| CTRI Number |
CTRI/2025/01/079436 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
incidence of lung infection due to mechanical ventilator in the ICU patients, those who are ventilator |
|
Scientific Title of Study
|
incidence of ventilator-associated pneumonia (VAP) in tertiary care icu in central india:retrospective cohort 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 |
Dr Hari Shankar Gupta |
| Designation |
HOD critical care unit |
| Affiliation |
VIMS hospital |
| Address |
vims hospital , lic chowck Mohan Nagar,nagpur
Nagpur
MAHARASHTRA
440001
India |
| Phone |
09890924509 |
| Fax |
|
| Email |
drharishankargupta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hari Shankar Gupta |
| Designation |
HOD critical care unit |
| Affiliation |
VIMS hospital |
| Address |
vims hospital , lic chowck Mohan Nagar,nagpur
Nagpur
MAHARASHTRA
440001
India |
| Phone |
09890924509 |
| Fax |
|
| Email |
drharishankargupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitin Khandelwal |
| Designation |
critical care cunsultant |
| Affiliation |
VIMS Hospital |
| Address |
vims hospital ,lic chowck ,mohan nagar ,nagpur
Nagpur
MAHARASHTRA
440001
India |
| Phone |
9823109993 |
| Fax |
|
| Email |
knits74@gmai.com |
|
|
Source of Monetary or Material Support
|
| VIMS hospital critical care unit nagpur |
|
|
Primary Sponsor
|
| Name |
VIMS Hospital Nagpur |
| Address |
vims hospital ,lic chowck,mohan nagar,nagpur |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| hari shankar gupta |
vims hospital |
vims Hospital, Lic Chowck, Mohan Nagar, Nagpur
Nagpur
MAHARASHTRA |
09890924509
drharishankargupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee of vims |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
14.00 Day(s) |
| Age To |
80.00 Day(s) |
| Gender |
Both |
| Details |
all patient admitted to icu on invasive mechanical ventilator for more than 2 days, non-pregnant woman , |
|
| ExclusionCriteria |
| Details |
age less then 14 years, pregnant woman, patient transfer in from another hospital on invasive mechanical ventilator, |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in incidence of ventilator associated pneumonia |
24 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| mortility benifit |
24 month |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
10/02/2025 |
| 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="0"
Months="0"
Days="10" |
|
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
|
We have retrospectively collected data from 106 patients from the tertiary care ICU who are mechanically ventilated for more than 2 days. Our data show a significant low incidence of ventilator-associated pnemonia as compared with existing litrature . in our study, we use minimal o2 or no o2 supplementation to maintain spo2 level more than 92%. As per our strategy, most of our patients maintain spo2 92% with fio2 0.21 only. |