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
|
|
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
|
|
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
|
|
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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