| CTRI Number |
CTRI/2021/12/038480 [Registered on: 07/12/2021] Trial Registered Prospectively |
| Last Modified On: |
03/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To estimate the number of people getting lung infection after getting mechanical ventilation in a medical college and its overall impact in public health. |
|
Scientific Title of Study
|
Estimation of the incidence and microbial profile of ventilator associated pneumonia in a tertiary care centre and its implication in health care system. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandeep Dey |
| Designation |
Senior Resident (Registrar) of Anaesthesiology |
| Affiliation |
Jorhat Medical College |
| Address |
Department of Anaesthesiology
Jorhat Medical College
Jorhat
ASSAM
785001
India |
| Phone |
|
| Fax |
|
| Email |
sandeep.dey09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Binita Bhuyan |
| Designation |
Senior Resident of Microbiology |
| Affiliation |
Jorhat Medical College |
| Address |
Department of Microbiology
Jorhat Medical College
Jorhat
ASSAM
785001
India |
| Phone |
|
| Fax |
|
| Email |
bntbhuyan15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Dey |
| Designation |
Senior Resident (Registrar) of Anaesthesiology |
| Affiliation |
Jorhat Medical College |
| Address |
Department of Anaesthesiology
Jorhat Medical College
Jorhat
ASSAM
785001
India |
| Phone |
|
| Fax |
|
| Email |
sandeep.dey09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central medical store.
Jorhat Medical College
Jorhat, Assam, India |
|
|
Primary Sponsor
|
| Name |
Dr Sandeep Dey |
| Address |
Department of Anesthesiology
Jorhat Medical College
Jorhat, Assam |
| Type of Sponsor |
Other [Principal investigator] |
|
|
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 |
| Dr Sandeep Dey |
Jorhat Medical College |
General and Covid ICU
Jorhat Medical College
Jorhat, Assam.
Jorhat
ASSAM |
9864871305
sandeep.dey09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee (H), Jorhat Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J962||Acute and chronic respiratory failure, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients more than 18 years where consent was obtained from responsible attendant/guardian.
2. Patient mechanically ventilated for at least more than 48 hours. |
|
| ExclusionCriteria |
| Details |
1. Patients less than 18 years or where no consent was obtained.
2. Intubation done outside our ICU set up.
3. Patients with some other definite source of infection.
4.Immune compromised states.
5. Patients with low GCS and were on NIV support prior to being referred to our set up.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of ventilator associated pneumonia (VAP) |
48 hours after mechanical ventilation and after 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the microbial etiology of VAP |
After 6 months |
|
|
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)
|
12/12/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
The trial will give us a data about the incidence and microbial profile of ventilator associated pneumonia in a tertiary care set up. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A cross sectional observational study will be carried out in the Intensive Care Units (Covid and Non Covid) of Jorhat Medical College and Hospital, Jorhat. All patients enrolled in the study will be followed daily for the development of signs and symptoms of VAP 48 hours after intubation and mechanical ventilation. Various clinical, physiological, microbiological and radiographic parameters, as described by Johanson et al., will be accessed giving them numerical values, which when scored can predict the presence or absence of VAP. In a case of new onset sepsis, tracheal aspirate will be collected using sterile mucus extractor and as par CDC guidelines for collection of tracheal aspirate sample.. Attempt to exclude other sources of infection will be made by focused physical examination and relevant investigations including urine culture, blood culture, imaging studies etc. depending upon the clinical profile of the patient. . If no other apparent source of infection will be found, then VAP will be suspected and lung protective ventilation as par ARDS net protocol will be started to prevent the development of ARDS. All samples will be processed in the department of microbiology for the growth of organisms by conventional methods. All isolates will be subjected to antimicrobial sensitivity testing using disk diffusion method Following CLSI guidelines |