| CTRI Number |
CTRI/2021/05/033672 [Registered on: 18/05/2021] Trial Registered Prospectively |
| Last Modified On: |
17/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Accuracy of POSSUM and P-POSSUM scores in predicting overall outcomes after orthopaedic surgeries. |
|
Scientific Title of Study
|
Accuracy of POSSUM and P-POSSUM scores in predicting morbidity and mortality, among
patients undergoing orthopaedic surgeries – a prospective longitudinal study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditi Prakash |
| Designation |
Academic JR |
| Affiliation |
AIIMS Bhopal |
| Address |
Dept. of Anesthesiology, AIIMS Bhopal
Saket Nagar, Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8210460288 |
| Fax |
|
| Email |
aditi.prakash749@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunaina Tejpal |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Bhopal |
| Address |
Dept. of Anesthesiology, third floor, AIIMS Bhopal
Saket Nagar, Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9540946869 |
| Fax |
|
| Email |
drtejpal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunaina Tejpal |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Bhopal |
| Address |
Department of Anesthesiology, third floor, AIIMS Bhopal
Saket Nagar, Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9540946869 |
| Fax |
|
| Email |
drtejpal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Bhopal |
| Address |
Saket nagar, Bhopal |
| Type of Sponsor |
Research institution |
|
|
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 Aditi Prakash |
AIIMS Bhopal |
Department of Anesthesiology, third floor.
Bhopal
MADHYA PRADESH |
8210460288
aditi.prakash749@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee- Post Graduate Research IHEC-PGR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified. Ayurveda Condition: Healthy, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing orthopaedic surgeries under anaesthesia
|
|
| ExclusionCriteria |
| Details |
1. Pregnant females
2. Patients who did not consent for the study
3. Patients where surgery did not proceed
4. Patients who could not be followed up
5. Patients with missing data |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
POSSUM and P-POSSUM predicted mortality and POSSUM
predicted morbidity in patients undergoing orthopaedic surgeries. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative morbidity as classified by Clavien Dindo classification |
At the end of patient follow up |
|
|
Target Sample Size
|
Total Sample Size="125"
Sample Size from India="125"
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)
|
27/05/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A prospective longitudinal study to be conducted to compare calculated and observed possum and p possum scores for morbidity and mortality in patients understanding orthopedic surgeries under anesthesia, at AIIMS Bhopal over a period of one year. Patients are to be followed up at a period of one month post operatively to record any morbidity or mortality. |