FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/02/062931 [Registered on: 21/02/2024] Trial Registered Prospectively
Last Modified On: 20/02/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Efficacy of brief preoperative cognitive screening using animal fluency test and six-item screener for prediction of postoperative delirium in elderly undergoing orthopedic surgery; a prospective observational study 
Scientific Title of Study   Efficacy of brief preoperative cognitive screening using animal fluency test and six-item screener for prediction of postoperative delirium in elderly undergoing orthopedic surgery; a prospective observational study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sukhyanti Kerai 
Designation  Associate Professor  
Affiliation  Loknayak hospital, Maulana Azad Medical College  
Address  Room no 413, B L Taneja Block, Department of Anaesthesiology, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi
Department of Anaesthesiology, Maulana azad medical college and associated loknayak hospital, New Delhi
New Delhi
DELHI
110002
India 
Phone  9968527122  
Fax    
Email  drsukhi25@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sukhyanti Kerai 
Designation  Associate Professor  
Affiliation  Loknayak hospital, Maulana Azad Medical College  
Address  Room no 413, B L Taneja Block, Department of Anaesthesiology, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi
Department of Anaesthesiology, Maulana azad medical college and associated loknayak hospital, New Delhi
New Delhi
DELHI
110002
India 
Phone  9968527122  
Fax    
Email  drsukhi25@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sukhyanti Kerai 
Designation  Associate Professor  
Affiliation  Loknayak hospital, Maulana Azad Medical College  
Address  Room no 413, B L Taneja Block, Department of Anaesthesiology, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi
Department of Anaesthesiology, Maulana azad medical college and associated loknayak hospital, New Delhi
New Delhi
DELHI
110002
India 
Phone  9968527122  
Fax    
Email  drsukhi25@gmail.com  
 
Source of Monetary or Material Support  
Loknayak Hospital, Maulana Azad Medical College, New Delhi.  
 
Primary Sponsor  
Name  Loknayak hospital  
Address  Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi. 
Type of Sponsor  Government 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 Sukhyanti Kerai  Loknayak Hospital   OT 2, 2nd floor, Loknayak Hospital, Maulana Azad Medical College
New Delhi
DELHI 
9968527122

drsukhi25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
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  65.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. duration of at least 2 hours
2. American Society of Anesthesiologists (ASA) physical status I, II and III
3. Patients requiring postoperative stay for at least 72 hours  
 
ExclusionCriteria 
Details  1. Unable to speak and understand Hindi language 2. Hearing (unaided)or speaking impairment
3. Altered mental status  
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Primary outcome: Sensitivity, specificity, and predictive value of AFT and 6-IS for postoperative delirium.   The patients will be screened on postoperative day 3 using the Confusion Assessment method. 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome: Odd ratio of demographic characteristics for postoperative delirium.  The patients will be screened on postoperative day 3 using the Confusion Assessment method. 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "162"
Final Enrollment numbers achieved (India)="162" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/02/2024 
Date of Study Completion (India) 01/03/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drsukhi25@gmail.com].

  6. For how long will this data be available start date provided 07-11-2025 and end date provided 07-02-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Baseline cognitive impairment is one of the most significant risk factors for the development of postoperative delirium and neurocognitive disorders in older adults. Preexisting cognitive impairment is both a risk factor and a predictor and/or modifier of postoperative outcomes. Despite this preoperative cognitive screening is inconsistently performed in elderly surgical patients. 
 Most of the standard bedside screening tests are too time-consuming to be practical in a preoperative evaluation clinic, where daily visit volume is high, and each patient often needs evaluation of multiple organ systems. The challenge, therefore, is to identify a cognitive assessment instrument that is brief, easily administered, and scored. Also, the performance on many of the tests is known to be affected by the education level (not suitable for those who are illiterate or those with low levels of literacy). Hence, there is a need for the exploration of alternative cognitive screening tests for Indian older surgical patients. 
We wish to conduct a prospective observational study to assess the association of preoperative cognitive screening tests for predicting postoperative delirium in elderly surgical patients with the primary objective to evaluate and compare the association of animal fluency test and six-item screener with postoperative delirium in patients undergoing lower limb orthopedic surgery and secondary objective to assess the association of baseline characteristics of patients (age, comorbidities, literacy, socio-economic class, etc) with postoperative delirium. 153 patients ≥65 years of age, ASA I and II, presenting for lower limb orthopedic surgery with a duration of at least 2 hours, requiring postoperative stay for at least 72 hours will be included. Those who are unable to speak and understand the Hindi language, have hearing or speaking impairment, or have pre-existing neurological status such as altered mental status, or dementia will be excluded. The cognitive screening will be administered one day before the scheduled surgery during the preanaesthetic visit. The patients will be screened on postoperative day 3 using the Confusion Assessment method.
AFT requires patients to name as many animals as possible within 60 sec, with one point given for each unique animal. Scores< 15 points have demonstrated high sensitivity and specificity (88% and 96%, respectively) for Alzheimer’s dementia in the memory clinic setting. This requires adequate memory as well as effective executive functions. Six-item screener is a simple cognitive screening test consisting of a 3-item recall and a 3-item temporal orientation (day of the week, month, year). Each correct response earns 1 point for a total of 6 points. Administration time is 1 minute, not including the delay for the recall component. 
 
Close