| CTRI Number |
CTRI/2024/05/068183 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of free health care scheme on ICU bed utilization. A prospective observational study in a tertiary care medical college hospital |
|
Scientific Title of Study
|
Impact of free health care scheme on ICU bed utilization. A prospective observational study in a tertiary health care Centre. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tapan Biswas |
| Designation |
DM Resident |
| Affiliation |
IMS and SUM Hospital, Bhubaneswar, Kalinga Nagar |
| Address |
IMS and SUM Hospital, Bhubaneswar, Kalinga Nagar
Khordha
ORISSA
751013
India |
| Phone |
9830747182 |
| Fax |
|
| Email |
tapan.biswas75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof.(dr.) Sanghamitra Mishra |
| Designation |
Dean |
| Affiliation |
IMS and SUM Hospital, Bhubaneswar, Kalinga Nagar |
| Address |
IMS and SUM Hospital, Bhubaneswar, Kalinga Nagar
Khordha
ORISSA
751013
India |
| Phone |
8847867034 |
| Fax |
|
| Email |
dean.ims@soa.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Tapan Biswas |
| Designation |
DM Resident |
| Affiliation |
IMS and SUM Hospital, Bhubaneswar, Kalinga Nagar |
| Address |
IMS and SUM Hospital, Bhubaneswar, Kalinga Nagar
Khordha
ORISSA
751013
India |
| Phone |
9830747182 |
| Fax |
|
| Email |
tapan.biswas75@gmail.com |
|
|
Source of Monetary or Material Support
|
| IMS and SUM hospital, Kalinga Nagar,Bhubaneswar, odissa, Pin 751003 |
|
|
Primary Sponsor
|
| Name |
Sanghamitra Mishra |
| Address |
IMS and SUM Hospital, Kalinga Nagar, Bhubaneswar, Orissa. Pincode 750003 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Tapan Biswas |
Medical ICU, Critical Care Medicine |
Department Of CCM,IMS and SUM Hospital, Kalinga Nagar, Bhubaneswar, PIN 751003
Khordha
ORISSA |
9830747182
tapan.biswas75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, IMS and SUM Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All the patients admitted to ICU above 18years. |
|
| ExclusionCriteria |
| Details |
1. Those who are die within 24hors
2. Those who are shifted out within 24hours
3. Those who are agreed to give consent for this study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare over-stay between two groups namely free health care group versus conventional group/paid group
2. To compare the length of ICU stay between two groups |
4weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.TO compare the average APACHE score between two group
2. To compare daily SOFA score between two groups
3. To compare ICU mortality rate between the two groups. |
At 4weeks |
|
|
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)
|
10/06/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response (Others) - all the data
- What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
Response (Others) - study protocol
- Who will be able to view these files?
Response (Others) - any one
- For what types of analyses will this data be available?
Response (Others) - any purpose
- By what mechanism will data be made available?
Response - Proposals should be directed to [tapan.biswas75@gmail.com].
- For how long will this data be available start date provided 30-04-2025 and end date provided 30-04-2026?
Response (Others) - after the publications
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - no
|
|
Brief Summary
|
ICU is a highly specialized part of a hospital where very sick patients are treated. ICUs have the capacity to provide
immediate, lifesaving care to patient and without this care patient may die
immediately or eventually. Care of
critically ill patients is an integral part of hospital care, but
ICU beds are not only limited
but also a costly resource, specially in a populous country like
India. It is a matter of concern that
during covid pandemic, many patients died due to unavailability of ICU
beds. It has also been observed that not
only in pandemic but also in others times,
there is unavailability of ICU beds. A 10 day pilot study conducted
in" IMS and Sum hospital" found that there was an average15 refusal per day(1).
This ICU bed scarcity might have occured
because of patients who could have been managed in intermidiatary set ups,
were probably occupying the ICU bed.
A10 day pilot study conducted found that
10% of patient |