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Protocol for Observational Study of Post op Delirium Following Total Joint Arthroplasties

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ClinicalTrials.gov Identifier: NCT03260218
Recruitment Status : Unknown
Verified August 2017 by Singapore General Hospital.
Recruitment status was:  Recruiting
First Posted : August 24, 2017
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
Singapore General Hospital

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.

Condition or disease
Postoperative Delirium

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Protocol for a Single-Centre Prospective Observational Study of Postoperative Delirium Following Total Joint Arthroplasties Among South East Asians
Actual Study Start Date : July 3, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium




Primary Outcome Measures :
  1. Post operative delirium incidence [ Time Frame: Up to 30 days ]
    Measured using confusion assessment method (CAM) tool


Secondary Outcome Measures :
  1. Post operative complications [ Time Frame: Up to 30 days post operatively ]
    measured using post operative morbidity survey (POMS)

  2. incidence of post operative nausea and vomiting (PONV) [ Time Frame: post op day 1 ]
    the total number of patients experiencing PONV

  3. Length of hospital stay [ Time Frame: up to 12 months ]
    the total number of days stayed in hospital during this elective admission

  4. Hospital readmission rate [ Time Frame: 30 days post operative ]
    the percentage of patients being readmitted for a complication related to the surgery

  5. functional and health-related quality-of-life (HRQoL) [ Time Frame: 6 months , 12 months ]
    tools used to assess knee function, ADL status, emotional and social wellbeing

  6. Days Alive and Out of Hospital (DAOH) [ Time Frame: 1 month, 6 months, 12 months ]
    measures the death rate and total summation of days spent outside of hospital following the surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients aged between 65 and 90 undergoing elective total joint (hip or knee) replacement surgery in Singapore General Hospital
Criteria

Inclusion Criteria:

  • Patients undergoing elective total knee or total hip arthroplasty

Exclusion Criteria:

  • Patients who are deemed to lack mental capacity to give consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03260218


Contacts
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Contact: Hairil Abdullah, MBBS 63265519 hairil.rizal.abdullah@singhealth.com
Contact: Hairil Rizal Abdullah, MBBS 63265519 hairil.rizal.abdullah@singhealth.com

Locations
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Singapore
Singapore General Hospital Recruiting
Singapore, Singapore, 169608
Principal Investigator: Hairil Rizal Abdullah, MBBS         
Sub-Investigator: Hamid Razak, MBBS         
Sub-Investigator: Eileen Sim, MBBS         
Sub-Investigator: Si Jia Lee, MBBS         
Sub-Investigator: Rachel Seet, MBBS         
Sub-Investigator: Ervin Sethi, MBBS         
Sponsors and Collaborators
Singapore General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT03260218     History of Changes
Other Study ID Numbers: TJA2017
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Singapore General Hospital:
postoperative delirium
elderly
total joint replacement
risk factors for delirium
postoperative confusion
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders