Protocol for Observational Study of Post op Delirium Following Total Joint Arthroplasties
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| ClinicalTrials.gov Identifier: NCT03260218 |
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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
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Sponsor:
Singapore General Hospital
Information provided by (Responsible Party):
Singapore General Hospital
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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 |
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| Postoperative Delirium |
Show Detailed Description
| 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 |
Primary Outcome Measures :
- Post operative delirium incidence [ Time Frame: Up to 30 days ]Measured using confusion assessment method (CAM) tool
Secondary Outcome Measures :
- Post operative complications [ Time Frame: Up to 30 days post operatively ]measured using post operative morbidity survey (POMS)
- incidence of post operative nausea and vomiting (PONV) [ Time Frame: post op day 1 ]the total number of patients experiencing PONV
- Length of hospital stay [ Time Frame: up to 12 months ]the total number of days stayed in hospital during this elective admission
- Hospital readmission rate [ Time Frame: 30 days post operative ]the percentage of patients being readmitted for a complication related to the surgery
- 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
- 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
| Contact: Hairil Abdullah, MBBS | 63265519 | hairil.rizal.abdullah@singhealth.com | |
| Contact: Hairil Rizal Abdullah, MBBS | 63265519 | hairil.rizal.abdullah@singhealth.com |
Locations
| 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):
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Singapore General Hospital:
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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 |