| CTRI Number |
CTRI/2024/11/076403 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
07/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Use of artificial intelligence for pre operative evaluation |
|
Scientific Title of Study
|
Use of chatbot to assist pre operative assessment-A feasibility 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 Zubair Mohamed |
| Designation |
Associate Professor |
| Affiliation |
Amrita Institute of Medical Sciences,Kochi |
| Address |
Department of Anesthesiology,
Amrita Institute of Medical Sciences, Kochi
Ernakulam
KERALA
682041
India |
| Phone |
04842856162 |
| Fax |
04842802020 |
| Email |
zubairumer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Zubair Mohamed |
| Designation |
Associate Professor |
| Affiliation |
Amrita Institute of Medical Sciences,Kochi |
| Address |
Department of Anesthesiology,
Amrita Institute of Medical Sciences, Kochi
Ernakulam
KERALA
682041
India |
| Phone |
04842856162 |
| Fax |
04842802020 |
| Email |
zubairumer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikita Saji |
| Designation |
PGT 1st year |
| Affiliation |
Amrita Institute of Medical Sciences,Kochi |
| Address |
Department of Anesthesiology,
Amrita Institute of Medical Sciences,
Kochi
Ernakulam
KERALA
682041
India |
| Phone |
04842856162 |
| Fax |
04842802020 |
| Email |
nikitasaji96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Science,Kochi |
|
|
Primary Sponsor
|
| Name |
Amrita Institute of Medical Sciences |
| Address |
AIMS, Ponnekara P.O, Kochi, Kerala,682041 |
| 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 Zubair Mohamed |
Amrita Institute of Medical Sciences. |
6/1,first floor
Department of Anesthesiology
Division:Perioperative care
Ernakulam
KERALA |
04842856162
04842802020
zubairumer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Amrita School of Medicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z139||Encounter for screening, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Anesthetist |
Will work in clinic as usual |
| Intervention |
Chatbot |
A chatbot will supplement the work of anaesthetist at clinic and chatbot will be used only once during preoperative assesssment and will take less than half an hour. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients undergoing elective surgery
2)Patients who have accessibility to smart phones
3)Patients comfortable in English language. |
|
| ExclusionCriteria |
| Details |
1)Age less than 18 years and above 60 years
2)Patients undergoing emergency surgery
3)Patients who do not have accessibility to smart phones
4)Patients who are not comfortable in English language |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the feasibility of chatbot in preanaesthetic clinic in tertiary care set up
|
End of preanesthetic evaluation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-To know the acceptability of the use of chatbot in preanaesthetic clinic among
patients.
-To know the acceptability of use of chatbot in preanaesthetic clinic among
treating professionals |
End of preanesthetic evaluation |
|
|
Target Sample Size
|
Total Sample Size="212"
Sample Size from India="212"
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)
|
18/11/2024 |
| 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 Yet Recruiting |
| 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
|
It is a randomised cross-over trial consisting of two phases. In preclinical phase,a set of questionnaires will be designed. Then, a chatbot, integrated with a Large Language Model will be developed using the questionnaire. This questionnaire, accessed via a QR code will be circulated among practicing anesthetists. In clinical phase,they were randomized to two groups. In Group C, the assessment was first done via the chatbot followed by anaesthetist(Human).In Group H, the assessment is first done by anaesthetist and then by the chatbot.Patients access the chatbot via a QR code and their responses will be analysed.Immediate summary of the responses will be made available to the patient and the anaesthetist. This summary will subsequently be used to conduct focussed PAC evaluation and examination. |