| CTRI Number |
CTRI/2025/01/079599 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
The total number of new cases and causes for development of post operative patients which are admitted to surgical and trauma ICU after operation |
|
Scientific Title of Study
|
Incidence and risk factors of postoperative delirium in patients admitted to surgical and trauma ICU- A prospective observational study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vegendla Reena Joicy |
| Designation |
Post Graduate Resident Doctor |
| Affiliation |
P.D.U Government Medical College, Rajkot |
| Address |
Dept. Of Anaesthesiology
P.D.U Govt. Medical College & Hospital, Rajkot
Rajkot
GUJARAT
360001
India |
| Phone |
9492001898 |
| Fax |
|
| Email |
Reenajoicy3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vrinda P Oza |
| Designation |
Assistant Professor |
| Affiliation |
P.D.U Government Medical College, Rajkot |
| Address |
Department of Anaesthesiology, PDU Government Medical College and Hospital, Rajkot,
Rajkot
GUJARAT
360001
India |
| Phone |
9228099479 |
| Fax |
|
| Email |
vrinda.agravat@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vrinda P Oza |
| Designation |
Assistant Professor |
| Affiliation |
P.D.U Government Medical College, Rajkot |
| Address |
Department of Anaesthesiology, PDU Government Medical College and Hospital, Rajkot,
Rajkot
GUJARAT
360001
India |
| Phone |
9228099479 |
| Fax |
|
| Email |
vrinda.agravat@yahoo.com |
|
|
Source of Monetary or Material Support
|
| P.D.U Government Medical College, Rajkot -360001, Gujarat,
India |
|
|
Primary Sponsor
|
| Name |
Vegendla Reena Joicy |
| Address |
Department of Anaesthesiology, P.D.U. Government Medical College and Hospital, Rajkot-360001, Gujarat, India |
| 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 |
| Vegendla Reena Joicy |
P.D.U Government Medical College And Hospital, Rajkot - 360001, Gujarat, India |
PMSSY building 5th floor - Surgical and Neuro Icu
Trauma Building 3rd Floor - Trauma ICU
Rajkot
GUJARAT |
9492001898
Reenajoicy3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| P.D.U. Medical College, Rajkot. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F59||Unspecified behavioral syndromes associated with physiological disturbances and physical factors, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Within 7 days of Surgery
Surgery - general, neuro, hepatobiliary, plastic, otolaryngology,trauma, urosurgery
History of substance abuse or dependence
History of alcohol and smoking |
|
| ExclusionCriteria |
| Details |
Significant baseline neurological diseases, confounding in evaluation of delirium, language problem, Communication problems, pre-existing cognitive impairement, psychiatric illness, moribund patients not expected to survive
greater than 24 hrs and icu stay less than 24 hrs |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify Risk factors so that delirium can be prevented |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the incidence of post operative delirium |
1 year |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
02/02/2025 |
| 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="1"
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
|
Delirium is a common syndrome that affects 30% of hospitalised adults. Most studied have explored delirium in hospital setting and almost always in older individuals,rather than in general population. Since the incidence is more in post op icu patients there is need to identify the risk factors so that they can be minimised and delirium can be prevented |