50%. Patients who develop delirium, both as a complete or incomplete syndrome, have poorer long-term outcomes, such as longer length of hospital stay, institutionalization at discharge, and even higher mortality, and consequently, the human and economic costs significantly increase for the health system.
An early diagnostic and prevention of delirium are the key points to decrease the poor long-term outcomes and health costs. The diagnosis requires cognitive testing to elucidate functional patients' status before and after surgery. The need for a biomarker that may predict the occurrence of PD and PSSD and allow the selection of patients who need prevention strategies is a primary research field.
Here the research team will use an observational cohort, investigator blinded in two-center with a primary endpoint to validate the relative alpha power ratio as a predictive biomarker of postoperative cognitive dysfunctions.
To calculate the sample size, the investigators used values obtained from a previous work in a cohort of 30 patients and decided to compare the prediction ability of MoCA and alpha power ratio. ROC curves and their AUC were used to calculate the prediction ability of MoCA and alpha power ratio. Thus, a sample size of 425 patients was calculated considering an AUC of MoCA = 0.786 and AUC of alpha power = 0.895, a two-tailed test, an alpha error of 0.05 and a power of 0.8 and considering a 25% loss. Investigators consider this study as a pilot validation trial to establish the utility and the capacity of the EEG biomarker for predicting PD and PSSD, the research team aims to include the 25% of the total sample. This yields the need for 106 patients for this preliminary trial.
- Conditions
- Cognitive Dysfunction, Postoperative Delirium
- Being tested
- Sedline
- Keywords
- Delirium, Postoperative Delirium, Postoperative Subsyndromal Delirium, Biomarker
- Medical subject headings
- Cognitive Dysfunction, Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SedlineDevice
Intraoperative EEG monitorization
| Study group | Role | What they receive |
|---|---|---|
| Postoperative Delirium Risk Patients | Preoperative cognitive function testing- EEG monitorization during surgery - Postoperative function testing Receives: Device: Sedline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium and Subsyndromal Delirium
Incidence of Delirium and Subsyndromal Delirium in the cohort
Measured: 5 Postoperative days
Secondary outcomes (6)
Death
Number of deceased patients
Measured: Perioperative period
Delirium Severity
Delirium severity assessed by Cognitive Assessment Method - Severity
Measured: 5 Postoperative days
Delirium Duration
Duration of delirium during the perioperative period
Measured: Perioperative period
Need for Mechanical Ventilation assistance
Number of patients that needed mechanical ventilation
Measured: Perioperative period
Reintervention
Number of patients that needed another surgery after primary intervention
Measured: Perioperative period
Unanticipated ICU hospitalization
Number of patients that needed unanticipated intensive care unit (ICU) care
Measured: Perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start4 Jan 2021
- Primary completion4 Aug 2022
- Study completion4 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies 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
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Masimo Corporation
- Responsible party
- Principal investigator, José Ignacio Egaña Tomic, University of Chile
- Investigators
- José I. Egaña, M.D./Ph.D., Study chair, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214496
- Sponsor's protocol ID
- ID19I10345
- Status last verified
- Aug 2023
- First submitted
- 27 Dec 2019
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroencephalographic Biomarker to Predict the Development of Acute Post-operatory Cognitive Dysfunction States: a Protocol of an Observational Study in a Cohort of Patients From Two Centers
- ClinicalTrials.gov ID
- NCT04214496
- Acronym / sponsor ID
- ID19I10345
- Conditions
- Cognitive Dysfunction, Postoperative Delirium
- Keywords
- Delirium, Postoperative Delirium, Postoperative Subsyndromal Delirium, Biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Masimo Corporation
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 4 Aug 2022 (actual)
- Study completion
- 4 Aug 2022 (actual)
- First posted
- 2 Jan 2020 (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.
Acute post-operatory cognitive dysfunction states are one of the most important complications in older patients after surgery. Two acute cognitive dysfunctions have been described: postoperative delirium (PD) and postoperative subsyndromal delirium (PSSD). Patients who develop delirium, both as a complete or incomplete syndrome, have poor long-term outcomes, such as longer length of hospital stay, institutionalization at discharge, and even higher mortality, and consequently, the human and economic costs significantly increase for the health system. Here the research team will use an observational cohort, investigator blinded in two-center with a primary endpoint to validate the relative alpha power ratio as a predictive biomarker of postoperative cognitive dysfunctions.
Detailed description
Acute post-operatory cognitive dysfunction states are one of the most important complications in older patients after surgery. Two acute cognitive dysfunctions have been described: postoperative delirium (PD) and postoperative subsyndromal delirium (PSSD). In previous reports, the incidence of PD in older patients is between 10% to 30%, while PSSD is more frequent 30% to 50%. Patients who develop delirium, both as a complete or incomplete syndrome, have poorer long-term outcomes, such as longer length of hospital stay, institutionalization at discharge, and even higher mortality, and consequently, the human and economic costs significantly increase for the health system.
An early diagnostic and prevention of delirium are the key points to decrease the poor long-term outcomes and health costs. The diagnosis requires cognitive testing to elucidate functional patients' status before and after surgery. The need for a biomarker that may predict the occurrence of PD and PSSD and allow the selection of patients who need prevention strategies is a primary research field.
Here the research team will use an observational cohort, investigator blinded in two-center with a primary endpoint to validate the relative alpha power ratio as a predictive biomarker of postoperative cognitive dysfunctions.
To calculate the sample size, the investigators used values obtained from a previous work in a cohort of 30 patients and decided to compare the prediction ability of MoCA and alpha power ratio. ROC curves and their AUC were used to calculate the prediction ability of MoCA and alpha power ratio. Thus, a sample size of 425 patients was calculated considering an AUC of MoCA = 0.786 and AUC of alpha power = 0.895, a two-tailed test, an alpha error of 0.05 and a power of 0.8 and considering a 25% loss. Investigators consider this study as a pilot validation trial to establish the utility and the capacity of the EEG biomarker for predicting PD and PSSD, the research team aims to include the 25% of the total sample. This yields the need for 106 patients for this preliminary trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postoperative Delirium Risk Patients | – | Device: SedlinePreoperative cognitive function testing- EEG monitorization during surgery - Postoperative function testing |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at risk of delirium or subsyndromal delirium after High-risk Surgery will be evaluated in the pre and postoperative period for cognitive dysfunction and the appearance of delirium syndromes. In the intraoperative period, an EEG-based monitorization will be performed using a SedLine (Masimo, CA) Monitor.
Key inclusion criteria (5 listed)
- Age ≥ 60 years old
- Scheduled for high-risk elective surgery
- Need for at least 3 days of hospital stay
- Surgery performed under general anesthesia
- Written informed consent for participation in the trial
Key exclusion criteria (9 listed)
- Patients with preoperative delirium or dementia
- Patients using neuroleptics drug during the past 6 months
- Patients with a history of encephalopathy, psychosis, stroke or brain trauma with neurologic sequels
- The use of ketamine or dexmedetomidine during surgery
- Emergency surgery
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 |
|---|---|---|
| SedlineIntraoperative EEG monitorization | Device | Postoperative Delirium Risk Patients |
Primary outcome
Delirium and Subsyndromal Delirium
Time frame: 5 Postoperative days
Incidence of Delirium and Subsyndromal Delirium in the cohort
6 secondary outcomes
Death
Time frame: Perioperative period
Delirium Severity
Time frame: 5 Postoperative days
Delirium Duration
Time frame: Perioperative period
Need for Mechanical Ventilation assistance
Time frame: Perioperative period
Reintervention
Time frame: Perioperative period
Unanticipated ICU hospitalization
Time frame: Perioperative period
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 7 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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.
José I. Egaña, M.D./Ph.D. study chair
University of Chile
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 Cognitive Dysfunction and Postoperative Delirium, run by University of Chile at 2 sites in Chile.
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 9 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 7 Aug 2023. 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 Chile. 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?
Delirium and Subsyndromal Delirium (time frame: 5 Postoperative days). 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 7 Aug 2023.