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
|
|
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
|
|
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
|
|
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
|
|
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. |