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CTRI Number  CTRI/2022/09/045768 [Registered on: 22/09/2022] Trial Registered Prospectively
Last Modified On: 20/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective observational 
Study Design  Single Arm Study 
Public Title of Study   Study on ventilator associated pneumonia  
Scientific Title of Study   A Study on Clinico-Microbiological Observations in cases of Ventilator associated pneumonia Admitted in ICU of Tertiary Care Center:An observational study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ravi Chaudhary 
Designation  Junior Resident 
Affiliation  AIIMS , Rishikesh 
Address  Virbhadra road,shivaji nagar, near barrage,rishikesh, uttarakhand

Dehradun
UTTARANCHAL
249203
India 
Phone  8853419492  
Fax    
Email  Ravichaudhary8080@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ankit Agarwal  
Designation  Additional professor  
Affiliation  AIIMS , Rishikesh 
Address  Virbhadra road,shivaji nagar, near barrage,rishikesh, uttarakhand

Dehradun
UTTARANCHAL
249203
India 
Phone  8475000280  
Fax    
Email  ankit.anaes@aiimsrishikesh.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Ravi Chaudhary 
Designation  Junior Resident 
Affiliation  AIIMS , Rishikesh 
Address  Virbhadra road,shivaji nagar, near barrage,rishikesh, uttarakhand


UTTARANCHAL
249203
India 
Phone  8853419492  
Fax    
Email  Ravichaudhary8080@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Rishikesh  
 
Primary Sponsor  
Name  AIIMS Rishikesh  
Address  Virbhadra road,shivaji nagar,near barrage,rishikesh, uttarakhand  
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 = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ravi Chaudhary   AIIMS Rishikesh   Department of anaesthesiology/ICU/floor 6
Dehradun
UTTARANCHAL 
8853419492

Ravichaudhary8080@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee, AIIMS, Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Admitted to ICU and intubated for ≥ 48 hrs 
 
ExclusionCriteria 
Details  Community Acquired Pneumonia
2. Pre-existing pneumonia
3. Pregnancy
4. Immunocompromised patients
5. Patient / attendant refusing to give consent for participating in study 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Total number of VAP cases   One year 
 
Secondary Outcome  
Outcome  TimePoints 
Organism isolated along with frequency
Antibiotic sensitivity/resistance pattern
Length of ICU stay
Total patient turnover/day before sampling
Number of staff available
Outcome (discharge/death) 
Frequency sensitivity duration length 
 
Target Sample Size   Total Sample Size="101"
Sample Size from India="101" 
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)   24/09/2022 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
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 major cause of morbidity and mortality in any Intensive Care Unit (ICU) despite recent advances in diagnosis and accuracy of management. VAP is also the most frequent ICU acquired infection. In 2015 CDC conducted a point-prevalence survey in a sample of acute care hospitals in U.S. and determined that of the 427 health care–associated infections identified, pneumonia was the most common infection with 32% of those being ventilator associated. Early-onset VAP is usually less severe, associated with a better prognosis, and is more likely to be caused by antibiotic-sensitive bacteria. Late-onset VAP, is usually caused by multi-drug resistant (MDR) pathogens and is associated with increased morbidity and mortality. Many studies from India have investigated the causative organisms of VAP. Pseudomonas spp., Acinetobacter spp., E.coli , Klebsiella pneumoniae, and Staphylococcus aureus were identified as the common VAP pathogens, with varying prevalence. Up to 40% of these infections can be polymicrobial. Pseudomonas spp., Acinetobacter spp.and,even Enterobacteriaceae are quite often MDR. Therefore, the local microbial flora causing VAP needs to be studied in each setting to guide more effective and rational utilization of antimicrobial agents.

 

For the last few decades, hospitals have taken the hospital-acquired infections seriously. Several hospitals have established infection tracking and surveillance systems in place, along with robust prevention strategies to reduce the rate of hospital-acquired infections. The impact of hospital-acquired infections is seen not just at an individual patient level, but also at the community level as they have been linked to multidrug-resistant infections. Identifying patients with risk factors for hospital-acquired infections and multidrug-resistant infections is very important in the prevention and minimization of these infections. 

 

So for there is scanty literature about prevalence, bacteriology, and antibiotic susceptibility pattern about VAP in India. Although mechanical ventilation (MV) is a life-saving intervention, it has its own potential complications. Newer antibiotics in the past decade have not brought down the mortality in the critical care facilities across the world, associated with VAP. The increasing incidence, mortality, MDR pathogens of VAP in Critical Care Units are the main challenges prompting for this study. The main concerns are to determine the prevalence, bacteriology, local antibiotic susceptibility, and resistance pattern including MDR isolates, risk factors, and outcome of VAP at a tertiary care institute.

As per CDC/NHSN guidelines ,

Pneumonia (PNEU) is identified by using a combination of imaging, clinical and laboratory criteria.

Ventilator: Any device used to support, assist, or control respiration (inclusive of the weaning period) through the application of positive pressure to the airway when delivered via an artificial airway, specifically an oral/nasal endotracheal or tracheostomy tube.

Ventilator-associated pneumonia (VAP): A pneumonia where the patient is on mechanical ventilation for > 2 consecutive calendar days on the date of event, with day of ventilator placement being Day 1,*

AND

the ventilator was in place on the date of event or the day before.

*If the ventilator was in place prior to inpatient admission, the ventilator day count begins with the admission date to the first inpatient location.

If a break in mechanical ventilation occurs for at least one full calendar day, ventilator day count for ventilator association starts anew upon reintubation and/or re-initiation of mechanical ventilation.
 
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