| CTRI Number |
CTRI/2024/12/077936 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of post surgery confusion state in orthopaedic patients |
|
Scientific Title of Study
|
Incidence, risk factors and symptom profile of delirium in orthopaedic post operative patients, a prospective cohort 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 |
Miti Shah |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Psychiatry,
Kasturba Medical College,
Manipal
Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9870819602 |
| Fax |
|
| Email |
miti.shah99.ms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suma Udupa |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Psychiatry,
Kasturba Medical College,
Manipal
Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9901790003 |
| Fax |
|
| Email |
udupa.drsuma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Suma Udupa |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Psychiatry,
Kasturba Medical College,
Manipal
Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9901790003 |
| Fax |
|
| Email |
udupa.drsuma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Psychiatry (OPD No 33) and Department of Orthopaedics (OPD No 4), Kasturba Medical College, Manipal, Udupi district, Karnataka, India 576104 |
|
|
Primary Sponsor
|
| Name |
Department of Psychiatry |
| Address |
OPD No 33, Department of Psychiatry, Kasturba Medical College, Manipal, Udupi district, Karnataka 576104 |
| Type of Sponsor |
Private 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 Miti Shah |
Kasturba Hospital |
OPD No 33, Department of Psychiatry; OPD No 4, Department of Orthopaedics; Post operative ICU and wards
Udupi
KARNATAKA |
9870819602
miti.shah99.ms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: V00-Y99||External causes of morbidity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Any patient undergoing a major orthopaedic surgery.
Patient able to understand English, Hindi or Kannada.
Consent is obtained from patient or their nominated representative. |
|
| ExclusionCriteria |
| Details |
Preoperative GCS less than 15 based on records |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Inccidence of Delirium |
Post operative Day 1, Day 3, Day 5 and Day 7 or at time of discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Risk factors and symptom profile of delirium |
Post operative Day 1, Day 3, Day 5 and Day 7 or at time of discharge |
|
|
Target Sample Size
|
Total Sample Size="576"
Sample Size from India="576"
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)
|
01/01/2025 |
| 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 - NO
|
|
Brief Summary
|
All patients fitting the inclusion criteria, with their consent or their nominated representatives consent will be involved in the study. The CAM Algorithm will be administered on all the subjects by the Principal Investigator at 4 time points (unless they get discharged) which are post operative day 1, 3, 5 and 7 or on day of discharge (whichever is earlier). It will be initiated in the post operative ICU and the patient will be followed up in the ward thereafter. CAM ICU will be used for patients who aren’t able to respond verbally (eg: intubated) while CAM will be used on the rest. Relevant sociodemographic details will be collected and AD8 Dementia Screening Interview will be administered in individuals above 60 years. Additionally, Delirium Rating Scale-R-98 (DRS-R-98) will be administered on patients developing delirium. Data analysis will be done. |