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CTRI Number  CTRI/2019/05/019015 [Registered on: 09/05/2019] Trial Registered Prospectively
Last Modified On: 21/12/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   A observational study to evaluate the impact of pre-operative investigations on resource utilisation and peri-operative management in elective surgeries. 
Scientific Title of Study   A prospective observational study to evaluate the impact of pre-operative investigations on resource utilisation and peri-operative management in elective surgeries. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Hemant Vanjare 
Designation  DNB Resident 
Affiliation  Hindu Rao Hospital and NDMC Medical College 
Address  Department of Anaesthesiology Ground Floor, Opposite ICU
Department of Anaesthesiology Ground Floor, Opposite ICU
North
DELHI
110007
India 
Phone  08109788337  
Fax    
Email  drhemantvanjare@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rashmi Duggal 
Designation  Head of Department 
Affiliation  Hindu Rao Hospital and NDMC Medical College 
Address  Department of Anaesthesiology Hindu Roa Hospital
Department of Anaesthesiology Hindu Roa Hospital
North
DELHI
110007
India 
Phone  08109788337  
Fax    
Email  rashmi.duggal.10@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Hemant Vanjare 
Designation  DNB Resident 
Affiliation  Hindu Rao Hospital and NDMC Medical College 
Address  Hindu Rao Hospital Department of Anaesthesiology
Department of Anaesthesiology
North
DELHI
110007
India 
Phone  08109788337  
Fax    
Email  drhemantvanjare@gmail.com  
 
Source of Monetary or Material Support  
Hindu Rao Hospital Department of Anaesthesiology Malkaganj, Delhi 
 
Primary Sponsor  
Name  Hindu Rao Hospital and NDMC Medical College 
Address  Sabzi Mandi, Malkaganj, Delhi 7 
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 
HEMANT VANJARE  Hindu Rao Hospital & NDMC Medical College  Department of Anaesthesiology Ground floor, Opposite ICU
North
DELHI 
08109788337

drhemantvanjare@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
HINDU RAO HOSPITAL  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: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients designated ASA grade I or grade II
2. Patients belonging to 16-60 years age group. 
 
ExclusionCriteria 
Details  Patients refusing to participate in study
Pregnant patients,
Bedridden or Immobile patients 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
High prevalance of routine pre-operative investigations and low impact of abnormal test result on peri-operative anaesthesia management.  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Pre-operative investigations and referral practices are not comparable with the standard guidelines and therefore additional resources are utilised.  6 months 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
Final Enrollment numbers achieved (Total)= "500"
Final Enrollment numbers achieved (India)="500" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/05/2019 
Date of Study Completion (India) 15/10/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 15/10/2019 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  
PRIMARY OBJECTIVE
- To compare pre-operative investigations and referral practices with the standard guidelines and to evaluate additional resources utilised as a result of it.
- To find the prevalence and impact of abnormal test result on peri-operative anaesthesia management.
SECONDARY OBJECTIVE
-To find patient satisfaction related to pre-operative evaluation.
-Any other observation arising during the study.

Patients attending Pre-Anaesthesia Clinic for pre‑anaesthesia evaluation and risk stratification before planned elective surgeries fulfilling inclusion criteria will be included in the study. Their demographic parameters, date of arrival in PAC, ASA status, Grade of surgery according to NICE guidelines will be recorded. Number of investigation already performed before arriving in PAC and their results in terms of normal and abnormal tests will be noted. Tests will be considered as abnormal if they are not within normal limits as assigned by institutional laboratory. Based on the guidelines, the tests will considered as required or not required. Number of newly diagnosed comorbidity (disease) from the investigations will also be noted. Numbers of abnormal tests and their impact will be expressed in absolute number as well as percentage scale
These patients will then be traced on the day before surgery when they undergo pre-operative evaluation again, here patients satisfaction towards pre-operative clinic will be accessed. Then on the day of surgery, patient’s plan of anaesthetic management will be noted.
An abnormal test result will be said to be impactful if it resulted in referral, delay, further investigations, retesting as well as changes in plan of anaesthetic management. Impact will be considered to be significant only if it led to a change in the perioperative anaesthetic management (i.e., postponing the elective case for further optimisation, changes in the on‑going management, altering the anaesthetic procedure and monitoring plan.)
Cost analysis will be done for every test that will be considered not necessary based on NICE guidelines. The financial implications on the patient and the institute will be analysed.
The investigations done for diagnostic purposes will be excluded from this study. Any disease specific investigation which could be expected from patients history or clinical examination will not be considered impact as these will not be routine investigation.
The data will be collected by a fixed designated anaesthesiologist for the entire duration of the study. However, designated anaesthesiologist will not filter out any investigations. The designated anaesthesiologist (data collector) also will not intervene to modify the PAC process conducted by other colleague of the same rank. No surgeons or the anaesthesiologists will be informed about the study to remove bias. The patients who will be directly evaluated by the designated anaesthesiologist will not included in the study

 
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