Protocol for a single-centre prospective observational study of postoperative delirium following total joint arthroplasties among South East Asians

东南亚人群全关节置换术后谵妄的单中心前瞻性观察研究方案

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Abstract

INTRODUCTION: Postoperative delirium is a serious and common complication in older adults following total joint arthroplasties (TJA). It is associated with increased risk of postoperative complications, mortality, length of hospital stay and postdischarge institutionalisation. Thus, it has a negative impact on the health-related quality of life of the patient and poses a large economic burden. This study aims to characterise the incidence of postoperative delirium following TJA in the South East Asian population and investigate any risk factors or associated outcomes. METHODS AND ANALYSIS: This is a single-centre prospective observational study recruiting patients between 65 and 90 years old undergoing elective total knee arthroplasty or total hip arthroplasty. Exclusion criteria included patients with clinically diagnosed dementia. Preoperative and intraoperative data will be obtained prospectively. The primary outcome will be the presence of postoperative delirium assessed using the Confusion Assessment Method on postoperative days 1, 2 and 3 and day of discharge. Other secondary outcomes assessed postoperatively will include hospital outcomes, pain at rest, knee and hip function, health-related quality of life and Postoperative Morbidity Survey-defined morbidity. Data will be analysed to calculate the incidence of postoperative delirium. Potential risk factors and any associated outcomes of postoperative delirium will also be determined. ETHICS AND DISSEMINATION: This study has been approved by the Singapore General Hospital Institutional Review Board (SGH IRB) (CIRB Ref: 2017/2467) and is registered on the ClinicalTrials.gov registry (Identified: NCT03260218). An informed consent form will be signed by all participants before recruitment and translators will be made available to non-English-speaking participants. The results of this study will be presented at international conferences and submitted to a peer-reviewed journal. The data collected will also be made available in a public data repository. TRIAL REGISTRATION NUMBER: NCT03260218.

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