Elderly, Pathogenesis, Postoperative Complications, Postoperative Delirium (POD), Risk Prediction Model
Conditions
Keywords
postoperative delirium, elderly, Cohort study
Brief summary
The elderly patients have poorer overall conditions and have lower tolerance to trauma, anesthesia, and surgery. Therefore, the incidence of postoperative complications is relatively higher. In non-cardiac surgeries, approximately 20% of elderly patients experience postoperative complications, and the incidence of postoperative delirium (POD) is 23.8%. This may lead to prolonged hospital stays, increased hospital costs, and affect prognosis and even mortality. The investigators plan to conduct a prospective cohort study by systematically collecting biological samples and clinical information of elderly patients during the perioperative period to explore the possible risk factors and pathogenesis of postoperative delirium and postoperative complications in elderly surgical patients, and to construct a risk prediction model for postoperative complications.
Interventions
None listed
Sponsors
Second Affiliated Hospital of Wenzhou Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1\) Surgical patients aged 65 or above or non-surgical subjects aged 65 or above. 2) Agree to participate in this study and sign the informed consent form.
Exclusion criteria
1）Refused to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative delirium (POD) within 7 days after surgery | Preoperative, during the first 7 postoperative days | POD is diagnosed daily using the Three-Minute Diagnostic Confusion Assessment Method (3D-CAM). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The types of postoperative delirium | Preoperative, during the first 7 postoperative days | The type of delirium is assessed using the Richmond Agitation-Sedation Scale (RASS). The Richmond Agitation-Sedation Scale (RASS) is a 10-point scale ranging from -5 (unarousable) to +4 (combative). A score of +4 represents a combative state where the patient is violent and poses immediate danger, while a score of -5 indicates no response to any stimulus. Based on the RASS score, delirium can be categorized into three motoric subtypes: Hyperactive delirium: RASS scores consistently between +1 and +4. Hypoactive delirium: RASS scores consistently between 0 and -3. Mixed-type delirium: RASS scores that fluctuate between positive and negative values over the observation period. |
| The severity of postoperative delirium | Preoperative, during the first 7 postoperative days | The severity of postoperative delirium will be assessed using the Confusion Assessment Method-Severity scale (CAM-S). |
| The duration of postoperative delirium | Preoperative, during the first 7 postoperative days | Duration is defined as the number of days from the onset of delirium symptoms to symptom resolution or hospital discharge, whichever occurs first. |
| Postoperative neurocognitive dysfunction | preoperative baseline, within 7 days postoperatively, and at 1, 6, and 12 months postoperatively. | Neurocognitive decline is assessed by comparing baseline to postoperative scores on: Mini-Mental State Examination (MMSE, 0-30, higher=better function), Montreal Cognitive Assessment (MoCA, 0-30, higher=better function); and five neuropsychological tests-Clock Drawing Test, (DST, 0-16, higher=better attention), Trail Making Test Parts A and B (TMT-A/B, seconds, lower=better), Boston Naming Test (BNT, 0-30, higher=better naming), Auditory Verbal Learning Test - Huashan version (AVLT-H delayed recall, 0-10, higher=better memory), and Clock Drawing Test (CDT, 0-10, higher=better visuospatial/executive function). Patient/caregiver reports are also collected. |
| Acute pain | Preoperative and 3 days postoperative. | Using Visual Analogue Scale (VAS), 0-100, 0 means no pain, 100 means severe pain |
| Hospital Anxiety and Depression Scale (HADS) score | preoperative, 5 days, 1 month, 6 months, and 1 year postoperative. | The Hospital Anxiety and Depression Scale (HADS) is used for assessment, with each subscale (anxiety or depression) scored from 0-21: "0-7: Non-case", "8-10: Doubtful case", "11-21: Definite case". Higher scores clearly indicate worse outcomes, i.e., more severe anxiety or depression symptoms. |
| Activity of Daily Living | preoperative, 5 days, 1 month, 6 months, and 1 year postoperative. | The Activities of Daily Living (ADL) are typically assessed using the Barthel Index. 0-100. A higher score indicates stronger independence: a score of 100 represents complete independence; a score of 61-99 suggests mild functional impairment with basic self-care ability; and a score of ≤40 indicates severe functional impairment, with significant or complete reliance on others for daily living. |
| Sleep quality | preoperative, 5 days, 1 month, 6 months, and 1 year postoperative. | Sleep quality is assessed using the Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 to 21 points. A score greater than 7 (\>7) is typically considered the clinical cutoff for poor sleep quality. A higher score indicates poorer sleep quality. |
| The FRAIL Scale | preoperative, 5 days, 1 month, 6 months, and 1 year postoperative. | The FRAIL (Fatigue, Resistance, Ambulation, Illnesses, and Loss of Weight) Scale ranges from 0 to 5. A score of 0 indicates robust/non-frail status, scores of 1-2 indicate pre-frail status, and scores of 3-5 indicate frail status. |
| Quality of Life Score | preoperative, 1 month, 6 months, and 1 year postoperative. | using EQ-5D(Score of EuroQol Five Dimensions Questionnaire (EQ-5D)) to measure quality of life |
| Mortality | During hospitalization, 1 month, 6 months, and 1 year postoperative. | In-hospital mortality; 30-day postoperative mortality; 1-year postoperative mortality |
| Length of hospitalization | till the day of discharge from hospital, an average of 7 days | Length of hospital stay are measured from the anesthesia starting day to the discharge day |
| Days at home up to 30 days after surgery (DAH30) | up to 30 days after surgery | — |
| Economic indicators | during the entire trial, an average of 1 year. | Hospitalization fees; -Preoperative fees; -Anesthesia fees; -Surgery fees; -Post-operative fees; -Post-discharge medical expenses. |
Countries
China
Contacts
CONTACTTing Li MD. PhD
PRINCIPAL_INVESTIGATORTing Li, MD. PhD
Department of Anaesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
Outcome results
None listed