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| Name | Class |
|---|---|
| Instituto Nacional del Cancer, Chile | UNKNOWN |
| Pontificia Universidad Catolica de Chile | OTHER |
| Hospital Base San Jose Osorno | UNKNOWN |
| Clinica Santa Maria |
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Acute post-operatory cognitive dysfunction states are one of the most important complications in older patients that underwent surgery. Among them postoperative delirium (POD) is the the most studied. Patients who develop delirium 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. Here the research team will use an observational cohort, investigator blinded in five-center with a primary endpoint to validate intraoperative EEG analysis as a reliable biomarker of postoperative delirium.
Acute post-operatory cognitive dysfunction states are one of the most frequent complications in older patients after surgery, being POD the most important. Previous studies have shown than the incidence of POD in older patients range between 10-50%. Patients who develop POD have poorer long-term outcomes, such as longer length of hospital stay, institutionalization at discharge, and even higher mortality. Consequently, the human and economic costs associated to POD represents an important issue for health systems worldwide.
A key element to diminish POD and its burden on healthcare is early diagnostic. Current risk assessment tools are centered on clinical approaches based on cognitive tests (i.e., MoCA) and/or prediction models that uses patients' clinical variables (i.e., DELPHI score). We have developed a strategy that uses intraoperative EEG features as building blocks for a new POD risk assessment predictive model. This system, called PEUMA, uses data obtained from 95 patients from a previous study (NCT04214496).
This will be a multicenter (five-centers), observational study and its primary outcome will be PEUMA's ability to predict POD.
To calculate the sample size, the methodology described by Riley et al was used. This method is specially designed for clinical prediction models. Such a tool is available online (https://mvansmeden.shinyapps.io/BeyondEPV/). The parameters used were the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients at risk of developing POD |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POD risk estimation using PEUMA | Diagnostic Test | A software will analyze intraoperative EEG recording for the estimation of a POD Risk Index |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Delirium | Incidence of POD in the cohort diagnosed using the Confusion Assessment Method (CAM) twice/day | First 3 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Death | Number of deceased patients | 30 days after surgery |
| Delirium Severity | Delirium severity assessed by Cognitive Assessment Method - Severity (CAM-S) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients at risk of developing POD will be evaluated in the pre and postoperative period for cognitive dysfunction and the appearance of POD. In the intraoperative period, an EEG-based monitorization will be performed using a SedLine (Masimo, CA) Monitor.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinico Universidad de Chile | Santiago | Santiago Metropolitan | 8380456 | Chile | ||
| Instituto Nacional del Cancer |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32188600 | Result | Riley RD, Ensor J, Snell KIE, Harrell FE Jr, Martin GP, Reitsma JB, Moons KGM, Collins G, van Smeden M. Calculating the sample size required for developing a clinical prediction model. BMJ. 2020 Mar 18;368:m441. doi: 10.1136/bmj.m441. No abstract available. | |
| 31680886 | Result | Gutierrez R, Egana JI, Saez I, Reyes F, Briceno C, Venegas M, Lavado I, Penna A. Intraoperative Low Alpha Power in the Electroencephalogram Is Associated With Postoperative Subsyndromal Delirium. Front Syst Neurosci. 2019 Oct 18;13:56. doi: 10.3389/fnsys.2019.00056. eCollection 2019. |
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Individual participant data might be shared with other researchers only if participants give written consent for that.
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| OTHER |
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| First 3 days after surgery |
| Delirium Duration | Duration of delirium during the postoperative period | First 3 days after surgery |
| Need for Mechanical Ventilation | Number of patients that needed mechanical ventilation | First 3 days after surgery |
| Reintervention | Number of patients who required other unanticipated surgery after the primary intervention | First 3 days after surgery |
| Unanticipated ICU hospitalization | Number of patients that needed unanticipated intensive care unit (ICU) care | First 3 days after surgery |
| Santiago |
| Santiago Metropolitan |
| Chile |
| 35396283 | Result | Wong CK, van Munster BC, Hatseras A, Huis In 't Veld E, van Leeuwen BL, de Rooij SE, Pleijhuis RG. Head-to-head comparison of 14 prediction models for postoperative delirium in elderly non-ICU patients: an external validation study. BMJ Open. 2022 Apr 8;12(4):e054023. doi: 10.1136/bmjopen-2021-054023. |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |