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CTRI Number  CTRI/2021/01/030581 [Registered on: 19/01/2021] Trial Registered Prospectively
Last Modified On: 12/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Effect of process of securing airway in head injury patients due to trauma on the occurence of Ventilator associated lung infection 
Scientific Title of Study   Correlation between prior airway management and incidence of Ventilator Associated Pneumonia in traumatic brain injury patients : A prospective observational study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mahizhan K A 
Designation  Junior Resident 
Affiliation  PGIMER Chandigarh  
Address  Department of Anaesthesia and Intensive Care, 4th floor, A block, Nehru Hospital, PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  mahizhan2014@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kajal Jain 
Designation  Professor 
Affiliation  PGIMER, Chandigarh  
Address  Room No. 33 Faculty offices, D Block, Level 2, Nehru Hospital, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  kajalteji@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mahizhan K A 
Designation  Junior Resident 
Affiliation  PGIMER Chandigarh  
Address  Department of Anaesthesia and intensive Care, Level 4, A block, Nehru Hospital, PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  mahizhan2014@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh 
 
Primary Sponsor  
Name  PGIMER 
Address  PGIMER, Sector 12, Chandigarh 
Type of Sponsor  Research institution and hospital 
 
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 Mahizhan K A   Post Graduate Institute of Medical Education and Research, Chandigarh  Trauma ICU level 3 ATC complex
Chandigarh
CHANDIGARH 
9489810511

mahizhan2014@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, PGIMER, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J17||Pneumonia in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All patients more than or equal to eighteen years of age admitted with severe TBI (GCS eight or less)
Patients with device used to support assist or control respiration by the application of positive pressure to the airway delivered through an artificial airway (oral or nasal endotracheal or tracheostomy tube)
Duration of mechanical ventilation in Trauma ICU more than or equal to forty eight hours
 
 
ExclusionCriteria 
Details  Patients who expire in less than forty eight hours of mechanical ventilation
Patients who refuse consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To co-relate characteristics of prior airway management (pre-hospital and in-hospital at triage/operation theatre/ward) with development of Ventilator Associated Pneumonia (for the time the patient is admitted in ICU) in patients with severe Traumatic Brain Injury receiving critical care  Daily, till discharge of patient from ICU 
 
Secondary Outcome  
Outcome  TimePoints 
1.Days of mechanical ventilation
2.ICU length of stay
3.ICU mortality
4.Hospital length of stay
5.Ventilator free days (VFD) 
Daily till discharge of patient from ICU
Till discharge from hospital 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   01/02/2021 
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 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  

Ventilator-associated pneumonia (VAP) is a pneumonia that occurs in a hospitalized patients who have received more than 48 hours of mechanical ventilation (MV), presenting with Xray evidence of new or progressive infiltrate or consolidation, along with associated symptoms, signs and laboratory investigations. The incidence of VAP in traumatic brain injury (TBI) patients was reported to be significantly high , ranging between 24% to 60% and  was shown to be associated with early death and higher mortality, especially in patients with a GCS less than or equal to  8. Apart from contributing to a greater proportion of death and disability, the treatment and increased hospital length of stay leads to a significant economic burden worldwide. 

Following head injury, a cascade of primary and secondary insults is initiated inducing significant morbidity in these patients. The primary insults include brain parenchyma injury, deranged cerebral metabolism, changes in cerebral blood flow with consequent cerebral edema which cannot be averted. Among the devastating secondary insults, depressed level of consciousness, airway obstruction, inability to clear mucus secretions and loss of protective airway reflexes are potential factors known to increase the risk of aspiration and other pulmonary related complication in critical head injury patients. Of note, a recent data has related trauma induced factors like full stomach, pain, agitation, facio-maxillary injuries, cervical spine immobilization and prehospital airway management as adjunctive causes accounting for early onset pneumonia in patients receiving critical care.

In lower middle income countries like ours, prehospital airway management is negligible and hence on arrival to Emergency Room, the airway characteristics of these TBI patients are mostly compromised. The implications of trauma, prehospital / triage airway management and its association with VAP have not been investigated so far in our settings. Also most of the data in literature on prehospital airway management has been done retrospectively. This study design intends to observe prior airway characteristics and co-relate the incidence of VAP in patients admitted to our trauma intensive care following severe head injury.  The diagnosis of VAP follows the American Thoracic Society (ATS) definition and will be confirmed by microbiological culture. 


 
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