| CTRI Number |
CTRI/2025/08/092996 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
The study about comparing SHAPE scoring system in predicting need of ICU care after surgery in participants of this intervention |
|
Scientific Title of Study
|
A Comparative Study of SHAPE scoring system over ASA grading system in predicting post operative ICU care in ASA three patients undergoing major surgeries |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Viswanathan E |
| Designation |
Post graduate |
| Affiliation |
ESIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
First floor, B block, Department of Anaesthesiology, ESIC Medical College and Hospital, Ashok Pillar main road, KK nagar, Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
9894973488 |
| Fax |
|
| Email |
viswadr2411@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sundaram L N |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ESIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
First floor, B block, Department of Anaesthesiology, ESIC Medical College and Hospital, Ashok Pillar main road, KK nagar, Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
9600614533 |
| Fax |
|
| Email |
sun_gallant@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sundaram L N |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ESIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
First floor, B block, Department of Anaesthesiology, ESIC Medical College and Hospital, Ashok Pillar main road, KK nagar, Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
9600614533 |
| Fax |
|
| Email |
sun_gallant@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ESIC MEDICAL COLLEGE |
| Address |
First floor, B block, Department of Anaesthesiology, ESIC Medical College and Hospital, Ashok Pillar main road, KK nagar, Chennai 600078
Tamilnadu , India |
| 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 |
| Dr Viswanathan E |
ESIC MEDICAL COLLEGE AND HOSPITAL |
First floor, B block, Department of Anaesthesiology, ESIC Medical College and Hospital, Ashok Pillar main road, KK nagar, Chennai
Chennai
TAMIL NADU |
9894973488
viswadr2411@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, ESIC MEDICAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C169||Malignant neoplasm of stomach, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
15 to 60 years
Either gender |
|
| ExclusionCriteria |
| Details |
Patient refusal
Age less than 15 years
Gross coagulopathy
Known allergy or adverse effects to anaesthesia drugs |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Through this study we can determine that SHAPE scoring system is effective in predicting post operative ICU care in ASA 3 patients |
1 hour, 6 hours, 1 day , 3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Through this study we can evaluate SHAPE scoring system in predicting unanticipated post operative ICU care in ASA 2 patients |
1 day, 3 days , 5 days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
29/08/2025 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 30-08-2027 and end date provided 30-08-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
ASA PS classification was proposed by American Society of Anaesthesiologists (ASA) in 1941, it is the commonly used system throughout the field of anaesthesia to predict the incidence of intra- and postoperative complications in surgical patients, (ASA PS) system is a (6-grade) system from ASA I to ASA VI in evaluating the patients in pre opeerative assessement.
However ASA PS system, which was routinely followed in today’s clinical practice has some limitations over the period of time, namely: Inability to distinguish disorders of different systems; inability to delineate or cumulate risk based upon multiple system involvement; to consider surgical invasiveness, or identify specific anaesthetic risk.
Dr. Mohamed Daabiss suggested the use of Tomoaki and Yoshihisa’s ASA PS 7 grade classification which takes into consideration operative and anaesthetic factors to a certain extent.However, this also seems to be quite subjective, and fails to identify single or multiple systems involvement, extent of surgical invasiveness or specificity of anaesthetic factor.
To overcome the limitations of ASA PS system,a new risk stratification scoring system,Silverman-Holt aggregate preoperative evaluation (SHAPE) was introduced by SILVERMAN & HOLT in the year 2010 which overcomes all above mentioned limitations.
In this study we include 90 participants after informed and written consent , who are undergoing major surgeries in ESIC MEDICAL COLLEGE, KK NAGAR, CHENNAI. We will use both ASA PS scoring system and SHAPE scoring system for evaluating the effectiveness of SHAPE scoring system over ASA grading system in predicting post operative ICU care in ASA 3 pateints undergoing major surgeries.
Through this study we can evaluate the effectiveness of SHAPE scoring system over ASA PS scoring system to overcome the limitations of it, as it takes only the preoperative physical status of patient into consideration which is one of the many factors affecting perioperative outcome and confusion arises in grading the patient when multiple systems are involved as not every system is involved to the same extent , so that we can predict the need of post operative ICU care in ASA 3 patients undergoing major surgeries , also to predict unanticipated post operative ICU care in ASA 2 patients in ESIC MEDICAL COLLEGE, KK NAGAR, CHENNAI, so that it will be a great help to reserve ICU beds for patients who are really in need for it, as we have limited amount of ICU beds.
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