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临床试验/CTRI/2025/04/086045
CTRI/2025/04/086045尚未招募不适用

Incidence of Ventilator-Associated Pneumonia, it’s Clinico-Microbiological profile & Antibiotic Sensitivity Patterns inmechanically ventilated ICU patients - A prospective observational study.

Sanjay Gandhi Postgraduate Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年10月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
To study the incidence of VAP and its microbiological profiling from the endotracheal isolate of mechanically ventilated ICU patients.

研究概览

简要总结

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).

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Adult patients of both gender staying in ICU for more than 48 hours after endotracheal intubation.

排除标准

  • 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.

结局指标

主要结局

To study the incidence of VAP and its microbiological profiling from the endotracheal isolate of mechanically ventilated ICU patients.

时间窗: 24 hours , 72 to 96 hours , after 96 hours twice weekly sampling

次要结局

  • 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).)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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