| CTRI Number |
CTRI/2023/10/058331 [Registered on: 05/10/2023] Trial Registered Prospectively |
| Last Modified On: |
27/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Incidence of Ventilator associated pneumonia in ICU in a cancer centre |
|
Scientific Title of Study
|
Incidence and risk factors of Ventilator associated pneumonia in ICU in a tertiary cancer centre: A retrospective 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 |
Sonali Opneja |
| Designation |
Assistant Professor |
| Affiliation |
Malabar Cancer Centre |
| Address |
Room no 1
Operation theatre
Anaesthesia cubicle
Department of Anaesthesia Malabar Cancer Centre
Thalassery
Kannur
KERALA
670103
India |
| Phone |
09765635728 |
| Fax |
|
| Email |
sopneja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sonali Opneja |
| Designation |
Assistant Professor |
| Affiliation |
Malabar Cancer Centre |
| Address |
Room No 1
Operation theatre
Anaesthesia cubicle
Department of Anaesthesia Malabar Cancer Centre
Thalassery
Kannur
KERALA
670103
India |
| Phone |
09765635728 |
| Fax |
|
| Email |
sopneja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sonali Opneja |
| Designation |
Assistant Professor |
| Affiliation |
Malabar Cancer Centre |
| Address |
Room No 1
Operation theatre
Anaesthesia cubicle
Department of Anaesthesia Malabar Cancer Centre
Thalassery
Kannur
KERALA
670103
India |
| Phone |
09765635728 |
| Fax |
|
| Email |
sopneja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Malabar Cancer Centre
Kodiyeri
Thalassery-670103 |
|
|
Primary Sponsor
|
| Name |
Malabar cancer centre |
| Address |
MALABAR CANCER CENTRE
KODIYERI
THALASSERY |
| Type of Sponsor |
Research institution |
|
|
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 Sonali Opneja |
Malabar cancer centre |
Room No 1
Operation theatre
Anaesthesia Cubicle
Department of Anaesthesia
Kannur
KERALA |
09765635728
sopneja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Scientific Review Committee,Instituitional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C390||Malignant neoplasm of upper respiratory tract, part unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients who were intubated for more than 48 hours in ICU from 1stJanuary 2020 to 31stDecember 2022 |
|
| ExclusionCriteria |
| Details |
Patients who were extubated before 48 hours of ICU admission
Patients who already had pneumonia or developed pneumonia within 48 hours of intubation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the incidence of VAP in ICU in a tertiary care centre. |
6 months,1 year,2 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To predict the risk factors associated with VAP. |
6 months,1 year,2 year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/10/2023 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is done to know the incidence and risk factors associated with ventilator associated pneumonia in a cancer institute so that we can better manage such patients. |