Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06318364
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-03-12
Brief Title:
Postoperative Delirium in the Post-anesthesia Care Unit
Sponsor:
Qin Zhang
Organization:
Tongji Hospital
Study Overview
Official Title:
Analysis of the Incidence and Influencing Factors of Postoperative Delirium in the Post-anesthesia Care Unit A Multicenter Observational Matched Case-control Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to investigate the incidence of postoperative delirium POD in the PACU and analyze its influencing factors in order to provide theoretical basis for early screening and intervention for high-risk POD population Blood samples of some study subjects will be collected and analyzed using molecular detection methods to provide a basis and insights into the pathophysiological mechanisms of POD
Detailed Description:
Study design type Multi-center observational case-control study based on propensity score matching The leading unit is Tongji Hospital Tongji Medical College Huazhong University of Science and Technology and the participating unit is The First Hospital of Harbin Medical University
Record general clinical information surgical-anesthesia-related information recovery indicators pain status adverse events in PACU and occurrences of postoperative delirium of all study subjects meeting the inclusion criteria of this study Based on the occurrence of postoperative delirium the subjects will be divided into delirium group and non-delirium group for univariate analysis Univariate factors with statistical significance will be included in a multiple logistic regression analysis to further identify risk factors for postoperative delirium Some selected factors can undergo ROC curve analysis to calculate the optimal cutoff value Due to the limited number of subjects experiencing postoperative delirium propensity score matching will be used to improve the statistical efficiency for analysis of risk factors for postoperative delirium Furthermore for patients with postoperative delirium a small amount of blood samples will be collected by the researchers for analysis of inflammatory factors and other components
Record general clinical information surgical-anesthesia-related information recovery indicators pain status adverse events in PACU and occurrences of postoperative delirium of all study subjects meeting the inclusion criteria of this study Based on the occurrence of postoperative delirium the subjects will be divided into delirium group and non-delirium group for univariate analysis Univariate factors with statistical significance will be included in a multiple logistic regression analysis to further identify risk factors for postoperative delirium Some selected factors can undergo ROC curve analysis to calculate the optimal cutoff value Due to the limited number of subjects experiencing postoperative delirium propensity score matching will be used to improve the statistical efficiency for analysis of risk factors for postoperative delirium Furthermore for patients with postoperative delirium a small amount of blood samples will be collected by the researchers for analysis of inflammatory factors and other components
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None