Protocol for a Single-Centre Prospective Observational Study of Postoperative Delirium Following Total Joint Arthroplasties Among South East Asians
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Singapore General Hospital
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Post operative delirium incidence
Study Overview
Brief Summary
The incidence of post-operative delirium in the South-east Asian population is not known. Through a prospective, single centre, observational study, the investigators aim to characterize the incidence and risk factors of delirium in older adults undergoing elective total joint arthroplasties (TJA). The study will recruit eligible patients (65 - 90 years old undergoing elective TJA), with a targeted sample size of 500. Patients will be screened for dementia and Confusion Assessment Method (CAM) scores obtained pre and post operatively. Other data such as preoperative Charlson comorbidity index (CCI), post op complications using Post operative Morbidity Survey (POMS), pain scores, readmission rates and length of hospital stay (LOS), functional and health-related quality-of-life (HRQoL) will also be collected and analysed.
Detailed Description
BACKGROUND
Modern studies have evaluated the risk factors and incidence of postoperative delirium in post-TJA patients. In current literature, incidence ranges from 0-10%. However, the epidemiology of these studies mainly focused on non-Asian populations. The investigators hope to determine both the incidence and risk factors of postoperative delirium in patients undergoing TJA with a focus on the Asian population. This is especially relevant in today's ageing Asian population.
AIMS
To characterize the incidence and risk factors of delirium in older adults undergoing elective total joint replacement surgery.
HYPOTHESIS
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 65 Years to 90 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients undergoing elective total knee or total hip arthroplasty
Exclusion Criteria
- •Patients who are deemed to lack mental capacity to give consent.
Outcomes
Primary Outcomes
Post operative delirium incidence
Time Frame: Up to 30 days
Measured using confusion assessment method (CAM) tool
Secondary Outcomes
- incidence of post operative nausea and vomiting (PONV)(post op day 1)
- Post operative complications(Up to 30 days post operatively)
- functional and health-related quality-of-life (HRQoL)(6 months , 12 months)
- Days Alive and Out of Hospital (DAOH)(1 month, 6 months, 12 months)
- Length of hospital stay(up to 12 months)
- Hospital readmission rate(30 days post operative)