| CTRI Number |
CTRI/2022/02/040522 [Registered on: 22/02/2022] Trial Registered Prospectively |
| Last Modified On: |
03/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To assess the practices of investigation and referral before elective surgery |
|
Scientific Title of Study
|
Impact of prevalent practice of preoperative investigation and interdepartmental referral of patients posted for elective non-cardiac surgery in a tertiary-care teaching hospital: A prospective hospital-based cohort study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
POOJA SINGH |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
AIIMS BHOPAL |
| Address |
DEPARTMENT OF ANESTHESIOLOGY AND CRITICAL CARE AIIMS BHOPAL
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
09318339394 |
| Fax |
|
| Email |
pooja.anesth@aiimsbhopal.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
ANSHIU PRIYANKA LAKRA |
| Designation |
SENIOR RESIDENT |
| Affiliation |
AIIMS BHOPAL |
| Address |
department of anesthesiology
3 rd floor
AIIMS
saket nagar
bhopal
Aiims bhopal, saket nagar bhopal
Bhopal
MADHYA PRADESH
462022
India |
| Phone |
9826642446 |
| Fax |
|
| Email |
anshu.priyanka14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
anshu priyanka lakra |
| Designation |
senior resident |
| Affiliation |
AIIMS BHOPAL |
| Address |
department of anesthesiology
3 RD FLOOR
AIIMS SAKET NAGAR BHOPAL
AIIMS bhopal
Saket nagar
Bhopal
Bhopal
MADHYA PRADESH
462022
India |
| Phone |
09826642446 |
| Fax |
|
| Email |
anshu.priyanka14@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCE BHOPAL, SAKET NAGAR, BHOPAL |
|
|
Primary Sponsor
|
| Name |
DR POOJA SINGH |
| Address |
DEPARTMENT OF ANESTHESIOLOGY,
AIIMS BHOPAL, SAKET NAGAR
462020 |
| Type of Sponsor |
Other [SELF] |
|
|
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 POOJA SINGH |
AIIMS BHOPAL |
3 Rd floor,DEPARTMENT OF ANESTHESIOLOGY
Bhopal
MADHYA PRADESH |
9340969292
pooja.anesth@aiimsbhopal.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional human ethics commitee AIIMS BHOPAL |
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 |
| Intervention |
NIL |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ALL PATIENT POSTED FOR ELECTIVE NON CARDIAC SURGERY
ASA GRADE 1,2,3,4, |
|
| ExclusionCriteria |
| Details |
PATIENT POSTED FOR CARDIAC AND NEUROSURGERY
PATIENT POSTED FOR EMERGENCY SURGERY
PREGNANT WOMEN |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To estimate the percentage of unindicated preoperative tests (according to NICE guidelines) conducted for preoperative PAC fitness.
2.To estimate the percentage of inter-departmental referrals with positive findings.
3.To do a cost analysis of unindicated tests and its financial implication on patients/Institution.
|
6 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To estimate the percentage of patients with abnormal findings on investigations leading to delay in acquiring PAC fitness.
2. To estimate the percentage of referrals with positive finding requiring further intervention for optimization of patients.
3. To estimate the average number of PAC visits to get PAC fitness.
4. To estimate the cancellation rate of the surgery due to inadequate optimization on the day of surgery
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="400" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/02/2022 |
| Date of Study Completion (India) |
03/11/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
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)?
Response - NO
|
|
Brief Summary
|
This is the prospective obserevational hospital-based cohort study. our aim is to estimate preoperative unindicated test out of total number of pre operative investigation conducted for pac fitness , to estimate the percentage of interdepartmental transfer with positive finding, to do a cost analysis of unindicated test. The practice of routine preoperative investigation and referrals is widely prevalent in india, with raising cost the healthcare industry need to minimize additional expenses incurred through this investigation, therefore this study will be conducted to assess the preoperative investigation and referrals practice in tertiary care teaching hospital in central india. various outcome parameters are 1.preoperative investigation done by the surgeon and anesthesiologist and its comparision with standard guidelines. 2. total no of patient referred to various speciality and their positive findings. 3. cost analysis of indicated and unindicated test. 4.average no of pac to get fitness 5. cancellation of surgery due to inadequate optimization on the day of surgery. |