| CTRI Number |
CTRI/2024/01/061367 [Registered on: 11/01/2024] Trial Registered Prospectively |
| Last Modified On: |
08/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Correlation between background health status of elderly patients and outcomes after surgery. |
|
Scientific Title of Study
|
Frailty status and postoperative outcomes of elderly patients undergoing elective noncardiac 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 |
Dr Manomi S |
| Designation |
Postgraduate Resident |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesiology
Amrita Institute of Medical Sciences
Ponekkara PO
Edapally,Kochi,Ernakulam
Kerala
Ernakulam
KERALA
682041
India |
| Phone |
8075838542 |
| Fax |
04842802020 |
| Email |
manomi1992april@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyam Sundar P |
| Designation |
Additional Professor |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesiology
Amrita Institute of Medical Sciences
Ponekkara Rd ,P.O
Edapally,Kochi,Ernakulam
Kerala
Ernakulam
KERALA
682041
India |
| Phone |
9895093011 |
| Fax |
|
| Email |
pssundar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shyam Sundar P |
| Designation |
Additional Professor |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesiology
Amrita Institute of Medical Sciences
Ponekkara Rd ,P.O
Edapally,Kochi,Ernakulam
Kerala
Ernakulam
KERALA
682041
India |
| Phone |
9895093011 |
| Fax |
|
| Email |
pssundar@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Sciences, Kochi |
|
|
Primary Sponsor
|
| Name |
Dr Manomi S |
| Address |
Department of Anaesthesiology
Amrita Institute of Medical Sciences Ponekkara P O Edapally Kochi Ernakulam Kochi Kerala |
| 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 Shyam Sundar P |
Amrita Institute of Medical Sciences |
AIMS Ponekkara PO
Kochi-682041
Ernakulam
KERALA |
9895093011
04842802020
pssundar@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Commitee - Amrita School of Medicine |
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 |
| Comparator Agent |
NIL |
NIL |
| Comparator Agent |
Nil |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 65 years
Elective Surgeries
Patient undergoing major surgeries(more than 3 hours) under general anaesthesia or regional anaesthesia |
|
| ExclusionCriteria |
| Details |
Patient unable to undergo frailty assessment
Cardiac surgeries |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient mortality |
at 28th day after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative ventilation, length of postop ICU stay, Length of hospital stay |
Postoperative ventilation at the time of discharge from ICU, length of postop ICU stay at the time of discharge from ICU, Length of hospital stay at the time of discharge from hospital |
|
|
Target Sample Size
|
Total Sample Size="117"
Sample Size from India="117"
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)
|
18/01/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
It is a prospective cohort study to be conducted in older individuals more than 65 years undergoing noncardiac surgeries using the modified frailty index score .The data to be collected as a part of the study includes post operative mortality, postop ventilation, length of ICU stay, length of hospital stay. The patient shall be telephonically followed up after 28 days for assessment of their overall health status. |