| CTRI Number |
CTRI/2025/02/081210 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
25/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
The incidence and risk factors of post operative confusion in head neck cancer surgical patients |
|
Scientific Title of Study
|
Incidence of delirium and postoperative outcomes in head neck cancer surgical patients- 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 |
Dr Malini Joshi |
| Designation |
Professor, Department of Anaesthesia, Critical Care and Pain, ACTREC, Tata Memorial Centre |
| Affiliation |
Tata Memorial Centre |
| Address |
ACTREC, Tata Memorial Centre, Sector 22, Kharghar, Navi Mumbai
Address
Mumbai
MAHARASHTRA
410210
India
Mumbai
MAHARASHTRA
410210
India |
| Phone |
9987226657 |
| Fax |
|
| Email |
jmalini2007@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Malini Joshi |
| Designation |
Professor, Department of Anaesthesia, Critical Care and Pain, ACTREC, Tata Memorial Centre |
| Affiliation |
Tata Memorial Centre |
| Address |
ACTREC, Tata Memorial Centre, Sector 22, Kharghar, Navi Mumbai
Address
Mumbai
MAHARASHTRA
410210
India
MAHARASHTRA
410210
India |
| Phone |
9987226657 |
| Fax |
|
| Email |
jmalini2007@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Athira Celine Justine |
| Designation |
Junior Resident, Department of Anaesthesia, Critical Care and Pain, Tata Memorial Centre |
| Affiliation |
Tata Memorial Centre |
| Address |
Dept of Anaesthesiology, Critical Care and Pain, 7th floor, Rajarao Shodhika Building, ACTREC, Tata Memorial Centre, Sector 22, Kharghar,
Navi Mumbai
Address
Mumbai
MAHARASHTRA
410210
India
Mumbai
MAHARASHTRA
410210
India |
| Phone |
7639412964 |
| Fax |
|
| Email |
athira.justine98@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ACTREC Tata Memorial Centre |
| Address |
ACTREC Tata Memorial Centre, Sector 22, Kharghar Navi Mumbai |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shilpushp Bhosale |
Tata Memorial Centre |
Dept of Anaesthesiology, Critical Care and Pain, 7th floor, Rajarao Shodhika Building, ACTREC, Tata Memorial Centre, Sector 22, Kharghar, Navi Mumbai
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
9619310657
shilbhosale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACTREC, Institutional Ethical Committee 3 |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All adult postoperative head neck patients admitted to recovery room or ICU for more than 24 hrs |
|
| ExclusionCriteria |
| Details |
Patients with prior psychiatric illness or patients on medications that will influence delirium |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Study the incidence of Delirium in postoperative adult head and neck surgical patients
2. To evaluate the impact of delirium on various post-operative outcome, including: Length of hospital stay, rate of complication (e.g. Infection, respiratory issues), need for additional interventional (e.g. Reoperation)
3. Risk factor identification: identify risk factors for developing delirium, such as age, comorbidity, medication use, and surgical complexity. |
Data will be collected over a period of 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. 30-day Clavien Dindo complication rate
2. ICU & Hospital length of stay & outcomes
|
Data will be collected over a period of 1 year |
|
|
Target Sample Size
|
Total Sample Size="1200"
Sample Size from India="1200"
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)
|
03/03/2025 |
| 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 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
|
Patients undergoing major head and neck onco-surgeries can have significant postoperative morbidity. Delirium, a neuropsychiatric syndrome, is definedas a disturbance in attention, awareness, and cognition that develops over a short period oftime and fluctuates in severity. It is transient and usually reversible. Delirium in critically care population is reported between 20 to 40%. It can be either hyperactive, hypoactive or mixed type. It is important to assess delirium as it can have negative impact on the outcome and recovery from critical illness. We are using the CAM-ICU score to detect delirium in out population. We will study the incidence of delirium, the impact in post op outcome and risk factors associated with it. The data will be collected over a period of 1 year in ACTREC, Tata Memorial Centre. The data will be collected from the case record form and there will be no direct patient contact. Data will be maintained securely and will not be disclosed at any point during the study. |