| CTRI Number |
CTRI/2024/07/069799 [Registered on: 02/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating the attempt to modification american society of anesthesiologist classification. |
|
Scientific Title of Study
|
Evaluating the attempt to modification of American society of anaesthesiologist classification in terms of distribution of perioperative critical events compared to present American society of anaesthesiologist classification. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Roshini Thangaraj |
| Designation |
Post graduate |
| Affiliation |
Sri Ramachandra institute of higher education |
| Address |
Room Number:402,Post graduate, Department of Anaesthesiology and pain medicine , Sri Ramachandra institute of higher education, Porur, Chennai,
Chennai
TAMIL NADU
600116
India |
| Phone |
9080067913 |
| Fax |
|
| Email |
drroshinithangaraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Venkatesan |
| Designation |
PROFESSOR |
| Affiliation |
sri ramachandra institute of higher education |
| Address |
Professor, Department of Anesthesiology and pain medicine, Sri Ramachandra institute of higher education, Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9944731220 |
| Fax |
|
| Email |
venkymail2014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Venkatesan |
| Designation |
PROFESSOR |
| Affiliation |
sri ramachandra institute of higher education |
| Address |
Professor, Department of Anesthesiology and pain medicine, Sri Ramachandra institute of higher education, Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9944731220 |
| Fax |
|
| Email |
venkymail2014@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and pain medicine, Sri Ramachandra institute of higher education, Porur , Chennai, TAMIL NADU, INDIA ,600116 |
|
|
Primary Sponsor
|
| Name |
Dr Roshini Thangaraj |
| Address |
Department of Anesthesiology and pain medicine, Sri Ramachandra institute of higher education, Porur, Chennai, Tamil Nadu, India, 600116 |
| 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 Roshini Thangaraj |
Sri Ramachandra Institute Of Higher Education |
Department of Anesthesiology and pain medicine, Sri Ramachandra institute of higher education, Porur, Chennai , Tamil Nadu - 600116
Chennai
TAMIL NADU |
9080067913
drroshinithangaraj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL RESEARCH ETHICS COMMITTE |
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 |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Nil |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Modification of American society of Anesthesiologist class II into A and B and compare the critical events. |
One Week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Noticing the incidence of critical events in various categories. |
Four Weeks |
|
|
Target Sample Size
|
Total Sample Size="1372"
Sample Size from India="1372"
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)
|
15/07/2024 |
| 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="2"
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
|
The purpose of the study is to modify the current AMERICAN SOCIETY OF ANESTHESIOLOGIST CLASSIFICATION (ASA II) into a and b based on the critical events, surgical and anesthesia related complications , hence it will help in reducing the critical events , surgical and anesthesia related complications. |