| CTRI Number |
CTRI/2024/03/064369 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
27/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of extent of hectic work in ICU using simple new measurement tool |
|
Scientific Title of Study
|
Assessment of ICU activity/strain in relation to ICU performance using novel STRAIN tool (Simple Tool for Rational Assessment of Activity in Intensive care units - INDIA) A multicentric prospective observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NOT APPLICABLE |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sunil R |
| Designation |
Associate professor |
| Affiliation |
Manipal Academy of higher education (MAHE) |
| Address |
Multidisciplinary ICU, Department of critical care medicine, Room No 1 and 2, ICU complex 1st floor Casualty and trauma block Kasturba medical college Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8095800142 |
| Fax |
|
| Email |
sunil.r@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Sunil R |
| Designation |
Associate professor |
| Affiliation |
Manipal Academy of higher education (MAHE) |
| Address |
Multidisciplinary ICU, Department of critical care medicine, Room No 1 and 2, ICU complex 1st floor Casualty and trauma block Kasturba medical college Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8095800142 |
| Fax |
|
| Email |
sunil.r@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sunil R |
| Designation |
Associate professor |
| Affiliation |
Manipal Academy of higher education (MAHE) |
| Address |
Multidisciplinary ICU, Department of critical care medicine, Room No 1 and 2, ICU complex 1st floor Casualty and trauma block Kasturba medical college Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8095800142 |
| Fax |
|
| Email |
sunil.r@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba medical college Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Sunil R |
| Address |
Department of critical care medicine ICU complex First floor Casualty and trauma block Kasturba medical college Madhav Nagar Manipal |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Meghana Madi |
Department of internal medicine Kasturba medical college Mangaluru |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Meghana Madi |
Multidisciplinary ICU |
5th floor Kasturba medical college Attavar Mangaluru
Dakshina Kannada
KARNATAKA |
9611416963
meghana.madi@manipal.edu |
| Dr Sunil R |
Multidisciplinary ICU |
ICU complex First floor Casualty and trauma block Kasturba medical college Manipal
Udupi
KARNATAKA |
8095800142
sunil.r@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional ethical clearance committee Kasturba medical college Mangaluru |
Submittted/Under Review |
| Kasturba medical college and Kasturba Hospital Institional ethics committee Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Study on level of activity in ICU in terms of magnitude of organ supports offered and its relation to ICU performance |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Study looks at ICU parameters regarding how workload is affecting ICU performance. No direct patient parameters involved. |
|
| ExclusionCriteria |
| Details |
Study looks at ICU parameters regarding how workload is affecting ICU performance. No direct patient parameters involved. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the association between magnitude of ICU strain as assessed by ‘STRAIN’ tool and standardized mortality ratio. |
Two months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the association between magnitude of ICU strain/ activity via ‘STRAIN’ tool & other key quality indicators for intensive care unit performance. |
Two months |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
01/04/2024 |
| 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="2"
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
|
There are multiple quality indicators looking at performance of ICU such as readmission rate, reintubation rate, standardized mortality ratio. STRAIN is a novel tool which looks at ICU performance in co relation to magnitude of life supports offered in ICU. This can be used in further course as a tool in managing ICU logistics, both human resource and non human aspects of ICU care such as dialysis, ventilator, infusions etc.. |