| CTRI Number |
CTRI/2024/04/065364 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
03/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To find the proportion of elderly patients undergoing lower limb orthopedic surgeries developing post-operative delirium and to test the use of a novel risk assessment tool for predicting delirium. |
|
Scientific Title of Study
|
Proportion of Postoperative Delirium(POD) in Elderly Orthopedic Patients and Use of the PROPDESC Risk Assessment Tool to Predict POD. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gowri P M |
| Designation |
PG Resident |
| Affiliation |
Believers Church Medical College Hospital |
| Address |
Department of Anaesthesiology
Believers Church Medical College Hospital,St Thomas Nagar, Kuttapuzha PO, Thiruvalla
Pathanamthitta KERALA 689103 India |
| Phone |
09482655100 |
| Fax |
|
| Email |
gowrimurali96@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ashu Sara Mathai |
| Designation |
Professor and HOD |
| Affiliation |
Believers Church Medical College Hospital |
| Address |
Department of Anaesthesiology, Believers Church Medical College Hospital, St Thomas Nagar, Kuttapuzha, Thiruvalla
Pathanamthitta KERALA 689103 India |
| Phone |
09888500240 |
| Fax |
|
| Email |
ashumathai@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Gowri P M |
| Designation |
PG Resident |
| Affiliation |
Believers Church Medical College Hospital |
| Address |
Department of Anaesthesiology, Believers Church Medical College Hospital, St Thomas Nagar, Kuttapuzha, Thiruvalla
Pathanamthitta KERALA 689103 India |
| Phone |
09482655100 |
| Fax |
|
| Email |
gowrimurali96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Believers Church Medical College Hospital, St Thomas Nagar, Kuttapuzha PO, Thiruvalla 689103 |
|
|
Primary Sponsor
|
| Name |
Believers Church Medical College Hospital |
| Address |
St Thomas Nagar ,Kuttapuzha, Thiruvalla, Kerala- 689103 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashu Sara Mathai |
Believers Church Medical College Hospital |
Department of Anaesthesiology, St Thomas Nagar, Kuttapuzha
Thiruvalla, Kerala 689104 Pathanamthitta KERALA |
9888500240
ashumathai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Believers Church Medical College Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged above 60 years undergoing elective orthopaedic lower limb surgeries
ASA(PS)1-3
Duration of surgery less than 240 minutes or 4 hours |
|
| ExclusionCriteria |
| Details |
Emergency procedures
Pre-existing dementia, delirium or disorders of consciousness or any neurological disorders which prevent adequate cognitive testing and delirium assessment.
Post-operative requirement of ICU or HDU care/ ventilatory support/ any form of sedation.
Language barriers
Had undergone surgery in the past 3 months.
Patient refusal to participate. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Proportion of Post-operative delirium among elderly patients undergoing elective lower limb surgeries.
2.What is the effectiveness of the pre-operative PROPDESC tool in predicting post-operative delirium in elderly patients undergoing elective lower limb surgeries.
3. To explore association of risk factors in elderly undergoing elective lower limb orthopaedic surgeries. |
18 months for studying proportion of post-operative delirium in elderly patients undergoing elective lower limb surgeries. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of outcomes, post-operative complications, length of hospital stay and cost of treatment between patients who developed delirium versus those who did not. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Post-operative delirium (POD) is a common complication of elderly patients with reported incidence ranging from 15% to 50%. It is associated with adverse outcomes, including longer length of hospital stay, decline in function and cognition, increased risk of nursing home placement, and death. Patients older than 70 years of age with hip fractures have more than threefold increased risk of developing POD and the hypoactive subtype is more likely to develop in people over the age of 80 . Screening tools for predicting risk of POD should consider ease of implementation in a busy preoperative setting. The MoCA(Montreal Cognitive Assessment), the MMSE(Mini Mental State Examination) and mini-Cog tests have been studied in the peri-operative setting for assessment of cognition. However, the latter two are more time consuming and not freely available for use. Most commonly reported tools for the diagnosis of POD include CAM score, 4AT, besides other tools like Delirium detection scale(DDS). Limited Indian data exist on the incidence of POD. The aim of this study is to find the proportion of patients developing post-operative delirium among those undergoing elective orthopaedic lower limb surgeries and the effectiveness of a risk assessment tool PROPDESC to predict development of post- operative delirium in such patients. This will help identify at risk patients and therefore modify peri-operative management. Study tools used- PRe-Operative Prediction of post-operative DElirium by appropriate SCreening( PROPDESC), Montreal Cognitive Assessment (MoCA), Confusion Assessment Method(CAM). All the patients meeting the inclusion and exclusion criteria will be enrolled. On the day before surgery, Informed consent for delirium assessment will be obtained. In addition to the routine Pre-Anaesthetic evaluation, the PROPDESC score will be calculated using Age, ASA Classification, NYHA Classification, Surgical risk and Montreal Cognitive Assessment (MoCA) Intraoperatively, the type and duration of surgery and of anaesthesia, as well as intra-operative complications, if any, will be noted. Postoperatively, patients will be interviewed with CAM-Sand 4AT on postoperative days 1, 3 and 5. Patients with at least one postoperative interview will be included in the analysis. Outcome parameters noted will include, occurrence of any post-operative complications, length of hospital stay and death/ discharge. Total costs of hospitalisation will also be
noted.
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