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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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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