| CTRI Number |
CTRI/2022/11/047193 [Registered on: 10/11/2022] Trial Registered Prospectively |
| Last Modified On: |
09/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Review of the Effectiveness of Telemedicine for
Pre-anaesthetic Check-ups in children having Elective Surgery
|
|
Scientific Title of Study
|
Evaluation of the Efficacy of Telemedicine for
Pre-anaesthetic Check-up in Paediatric Patients Undergoing Elective Surgery
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yukti Shah |
| Designation |
post graduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
BL Taneja Block, 3rd floor, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9810224311 |
| Fax |
|
| Email |
yuktishah95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelam Prasad |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
BL Taneja Block, 3rd floor, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9968604372 |
| Fax |
|
| Email |
nprasadgovil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Yukti Shah |
| Designation |
post graduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
BL Taneja Block, 3rd floor, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9810224311 |
| Fax |
|
| Email |
yuktishah95@gmail.com |
|
|
Source of Monetary or Material Support
|
| LOK NAYAK HOSPITAL, Jawaharlal Nehru Marg, near Delhi Gate, New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
JLN Marg, New Delhi, 110002 |
| 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 |
| Yukti Shah |
Lok Nayak Hospital |
Maulana Azad Medical College,
JLN Marg, New Delhi-110002
Central
DELHI |
9810224311
yuktishah95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Maulana Azad Medical College |
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 |
| Comparator Agent |
GROUP C - Conventional PAC |
Group C patients (35 patients) will go to routine Pre-anaesthetic clinic for clearance. Number of visits to the clinic and duration required for preliminary anaesthesia clearance will be recorded. |
| Intervention |
Group T- TELEMEDICINE |
Group T patients (35 patients) will undergo pre-anaesthetic checkup via video calls. Pre-anaesthesia assessment questionnaire in which details of patient identification, hospital registration, photographs of all vital parameters, detailed medical and treatment history, investigations and airway examination will be assessed on Zoom Cloud Meeting application till the patient gets primary PAC clearance. Once they get clearance, they can proceed to take a date for surgery. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Parents/Guardians who have access to any of the devices like smart phone, computer with camera, tablet.
2.Children or Guardians who are able to read and write.
|
|
| ExclusionCriteria |
| Details |
1.Auditory impairment in the child or guardian
2.Children or guardians who do not speak local language Hindi/English.
3.Psychological disorder in the child or guardian
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of visits/video calls required to get preliminary anaesthesia clearance and delay of surgery. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Rate of cancellation of surgery
2.Concordance of pre-anaesthetic checkup, airway examination finding of visiting anesthesiologist(A2) with preliminary pre-anaesthetic evaluation (On the day of admission) using concordance scale
3.Time required for each consultation.
4.Parents/Guardian satisfaction using 5-point Likert scale on preliminary PAC clearance.
|
12 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
30/11/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Suspended |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomised comparative study in which we will be comparing the efficacy of telemedicine
with in-person pre-anaesthetic evaluation for paediatric patients of age 3-12 years undergoing
elective surgery. We will be assessing the
number of visits/video calls required to get preliminary anaesthesia clearance in Group T (TELEMEDICINE) and Group C ( CONVENTIONAL), taking a total sample size of 70, 35 in each group. Our secondary objectives include rate of cancellation of
surgery, the concordance of pre-anaesthetic checkup of visiting anesthesiologist(A2) with preliminary pre-anaesthetic
evaluation, and parents/guardian
satisfaction on preliminary PAC clearance.
|