| CTRI Number |
CTRI/2024/08/072677 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
How can an ICU Clinic help the patients who were admitted in ICU to overcome physical and mental illness. |
|
Scientific Title of Study
|
Design and implementation of Post ICU clinic (PICUC) at AIIMS Bhubaneswar - a mixed methods 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 |
Sourav Chatterjee |
| Designation |
DM student |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Central ICU, 3rd Floor,
Hospital Building,
AIIMS, Sijua, Patrapada,
Bhubaneswar-751019
Khordha
ORISSA
751019
India |
| Phone |
8777026401 |
| Fax |
|
| Email |
sourav.agp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swagata Tripathy |
| Designation |
Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Academic Building, Room no 401, AIIMS Bhubaneswar
Sijua, Patrapada,
Bhubaneswar-751019
Khordha
ORISSA
751019
India |
| Phone |
8763400534 |
| Fax |
|
| Email |
tripathyswagata@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swagata Tripathy |
| Designation |
Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Academic Building, Room no 401, AIIMS Bhubaneswar
Sijua, Patrapada,
Bhubaneswar-751019
Khordha
ORISSA
751019
India |
| Phone |
8763400534 |
| Fax |
|
| Email |
tripathyswagata@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Bhubaneswar
Sijua, Patrapada,
Bhubaneswar,Odisha -751019 |
|
|
Primary Sponsor
|
| Name |
Sourav Chatterjee |
| Address |
AIIMS Bhubaneswar
Sijua, Patrapada,
Bhubaneswar-751019 |
| Type of Sponsor |
Other [self] |
|
|
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 Sourav Chatterjee |
All India Institute of Medical Sciences, Bhubaneswar |
PAC Clinic,Room No 151, 1st Floor, OPD building, Department of Anaesthesiology and Critical Care, AIIMS Bhubaneswar, Sijua, Patrapada, Bhubaneswar, Orissa-751019
Khordha
ORISSA |
8777026401
sourav.agp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z518||Encounter for other specified aftercare, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
• Patients diagnosed as septic shock, ARDS
• ICU stay more than 3 days
• Patients required mechanical ventilation more than 2 days
• Patients with multiorgan failure requiring organ support like RRT
|
|
| ExclusionCriteria |
| Details |
•Refusal to give consent
•Patients with neurological impairments
•H/O psychiatric illness
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| develop an evidence based post icu recovery clinic model and evaluate the feasibility and success of this model |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Incidence and nature of physical problems patients suffers after discharge from ICU
2.Incidence of anxiety, depression and PTSD
3.Incidence of cognitive dysfunctions |
12 months after discharge from ICU |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
02/09/2024 |
| 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="1"
Months="0"
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
|
| Patients discharged from ICU suffer variety of physical impairments, psychological impairments or cognitive dysfunctions or combinations of these. This symptoms are collectively called as Post Intensive Care Syndrome (PICS). Post ICU recovery clinic was established in different countries to identify the patients suffering from PICS and address the unmet healthcare needs of those patients to maintain continuity of care. Recent data from different post icu recovery clinic suggests low attendance and high attrition to clinic. Many barriers and facilitators have been identified and different approach to reach out to patients have tried. In our study I will develop a model of post intensive care clinic (PICUC) and testify the success of the model to patients in terms of attendance and attrition of patients suffering from PICS after discharge from ICU of AIIMS Bhubaneswar and at the same time will identify the incidence of different symptoms of PICS in our study population. | |