The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Location status: Recruiting
NCT Number: NCT07314762
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.
Interested in participating?
Request Info65 year and older
All sexes
Observational
Wenzhou, Zhejiang, 325000, China
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1)Refused to participate in the study.
Time frame: Preoperative, during the first 7 postoperative days
POD is diagnosed daily using the Three-Minute Diagnostic Confusion Assessment Method (3D-CAM).
Time frame: 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.
Time frame: Preoperative, during the first 7 postoperative days
The severity of postoperative delirium will be assessed using the Confusion Assessment Method-Severity scale (CAM-S).
Time frame: 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.
Time frame: 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.
Time frame: Preoperative and 3 days postoperative.
Using Visual Analogue Scale (VAS), 0-100, 0 means no pain, 100 means severe pain
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: During hospitalization, 1 month, 6 months, and 1 year postoperative.
In-hospital mortality; 30-day postoperative mortality; 1-year postoperative mortality
Time frame: 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
Time frame: up to 30 days after surgery
Time frame: during the entire trial, an average of 1 year.
Hospitalization fees; -Preoperative fees; -Anesthesia fees; -Surgery fees; -Post-operative fees; -Post-discharge medical expenses.
Contact information is provided by the study sponsor or research team.
Second Affiliated Hospital of Wenzhou Medical University
Other
Elderly Patients Undergoing Surgery During Perioperative Period: a Prospective Cohort Study
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