Protocol for Observational Study of Post op Delirium Following Total Joint Arthroplasties
Protocol for a Single-Centre Prospective Observational Study of Postoperative Delirium Following Total Joint Arthroplasties Among South East Asians
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 3, 2017
CompletedFirst Submitted
Initial submission to the registry
August 18, 2017
CompletedFirst Posted
Study publicly available on registry
August 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedAugust 31, 2017
August 1, 2017
6 months
August 18, 2017
August 29, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post operative delirium incidence
Measured using confusion assessment method (CAM) tool
Up to 30 days
Secondary Outcomes (6)
Post operative complications
Up to 30 days post operatively
incidence of post operative nausea and vomiting (PONV)
post op day 1
Length of hospital stay
up to 12 months
Hospital readmission rate
30 days post operative
functional and health-related quality-of-life (HRQoL)
6 months , 12 months
- +1 more secondary outcomes
Eligibility Criteria
Patients aged between 65 and 90 undergoing elective total joint (hip or knee) replacement surgery in Singapore General Hospital
You may qualify if:
- Patients undergoing elective total knee or total hip arthroplasty
You may not qualify if:
- Patients who are deemed to lack mental capacity to give consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Singapore General Hospital
Singapore, 169608, Singapore
Related Publications (1)
Abdullah HR, Tan SR, Lee SJ, Bin Abd Razak HR, Seet RH, Ying H, Sethi E, Sim EY. Protocol for a single-centre prospective observational study of postoperative delirium following total joint arthroplasties among South East Asians. BMJ Open. 2018 Mar 6;8(3):e019426. doi: 10.1136/bmjopen-2017-019426.
PMID: 29511014DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2017
First Posted
August 24, 2017
Study Start
July 3, 2017
Primary Completion
December 31, 2017
Study Completion
December 31, 2017
Last Updated
August 31, 2017
Record last verified: 2017-08