| CTRI Number |
CTRI/2018/01/011106 [Registered on: 02/01/2018] Trial Registered Prospectively |
| Last Modified On: |
02/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison Of Incidence Of Lung Infections Caused Due To Ventilator In Patients With Early Tracheostomy(making a hole in wind pipe and inserting tube) Against Those Who Underwent Late Tracheostomy |
|
Scientific Title of Study
|
Incidence Of Ventilator Associated Pneumonia In Early Tracheostomy Versus Late Tracheostomy In Critically Ill Patients:A Randomized Controlled Comparative Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sumit mishra |
| Designation |
MD Trainee |
| Affiliation |
Indira Gandhi Institute Of Medical Sciences, Patna |
| Address |
C/o AK Mishra, Road no.1,Vivek Vihar, Hanuman Nagar, Kankarbagh, Patna
Patna
BIHAR
800020
India |
| Phone |
9199667276 |
| Fax |
|
| Email |
smishra089@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjeev Kumar |
| Designation |
Additional Professor |
| Affiliation |
|
| Address |
D-5/4
IGIMS Campus, Patna
Patna
BIHAR
800014
India |
| Phone |
|
| Fax |
|
| Email |
sanjeev_pranay71@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sumit mishra |
| Designation |
MD Trainee |
| Affiliation |
Indira Gandhi Institute Of Medical Sciences, Patna |
| Address |
C/o AK Mishra, Road no.1,Vivek Vihar, Hanuman Nagar, Kankarbagh, Patna
Patna
BIHAR
800020
India |
| Phone |
9199667276 |
| Fax |
|
| Email |
smishra089@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute Of Medical Sciences, Patna |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Institute Of Medical Sciences |
| Address |
Sheikhpura, Patna, Bihar |
| 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 |
| Sumit Mishra |
Indira Gandhi Institute Of Medical Sciences,Patna |
Sheikhpura, Patna, Bihar
Patna
BIHAR |
9199667276
smishra089@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee,Igims,patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Critically Ill Patients , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Early tracheostomy |
The timing of early tracheostomy will be within 3 days of intubation.tracheal aspirates will be taken within 24,48 and 96 hrs. |
| Comparator Agent |
Late tracheostomy |
The late tracheostomy will be tracheostomy after 5 days of intubation.tracheal aspirates will be taken in same manner as intervention group. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged more than 20 years and less than sixty years
Intubated patients with ventilatory support of more than 48 hours |
|
| ExclusionCriteria |
| Details |
Patients aged less than 20 years and more than 60 years
Any neck mass or swelling in neck
Outside intubated or tracheostomised patients
Patient in need of isolation like tuberculosis, Hepatitis-B, Hepatitis-c,HIV 1 and 2 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of VAP in both groups and assessment of severity through CPIS scale |
endotracheal samples taken at 24,48 and 96 hrs of intubation and sent for culture |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to VAP diagnosis
Mortality rate
Duration of ICU stay |
During ICU stay |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/01/2018 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Ventilator associated pneumonia has a significant role in morbidity and mortality of patients of intensive care unit,who are on tracheostomy and put on ventilatory support.In spite of several precautionary measures, the incidence of VAP in ICU patients is still high and has great impact on their outcome.Through this study we would like to compare the incidence of VAP in critically ill patients with early versus late tracheostomy who need prolonged ventilatory support for various type of illness. |