| CTRI Number |
CTRI/2022/09/045809 [Registered on: 23/09/2022] Trial Registered Prospectively |
| Last Modified On: |
23/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Patients of Intensive care unit have more chances of infection from each other during treatment.Special trained Infection Control Nurse (ICN) are posted and see wheather affter posting these ICN can decrease infection among patients. |
|
Scientific Title of Study
|
To determine the role of infection control nurse in prevention and control of hospital acquired infection. |
| Trial Acronym |
ICN (Infection Control Nurse) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Zia Arshad |
| Designation |
Additional Professor |
| Affiliation |
KING GEORGES MEDICAL UNIVERSITY, LUCKNOW |
| Address |
Department of Anaesthesiology and Critical Care KGMU, Lucknow
Critical care unit,3rd floor, trauma Centre,KGMU,Lucknow, 226003
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9415722226 |
| Fax |
|
| Email |
ziaarshad13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinod Kumar Srivastava |
| Designation |
Assistant Professor |
| Affiliation |
KING GEORGES MEDICAL UNIVERSITY, LUCKNOW |
| Address |
Department of Anaesthesiology and Critical Care KGMU, Lucknow
Critical care unit,3rd floor, trauma Centre,KGMU,Lucknow, 226003
Lucknow
UTTAR PRADESH
226017
India |
| Phone |
09415795564 |
| Fax |
|
| Email |
vinod123.doctor@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinod Kumar Srivastava |
| Designation |
Assistant Professor |
| Affiliation |
KING GEORGES MEDICAL UNIVERSITY, LUCKNOW |
| Address |
Department of Anaesthesiology and Critical Care KGMU, Lucknow
Critical care unit,3rd floor, trauma Centre,KGMU,Lucknow, 226003
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9415795564 |
| Fax |
|
| Email |
vinod123.doctor@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Deparment Anaesthesiology and Critical care |
| Address |
King Georges Medical University,chowk,Lucknow |
| Type of Sponsor |
Other [Autonomous ] |
|
|
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 Zia Arshad |
King Georges Medical University |
Critical Care Unit(TVU), 3rd Floor, Trauma Centre Department of Anaesthesiology and critical care
Lucknow
UTTAR PRADESH |
9415722226
ziaarshad13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z758||Other problems related to medicalfacilities and other health care, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Infection control nurse posting along with the other doctors and other paramedical staff. |
A trained infection control nurse were posted in ICU along with same doctor and other paramedical staff posted already and see it effect with on patients outcome and comapred with control group of ICU pateints. |
| Comparator Agent |
same doctors and paramedicals staff but not with Infection control nurse(ICN) |
this is basically control groups included those ICU patients who were cared only with presence of doctors and other paramedical staff before posting of ICN. Patients outcome were recored and compared with patients outcome after adding posting of ICN. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All ICU above mentioned age group admitted patients of either sex. |
|
| ExclusionCriteria |
| Details |
patients having pre-existing infection. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Positive blood, tracheal aspirate,urine and other culture |
Time point is after admission in Intensive care Unitwhenever patients come positive documented by culture report. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| incidence of VAP,CAUTI and CLABSI. |
During ICU stay |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
27/09/2022 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Infection rate in ICU is big problem world wide.every possible Measure should have taken to cut down this rate. In this context appointment of Infection control nurse can be of great help in reducing infection rate. The study focus on incidence of positive culture after appointment of ICN .These Data will be compared with previous data of VAP( ventilator associated pneumonia), CAUTI (catheter associated urinary tract infection) AND CLABSI (central line associated blood stream infection) incidence before appointment of ICN ( Infection Control Nurse) |