| CTRI Number |
CTRI/2019/06/019530 [Registered on: 04/06/2019] Trial Registered Prospectively |
| Last Modified On: |
03/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive |
| Study Design |
Other |
|
Public Title of Study
|
To assess the Delirium among adults in ICU. |
|
Scientific Title of Study
|
A study to assess the factors contributing to delirium among patients admitted to intensive care units (ICU) of selected hospital of Udupi, Karnataka |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prasannakumara |
| Designation |
Nurse practitioner in critical care |
| Affiliation |
Manipal college of nursing, manipal |
| Address |
Manipal college of nursing, MAHE, manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9060186606 |
| Fax |
|
| Email |
pk9518brahmavar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr shwethpriya R |
| Designation |
Professor |
| Affiliation |
Kasturba Hospital Manipal |
| Address |
Critical Care medicine unit head and incharge
Kasturba Hospital Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9964668404 |
| Fax |
|
| Email |
drshwethapriya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Shobha Kamath |
| Designation |
Lecturer |
| Affiliation |
Manipal college of nursing, MAHE, Manipal |
| Address |
Manipal college of nursing MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7975441556 |
| Fax |
|
| Email |
shobha.nvr@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Self Prasannakumara
Manipal college of Nursing MAHE manipal |
|
|
Primary Sponsor
|
| Name |
Prasannakumara |
| Address |
Manipal college of nursing,MAHE,manipal |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr shwethapriya R |
Kasturba Hospital manipal |
| Mrs Shobha Kamath |
Manipal college of nursing,MAHE,manipal |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prasannakumara |
Kasturba Hospital Manipal |
Critical care Medicine ICU1-ICU2 1st floor and Emergency medicine Department ground floor, Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
9060186606
pk9518brahmavar@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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G934||Other and unspecified encephalopathy, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patient who are admitted to ICU for more than 24 hours,
inattentive and ventilated patients whose guardians will permit to observe the patient for delirium using CAM-ICU tool |
|
| ExclusionCriteria |
| Details |
patients who are admitted to MICU
ICU observation patient less than 24 hours,
Elderly age above 65years,
history of psychiatric disorder patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing the delirium in ICU admitted patient |
once, that is after 24 hours of ICU stay. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to seek Medical help |
after the study period |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/06/2019 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a observational study A study to assess the factors contributing to delirium among patients admitted to Intensive care units (ICU) of selected hospital of Udupi, karnataka. patients are admitted to ICU in Kasturba Hospital manipal. The papulation are the male and female age between 18 to 65 years. Administration permission has been taken from the college and ethical clearance from institutional ethical committee. |