| CTRI Number |
CTRI/2023/03/050901 [Registered on: 20/03/2023] Trial Registered Prospectively |
| Last Modified On: |
18/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Incidence of altered mental state in patients admitted in ICU |
|
Scientific Title of Study
|
A prospective observational study on the incidence of delirium among the patients in intensive care unit. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
POOJA |
| Designation |
POST GRADUATE STUDENT MSC CRT |
| Affiliation |
DEPARTMENT OF ANAESTHESIOLOGY, SRM MCH AND RC, SRMIST, KATTANKULATHUR. |
| Address |
NO 6/16
VAKIL STREET
RANIPET
632401
Vellore
TAMIL NADU
632401
India |
| Phone |
|
| Fax |
|
| Email |
poojapattabiraman@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KARTHIK K |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SRMIST |
| Address |
ROOM NO 218,
DEPARTMENT OF ANAESTHESIOLOGY,
A BLOCK, SECOND FLOOR,
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER
SRMIST
SRM NAGAR
KATTANKULATHUR
CHENGALPATTU DISTRICT
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9444586662 |
| Fax |
|
| Email |
karthikk1@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
MIRUNALINI G |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SRMIST |
| Address |
ROOM NO. 219, DEPARTMENT OF ANAESTHESIOLOGY,
SECOND FLOOR A BLOCK,
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER
SRMIST
SRM NAGAR
KATTANKULATHUR
CHENGALPATTU DISTRICT
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9486131643 |
| Fax |
|
| Email |
mirunalini.gunaseelan@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER
SRMIST,
SRM NAGAR,
KATTANKULATHUR
603203
TAMIL NADU |
|
|
Primary Sponsor
|
| Name |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
| Address |
SRM MCH AND RC
SRMIST
SRM NAGAR
KATTANKULATHUR
CHENGALPATTU DISTRICT
603 203
TAMIL NADU |
| 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 |
| KARTHIK K |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
Department of anaesthesiology,
ICU complex, FIRST FLOOR,
SRM MEDICAL COLLEGE AND HOSPITAL,
SRMIST
SRM NAGAR
KATTANKULATHUR
CHENGALPATTU DISTRICT
Kancheepuram
TAMIL NADU |
9444586662
karthikk1@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R419||Unspecified symptoms and signs involving cognitive functions and awareness, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
• Patients in age group above 18 years
• Patients who had Richmond agitation and sedation scale (RASS) score between -2 and +4
|
|
| ExclusionCriteria |
| Details |
• Patients who had been treated with antipsychotic drugs within the previous 10 days
• Patients who had history of dementia
• Patients who were suffering from acute alcohol withdrawal syndrome,
• Patients who had delirium or serious auditory or visual disorders before ICU admission
• Patients who were unable to understand the Tamil or English languages
• Patients were severely mentally disabled, suffered from a terminal illness,
• Patients of age group < 18 years
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of delirium
|
Incidence of delirium from 48 hours after admission in ICU till discharge from ICU
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Risk factors associated with delirium
validation of CAM ICU score |
48 hours after admission to ICU |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
01/05/2023 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mirunalini.gunaseelan@gmail.com].
- For how long will this data be available start date provided 01-05-2023 and end date provided 30-04-2024?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The patients who qualify as per
the selection criteria will be given a clear explanation in their vernacular
language. A written consent will be obtained in each case.
The following information will be collected upon
admission: sex, date of admission, category of admission, diagnosis,
description of previous and current use of sedatives or antipsychotic drugs,
other medication used, Acute Physiological and Chronic Health Evaluation II
(APACHE II) score, presence of invasive procedures, monitoring data, and type
of organ support.
Patients eligible for the study will be
evaluated to detect delirium using the Confusion Assessment Method (CAM)‑ICU
daily.
CAM-ICU method will be done by the principal
investigator and will record the scores till the patient gets discharged.The
diagnosis of the delirium will be done by the physicians.
It is an instrument simple to use; the score
varies from 1 to 7: level (1) refers to a patient who cannot respond to voice
or physical stimulation and (7) to a combative violent patient. Every patient
will be daily evaluated until his/her RASS score is ≥4, so he/she can be
assessed for delirium using the CAM‑ICU. THE FOLLOWING PARAMETERS
WILL BE COLLECTED 1.HEART RATE 2.BLOOD PRESSURE 3.SPO2 4.RESPIRATORY RATE 5.HB 6.HCT 7.TC 8.DC 9.PLATELET 10.LFT 11.RFT 12.INR 13.BUN/CREATININE 14.UREA 15.SODIUM 16.POTASSIUM 17.1MAGNESIUM 18.CALCIUM 19.APACHE II
20.CAM-ICU SCORE |