| CTRI Number |
CTRI/2023/01/048941 [Registered on: 12/01/2023] Trial Registered Prospectively |
| Last Modified On: |
11/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A study done to assess the occurrence of pneumonia among head injury patients on ventilatory support |
|
Scientific Title of Study
|
A retrospective cohort study evaluating the incidence of ventilator associated
pneumonia in adult patients with traumatic brain injury in a tertiary care centre in central Kerala |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Moses Reji Chandy |
| Designation |
MBBS Student |
| Affiliation |
MOSC Medical College Hospital, Kolenchery |
| Address |
MOSC MEDICAL COLLEGE HOSPITAL, KOLENCHERY PO, ERNAKULAM
THOTTATHIL, PANDALAM PO, KADAKKAD, KURAMPALA, PATHANAMTHITTA, KERALA
689501
Ernakulam
KERALA
682311
India |
| Phone |
9947517316 |
| Fax |
|
| Email |
moseschandy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sam Philip |
| Designation |
Anaesthesiologist |
| Affiliation |
MOSC Medical College Hospital, Kolenchery |
| Address |
MOSC MEDICAL COLLEGE HOSPITAL, KOLENCHERY PO, ERNAKULAM
Ernakulam
KERALA
682311
India |
| Phone |
9447209010 |
| Fax |
|
| Email |
drsam_p@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sam Philip |
| Designation |
Anaesthesiologist |
| Affiliation |
MOSC Medical College Hospital, Kolenchery |
| Address |
MOSC MEDICAL COLLEGE HOSPITAL, KOLENCHERY PO, ERNAKULAM
Ernakulam
KERALA
682311
India |
| Phone |
9447209010 |
| Fax |
|
| Email |
drsam_p@hotmail.com |
|
|
Source of Monetary or Material Support
|
| MOSC Medical College Hospital, Kolenchery, Kerala |
|
|
Primary Sponsor
|
| Name |
MOSC Medical College Hospital |
| Address |
Kolenchery Medical College Junction, Kolenchery, Ernakulam, Kerala 682311 |
| Type of Sponsor |
Private medical college |
|
|
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 Sam Philip |
MOSC Medical College Hospital |
Department of Anaesthesiology & Critical Care, Kolenchery, Ernakulam, Kerala 682311
Ernakulam
KERALA |
9447209010
drsam_p@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J189||Pneumonia, unspecified organism, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All traumatic brain injury adult patients intubated within the hospital |
|
| ExclusionCriteria |
| Details |
Traumatic brain injury patients intubated in other hospitals, traumatic brain injury patients with pre-existing lung pathology are excluded |
|
|
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 ventilator associated pneumonia in traumatic brain injury patients |
In the last 2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the most common causative organism of ventilator associated pneumonia in traumatic brain injury. |
In the last 2 years |
| To analyze the antimicrobial susceptibility and evaluate the prognosis of the traumatic brain injury patients. |
In the last 2 years |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
14/01/2023 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a retrospective cohort study evaluating the incidence of ventilator associated pneumonia in adult patients with traumatic brain injury in a tertiary care centre in Central Kerala. The primary objective or outcome is to estimate the incidence of ventilator associated pneumonia in traumatic brain injury. Other objectives are to determine the most common causative organism of ventilator associated pneumonia in traumatic brain injury and to analyze the antimicrobial susceptibility and evaluate the prognosis of the patients. |