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CTRI Number  CTRI/2024/11/076437 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 29/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Crossover Trial 
Public Title of Study   A study to compare if anaesthesia checkup done over video call is as effective as one done in-person, in patients undergoing surgery 
Scientific Title of Study   Is virtual pre-anesthesia check-up (PAC) as effective as in-person PAC? – A cross-over study 
Trial Acronym  NIl 
Secondary IDs if Any  
Secondary ID  Identifier 
4468_Version 1.0 dated 15.04.2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priya Ranganathan 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Room 210, 2nd Floor, Main Building, Department of Anaesthesia, Tata Memorial Hospital, Ernest Borges Road, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  24177000  
Fax    
Email  drpriyaranganathan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Priya Ranganathan 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Room 210, 2nd Floor, Main Building, Department of Anaesthesia, Tata Memorial Hospital, Ernest Borges Road, Parel


MAHARASHTRA
400012
India 
Phone  24177000  
Fax    
Email  drpriyaranganathan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pranav Tandon 
Designation  Post Graduate Student 
Affiliation  Tata Memorial Hospital 
Address  Room 210, 2nd Floor, Main Building, Department of Anaesthesia, Tata Memorial Hospital, Ernest Borges Road, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  7991304374  
Fax    
Email  prat327@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Ernest Borges Road, Parel, Mumbai 400012 
Type of Sponsor  Research institution and hospital 
 
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 Priya Ranganathan  Tata Memorial Centre  Room 210, Department of Anaesthesia, 2nd Floor, Main Building, Ernest Borges Road, Parel, Mumbai 400012
Mumbai
MAHARASHTRA 		 24177000

drpriyaranganathan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Hospital Institutional Ethics Committee l  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, (2) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  In-person PAC  It will be carried out by a resident or consultant anesthesiologist in the PAC room. The PAC is done in a standard structured manner and consists of history taking, physical examination and review or reports and investigations. The PAC report will be entered on a written PAC form, which will remain with the investigator until the participant has completed the virtual PAC. This will ensure that the person conducting the virtual PAC has no access to the report of the in-person PAC. 
Intervention  Virtual PAC  It will be carried out by another anesthesiologist with the same level of training. Patients will be seated in a separate room, with a relative and the consultation will be done via WhatsApp, using a smartphone. The anesthesiologist performing the PAC will be seated at another part of the hospital and will be able to access the EMR to review patient history and investigations. They will also have access to basic parameters such as the height, weight, heart rate, blood pressure and saturation using pulse oximetry, which will be noted by the nurse in the out-patient department. If the patient has tests or specialist consults performed outside TMH, these reports will be scanned and shared with the anesthesiologist separately. The anesthesiologist will record his/her findings on another copy of the PAC form. An independent observer will be present with the anesthesiologist performing the virtual PAC to ensure that the report of the in-person PAC is not referred to. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Adult patients more than or equal to 18 yrs
2. ASA grades 1 to 3
3. Planned for elective surgery and scheduled to undergo PAC
 
 
ExclusionCriteria 
Details  1. Patients with restricted mobility (Wheel-chair or trolley bound) – where accessing tele-consult facilities may be a problem
2. Patients with cognitive or hearing impairment
3. Patients who cannot speak or understand English, Hindi or Marathi
4. Refusal of consent
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome will be the degree of concordance between virtual and in-person PAC for the objectives mentioned.
In particular, a sub-group analysis will be done for those patients with
a) Difficult airway on in-person PAC
b) Cardiac and pulmonary disorders detected on in-person PAC (active wheeze, crepitations, cardiac murmur)
c) Other conditions detected at in-person PAC (e.g., undiagnosed hypertension)
 		 At the end of 24 hours of both PAC evaluation 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcomes include assessment of patient and anaesthesiologist satisfaction with the virtual PAC process  At the end of 24 hours of both PAC evaluation 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   11/11/2024 
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="0"
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  

Pre-anaesthesia check-up (PAC) is carried out before surgery to see if patients are fit to undergo surgery or have some medical conditions which need to be optimised. PAC is usually done in person by the anaesthesiologists at the PAC clinic.

The aim of this study is to examine the effectiveness of a virtual PAC as compared to an in-person PAC in patients planned for surgery at a tertiary-referral cancer centre. We will include 20 patients, who are scheduled to undergo a new PAC and 20 patients scheduled for PAC review. All participants will undergo an in-person as well as a virtual PAC. After both PACs are completed, patients will be administered a survey related to their experience. The two PACs will then be compared to assess how similar the assessment of both the anaesthesiologists was and to assess if any information was missed on either of them.

If virtual PAC is found to be effective, then it offers several benefits: decreased waiting times, decreased crowds in the PAC room, decreased need for patients to travel to the hospital, etc.  

 
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