| CTRI Number |
CTRI/2019/05/019253 [Registered on: 21/05/2019] Trial Registered Prospectively |
| Last Modified On: |
19/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
a case control study to assess the risk factors which are responsible in the development of delirium |
|
Scientific Title of Study
|
“A case control study to assess the factors affecting the development of delirium in patients admitted in main ICU of Nehru hospital, PGIMER, Chandigarh, 2018-20.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
kamlesh thakur |
| Designation |
M.Sc. Nursing student |
| Affiliation |
NINE PGIMER CHANDIGARGH |
| Address |
vpo langna teh. joginder nagar distt mandi hp
vpo langna teh. joginder nagar distt mandi hp
Mandi
HIMACHAL PRADESH
176120
India |
| Phone |
8219868196 |
| Fax |
|
| Email |
kamleshthakur870@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Neena Vir Singh |
| Designation |
lecturer |
| Affiliation |
NINE PGIMER CHANDIGARGH |
| Address |
NINE PGIMER CHANDIGARGH
pin code- 160011
NINE PGIMER CHANDIGARGH
pin code- 160011
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8146552482 |
| Fax |
|
| Email |
neenasingh_2@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
kamlesh thakur |
| Designation |
M.Sc. Nursing student |
| Affiliation |
NINE PGIMER CHANDIGARGH |
| Address |
vpo langna teh. joginder nagar distt mandi hp
NINE PGIMER CHANDIGARGH
pin code-160011
Mandi
HIMACHAL PRADESH
176120
India |
| Phone |
8219868196 |
| Fax |
|
| Email |
kamleshthakur870@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Research |
|
|
Primary Sponsor
|
| Name |
National Institute of Nursing Education |
| Address |
sector 12 NINE PGIMER Chandigarh |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| Post Graduate Institute of medical Research |
sector 12 chandigargh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Kamlesh Thakur |
Nehru hospital PGIMER chandigarh |
Main ICU Nehru Hospital, first floor
Chandigarh
CHANDIGARH |
08219868196
kamleshthakur870@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sub committee of the Institute Ethic Committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G939||Disorder of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria -
•The patients whose legal guardians are ready to give consent for participation.
•Patients diagnosed with delirium as per CAM - ICU
•Patients of age > 18 years.
Inclusion criteria for Control –
•The patients whose legal guardians are ready to give consent for participation.
•Patients without delirium as per CAM – ICU.
•Patients of same age group and gender as of case.
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria -
•Any previous neurological deficit that compromises cognition of patient.
•Patient on psychoactive drugs prior to admission in ICU.
•Patients with history of allergy to sedatives.
•Comatose patients (G.C.S. < 8).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identification risk factor of delirium |
3 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Identification risk factor of delirium |
1 year |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/07/2019 |
| 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
|
It will be published in a good journal after the completion of study.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The delirium is found in most of the patient admitted in ICU, in this study I will assessing the risk factors which are responsible for the development of delirium. in the present case- control study I will be assessing the risk factors which makes a person prone to develop delirium. The cases will be identified first and then cases of same gender and age group will be selected, both the cases and control will be studied retrospectively to find out the risk factors. |