| 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
|
|
|
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
|
|
|
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 |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
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Blinding/Masking
|
|
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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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol
- 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.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drsukhi25@gmail.com].
- 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.
- 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. |