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 |
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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 |
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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 |
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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 |
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Primary Sponsor
|
Name |
PGIMER |
Address |
PGIMER, Sector 12, Chandigarh |
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 |
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: J17||Pneumonia in diseases classified elsewhere, |
|
Intervention / Comparator Agent
|
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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 |
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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
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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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