| CTRI Number |
CTRI/2025/11/097442 [Registered on: 14/11/2025] Trial Registered Prospectively |
| Last Modified On: |
13/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Incidence of Ventilator-Associated Pneumonia in a Tertiary Care Centre |
|
Scientific Title of Study
|
Incidence of Ventilator-Associated Pneumonia in a Tertiary Care |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chalamani sai ravindra reddy |
| Designation |
junior resident |
| Affiliation |
Dr DY patil medical college |
| Address |
department of general medicine
Dr DY patil medical college ,navi mumbai ,
Thane
MAHARASHTRA
400706
India |
| Phone |
7397367617 |
| Fax |
|
| Email |
rmchrocks.reddy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Prashant Purkar |
| Designation |
Professor and HOU General Medicine |
| Affiliation |
Dr DY patil medical college , navi mumbai |
| Address |
Department of General Medicine
Dr. D. Y. Patil Medical College, Navi Mumbai, Thane district Maharashtra, 400706, India
Thane
MAHARASHTRA
400706
India |
| Phone |
9892971979 |
| Fax |
|
| Email |
prashpurkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chalamani sai ravindra reddy |
| Designation |
junior resident |
| Affiliation |
Dr DY patil medical college |
| Address |
department of general medicine
Dr DY patil medical college ,navi mumbai ,
Thane
MAHARASHTRA
400706
India |
| Phone |
7397367617 |
| Fax |
|
| Email |
rmchrocks.reddy@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR DY Patil medical college ,Dr DY Patil Vidyanagar sector 5 ,Nerul ,Navi Mumbai, Thane District ,Maharashtra , India , 400706 |
|
|
Primary Sponsor
|
| Name |
Dr Chalamani Sai Ravindra Reddy |
| Address |
Department of general
medicine ,
DR DY Patil medical college ,Dr DY Patil Vidyanagar, sector 5 ,Nerul ,Navi Mumbai, Thane District ,Maharashtra ,
India ,400706 |
| Type of Sponsor |
Other [] |
|
|
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 chalamani sai ravindra reddy |
Dr DY Patil hospital |
Room no 3 ,MICU , department of general medicine ,Dr DY Patil hospital ,Navi Mumbai,
Thane , Maharashtra
Thane
MAHARASHTRA |
7397367617
rmchrocks.reddy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee for biomedical and healty research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J17||Pneumonia in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Both sexes of age more than15 years.
2. On mechanical ventilator more than 48 h.
|
|
| ExclusionCriteria |
| Details |
1. Those died or developed pneumonia within 48 h.
2. Those who are admitted with pneumonia at the time of admission.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • To determine the incidence rate of ventilator-associated pneumonia (VAP) among patients admitted to the Intensive Care Unit (ICU) in a tertiary care hospital. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To identify the common risk factors associated with the development of VAP in mechanically ventilated patients.
2. To study the clinical profile & microbiological spectrum of VAP cases.
3. To evaluate the antibiotic sensitivity pattern of pathogens isolated in VAP cases.
4. To assess the effectiveness of VAP prevention strategies, if implemented, during the study period.
|
1year |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
02/12/2025 |
| 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="2"
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
|
Ventilator-Associated Pneumonia (VAP) is a significant nosocomial infection in patients receiving mechanical ventilation, particularly in intensive care units (ICUs). In tertiary care settings, the incidence of VAP varies widely, typically ranging from 5 to 40 cases per 1,000 ventilator days, depending on local infection control practices, patient comorbidities, and ICU protocols.
Factors contributing to higher incidence in such setups include prolonged mechanical ventilation, invasive procedures, immunosuppression, and inadequate infection control measures. VAP not only increases ICU stay and healthcare costs but is also associated with high morbidity and mortality.
Regular surveillance, adherence to VAP prevention bundles (such as head elevation, daily sedation breaks, oral care with chlorhexidine), and antimicrobial stewardship are crucial to reducing its incidence in tertiary care hospitals. |