| CTRI Number |
CTRI/2025/07/090202 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Tracking Infections in the ICU. A Closer Look at Ventilator Associated Pneumonia |
|
Scientific Title of Study
|
Incidence and Consequences of Ventilator Associated Pneumonia. An Observation 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 |
MAHIMA L N |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
MD |
| Address |
Shri chennakeshava Swamy Nilaya, Nisarga Layout, Hoskote
MVJ Medical College, Hoskote
Bangalore
KARNATAKA
562114
India |
| Phone |
9108936169 |
| Fax |
|
| Email |
mahi.mahima30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MAHIMA L N |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
MD |
| Address |
Shri chennakeshava Swamy Nilaya, Nisarga Layout, Hoskote
MVJ Medical College, Hoskote
Bangalore
KARNATAKA
562114
India |
| Phone |
9108936169 |
| Fax |
|
| Email |
mahi.mahima30@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MAHIMA L N |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
MD |
| Address |
Shri chennakeshava Swamy Nilaya, Nisarga Hi Tec Layout, Hoskote
MVJ Medical College, Hoskote
Bangalore
KARNATAKA
562114
India |
| Phone |
9108936169 |
| Fax |
|
| Email |
mahi.mahima30@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
MAHIMA L N |
| Address |
1st floor, OT Complex, MVJ Medical College and Research Hospital, Hoskote |
| Type of Sponsor |
Other [Primary Investigator ] |
|
|
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 |
| MAHIMA L N |
MVJ Medical College and Research Hospital |
First floor, OT Complex, MVJ, Hoskote
Bangalore Rural
KARNATAKA |
9108936169
mahi.mahima30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MVJ Medical College and Research Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I633||Cerebral infarction due to thrombosis of cerebral arteries, (2) ICD-10 Condition: E368||Other intraoperative complicationsof endocrine system, (3) ICD-10 Condition: E663||Overweight, (4) ICD-10 Condition: J90||Pleural effusion, not elsewhere classified, (5) ICD-10 Condition: S069||Unspecified intracranial injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age between 19 to 60, Both Male and Female, Patients receiving mechanical ventilation |
|
| ExclusionCriteria |
| Details |
Patients with pre existing pneumonia
Age more than 60 and less than 19 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence rate of ventilator associated pneumonia per 1000 ventilator days in mechanically ventilated patients during the study period. |
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/08/2025 |
| 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 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 - NO
|
|
Brief Summary
|
Informed consent will be taken. We will be conducting a prospective observational study after Institutional Review Board permission. Data will be collected from medical records of patients who required mechanical ventilation for more than 48 hours. Patients admitted to the ICU who require mechanical ventilation for more than 48 hours will be included. Exclusion criteria will include patients with pneumonia at the time of intubation, those with acute respiratory distress syndrome, and patients who do not survive beyond 48 hours of ventilation. Data Collection Patient demographics, ventilator settings, duration of mechanical ventilation, presence of comorbid conditions, and infection control practices will be recorded. Clinical parameters, laboratory investigations, and microbiological culture results will be analyzed to confirm VAP diagnosis. Data Analysis Incidence rates of VAP will be calculated, and statistical analysis will be performed to identify risk factors. Preventive measures and adherence to ventilator bundle care will also be evaluated.
|