CTRI

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CTRI Number

CTRI/2025/04/086045 [Registered on: 30/04/2025] Trial Registered Prospectively

Last Modified On:

29/04/2025

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Follow Up Study

Study Design

Other

Public Title of Study

Incidence of Ventilator-Associated Pneumonia, it’s Clinico-Microbiological profile & Antibiotic Sensitivity Patterns in Mechanically Ventilated ICU Patients

Scientific Title of Study

Incidence of Ventilator-Associated Pneumonia, it’s Clinico-Microbiological profile & Antibiotic Sensitivity Patterns in mechanically ventilated ICU patients - A prospective observational 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	Puneet Goyal
Designation	Professor
Affiliation	Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow
Address	Department of Anaesthesiology Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow Uttar Pradesh 226014 India Lucknow UTTAR PRADESH 226014 India
Phone	8004904597
Fax
Email	princeofcoma@yahoo.co.uk

Details of Contact Person
Scientific Query

Name	Puneet Goyal
Designation	Professor
Affiliation	Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow
Address	Department of Anaesthesiology Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow Uttar Pradesh 226014 India UTTAR PRADESH 226014 India
Phone	8004904597
Fax
Email	princeofcoma@yahoo.co.uk

Details of Contact Person
Public Query

Name	Puneet Goyal
Designation	Professor
Affiliation	Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow
Address	Department of Anaesthesiology Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow Uttar Pradesh 226014 India UTTAR PRADESH 226014 India
Phone	8004904597
Fax
Email	princeofcoma@yahoo.co.uk

Source of Monetary or Material Support

Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow Uttar Pradesh 226014 India

Primary Sponsor

Name	Sanjay Gandhi Postgraduate Institute of Medical Sciences
Address	Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow Uttar Pradesh 226014 India
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 2
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Esha Kujur	Sanjay Gandhi Postgraduate Institute of Medical Sciences	Department of Anaesthesiology Main Post op ICU PMSSY Post op ICU ATC ICU SGPGI Campus Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow Uttar Pradesh 226014 India Lucknow UTTAR PRADESH	8884963766 esha.v.kujur@gmail.com
Dr Puneet Goyal	Sanjay Gandhi Postgraduate Institute of Medical Sciences	Department of Anaesthesiology Sanjay Gandhi Postgraduate Institute of Medical Sciences SGPGI Campus Lucknow Uttar Pradesh 226014 India Lucknow UTTAR PRADESH	8004904597 princeofcoma@yahoo.co.uk

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Comittee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

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	18.00 Year(s)
Age To	90.00 Year(s)
Gender	Both
Details	Adult patients of both gender staying in ICU for more than 48 hours after endotracheal intubation.

ExclusionCriteria

Details

Negative consent.
Patients admitted to ICU with ETT in situ prior admission.
Patients who are immunocompromised and or on immunosuppressant drugs.
Patients with pre-existing pneumonia, aspiration pneumonitis, ARDS, pulmonary edema and CHF.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To study the incidence of VAP and its microbiological profiling from the endotracheal isolate of mechanically ventilated ICU patients.	24 hours , 72 to 96 hours , after 96 hours twice weekly sampling

Secondary Outcome

Outcome

TimePoints

1.To find out the antibiotic susceptibility and sensitivity patterns of the microorganisms isolated and identified in our study.

2.To determine different risk factors in critically ill ICU patients who are on mechanical ventilator support with respect to VAP (Ventilator Associated Pneumonia).

3.To determine, difference between microbiological profile and sensitivity pattern between early and late onset Ventilator Associated Pneumonias.

24 hours , 72 to 96 hours , after 96 hours twice weekly sampling

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)

10/05/2025

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="6"
Days="0"

Recruitment Status of Trial (Global)

Open to Recruitment

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

Type of Study: Prospective Observational Study.

Objective: To determine the incidence, clinical and microbiological profile, and antibiotic sensitivity patterns of ventilator-associated pneumonia (VAP) in ICU patients.

Background

VAP is the most common hospital acquired infection in ICU settings.

In India, gram-negative resistant organisms are increasingly responsible for VAP.

Despite growing antimicrobial resistance, VAP epidemiology in India remains underreported.

Aims and Objectives

1. Assess VAP incidence in mechanically ventilated ICU patients.

2. Analyze clinical presentation, microbiological findings, and antibiotic sensitivity.

3. Evaluate clinical response and ICU course.

Methodology

Study Setting: Three ICUs in Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGI): Main Post Op ICU, Apex Trauma Centre ICU, PMSSY ICU.

Sample: Minimum of 100 adult ICU patients intubated for more than 48 hours.

Exclusions: Patients from outside SGPGI, immunocompromised, or with pre-existing lung conditions (pneumonia, ARDS, CHF).

ETT Culture Timeline: Within 24 hours of intubation.

Between 72–96 hours.

Biweekly thereafter ( after 96 hours).