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CTRI Number  CTRI/2017/04/008290 [Registered on: 05/04/2017] Trial Registered Prospectively
Last Modified On: 03/04/2017
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Infection rate in tracheostomized traumatic brain injured patients, if tube changed early on 4th day or late on 7th day.  
Scientific Title of Study   To compare the effect of early vs. late tracheostomy tube change on the incidence of infection in Traumatic Brain Injury patients in ICU. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Yashpal Singh 
Designation  Assistant Professor 
Affiliation  Institute of Medical Sciences, Banaras Hindu University, Varanasi 
Address  Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi Varanasi UTTAR PRADESH 221005 India

Varanasi
UTTAR PRADESH
221005
India 
Phone  919918424416  
Fax    
Email  dryashacin1999@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Yashpal Singh 
Designation  Assistant Professor 
Affiliation  Institute of Medical Sciences, Banaras Hindu University, Varanasi 
Address  Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi Varanasi UTTAR PRADESH 221005 India


UTTAR PRADESH
221005
India 
Phone  919918424416  
Fax    
Email  dryashacin1999@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Yashpal Singh 
Designation  Assistant Professor 
Affiliation  Institute of Medical Sciences, Banaras Hindu University, Varanasi 
Address  Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi Varanasi UTTAR PRADESH 221005 India


UTTAR PRADESH
221005
India 
Phone  919918424416  
Fax    
Email  dryashacin1999@rediffmail.com  
 
Source of Monetary or Material Support  
Trauma Center,Institute of Medical Sciences, Banaras Hindu University 
 
Primary Sponsor  
Name  None 
Address  None 
Type of Sponsor  Other [None] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Yashpal Singh  Banaras Hindu University  Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi Varanasi UTTAR PRADESH 221005 India
Varanasi
UTTAR PRADESH 		 919918424416

dryashacin1999@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institunal Ethical Commette, Faculty of Medicine, IMS, BHU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Tracheostomized head injury patient in trauma ICU, both male and female patients undergoing tracheostomy tube change according to ICU protocol.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Head injury patients on tracheostomy tube.
2.Age group between 18 and 60 years.
 
 
ExclusionCriteria 
Details  1.Patients on immunosuppressant’s.
2.Patients transferred from other ICU.
3.Pregnancy.
4.History of allergy to PVC materials.
5.Patient refusal to participate in the study.
6.Patient on adrenoreceptor agonist or antagonist therapy.
7.Uncontrolled medical disease (diabetes mellitus and hypertension).
8.Patient already in sepsis.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of infection  Group E 7,11,15 day
Group L 7,14,21 day 
 
Secondary Outcome  
Outcome  TimePoints 
Type of micro-organism isolated.  Group E 7,11,15 days
Group L 7,14,21 days 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   18/04/2017 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not yet. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Respiratory tract infections are the most common nosocomial infections encountered in ICU patients. Common source of these infections are indwelling tubes and catheters. Despite of the aseptic and hygiene practices by the ICU staff there has been only a moderate decrease in the infection rate.In  earlier studies tube were changed after 7 days. Biofilms are formed within 7 days of insertion but colonization begins as early as 12 hr and most abundant in 96 hr.  So we hypothesized that changing of tracheostomy tube within 96 hr to prevent further biofilm formation and reduces subsequent acquired infection.
After obtaining written informed consent from patient guardian or relative,  patients will be divided randomly into two groups (n=40): Group E tracheostomy tube changed on every 4th day; Group L tracheostomy tube will be changed on every 7th day. Baseline parameter of infection like fever, TLC and culture report  are documented. Tracheal aspirate culture will be send before tube change along with culture of blood, urine or any other potential source of infection. Any raise in temperature and TLC will be documented. Antibiotcs will be changed based on culture and sensitive report.
 
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