| CTRI Number |
CTRI/2024/06/069371 [Registered on: 21/06/2024] Trial Registered Prospectively |
| Last Modified On: |
15/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational |
| Study Design |
Other |
|
Public Title of Study
|
Complications of the invasive procedures in Intensive care unit. |
|
Scientific Title of Study
|
An observational prospective study on complications related to invasive procedures done in ICU.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
R Monika |
| Designation |
Post graduate student |
| Affiliation |
Sri Ramachandra Institute of Higher education and Research |
| Address |
Department of critical care medicine
M.SC Critical Care Technology
Sri Ramachandra Institute Of Higher education and Research
Porur
Chennai-600116
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
7708284040 |
| Fax |
|
| Email |
monipooja2412@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Baby Sailaja K |
| Designation |
Associate professor |
| Affiliation |
Sri Ramachandra Institute of Higher education and Research |
| Address |
Associate professor
Department of critical care medicine
Sri Ramachandra institute of higher education and research
Porur
Chennai
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
9600159482 |
| Fax |
|
| Email |
babysailaja.k@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr MK Renuka |
| Designation |
Professor and Head of department |
| Affiliation |
Sri ramachandra institute of higher education and research |
| Address |
Department of critical care medicine
Sri Ramachandra Institute of Higher education and Research
Porur
Chennai.
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
8056126336 |
| Fax |
|
| Email |
renuka.mk@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra institute of higher education and research.
Porur
Chennai-600116
Tamil Nadu
India. |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of higher education and research |
| Address |
Department of critical care medicine
M.SC Critical Care Technology
Porur
Chennai-600116 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Baby Sailaja K |
Sri Ramachandra Institute of higher education and research |
Department of critical care medicine
Porur
Chennai-600116
Thiruvallur
TAMIL NADU |
9600159482
babysailaja.k@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patient in ICU requiring invasive procedures |
|
| ExclusionCriteria |
| Details |
Any invasive procedure done to the patient outside the ICU and shifted to Critical care ICU.
Complications which occurred because of the procedure, but not due to the underlying disease condition.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing the complications within 24 hours of procedure. |
six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mortality of patients secondary to invasive procedure. |
six months. |
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
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)
|
15/07/2024 |
| 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 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
|
Critically ill and hospitalized patients often require invasive
procedures as a part of their medical care.
Each procedure carries a set of risks and associated complications
which can affect the cost, ICU length of stay.
Central venous catheterization, arterial catheterization, pleural
tapping, ascitic tapping, tracheostomy, intercoastal drainage, and lumbar puncture
constitute a majority of the procedures performed in hospitalized ICU patients.
In this study we are planning to observe the rate of
complications associated with invasive procedures performed in Critical care
unit within 24 hours of procedure. |