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CTRI Number  CTRI/2024/11/076604 [Registered on: 11/11/2024] Trial Registered Prospectively
Last Modified On: 10/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   prospective observational study 
Study Design  Other 
Public Title of Study   mechanical power as a predictor of mortality out come in severe traumatic brain injury patients. 
Scientific Title of Study   Mechanical power (MP) as a predictor of outcome in patients with moderate to severe traumatic brain injury (TBI): a prospective observational study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  neeraj kumar 
Designation  senior resident 
Affiliation  King George Medical University 
Address  department of CCM 5th floor trauma center King George Medical University Lucknow
Village Chandipur Post Madhoganj District Hardoi U.P. pin 241302
Hardoi
UTTAR PRADESH
226003
India 
Phone  8601185576  
Fax    
Email  neerajpatel15@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Syed Nabeel Muzaffar  
Designation  Additional professor  
Affiliation  King George Medical University 
Address  department of Critical Care Medicine 5th floor trauma center King George Medical University Lucknow
department of Critical Care Medicine 5th floor trauma center King George Medical University Lucknow
Lucknow
UTTAR PRADESH
226003
India 
Phone  9648084011  
Fax    
Email  muzaffarnabeel@gmail.com  
 
Details of Contact Person
Public Query
 
Name  neeraj kumar 
Designation  senior resident 
Affiliation  King George Medical University 
Address  department of CCM 5th floor trauma center King George Medical University Lucknow
Village Chandipur Post Madhoganj District Hardoi U.P. pin 241302
Hardoi
UTTAR PRADESH
226003
India 
Phone  8601185576  
Fax    
Email  neerajpatel15@gmail.com  
 
Source of Monetary or Material Support  
not applicable 
 
Primary Sponsor  
Name  king georges medical university  
Address  shah meena road chauk lucknow uttar pradesh 226003 
Type of Sponsor  Government medical college 
 
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 
neeraj kumar  King georges medical university  department of CCM 5th floor trauma center
Lucknow
UTTAR PRADESH 
8601185576

neerajpatel15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
king georges medical university U.P   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S069||Unspecified intracranial injury,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients with age ≥18 years
who had sustained an acute brain injury and require invasive ventilation for at least for 24 hours. 
 
ExclusionCriteria 
Details  Pregnancy
Extubation or death within 24 hours
Patient on supportive mode of ventilation
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
28 days mortality in ICU  28 days  
 
Secondary Outcome  
Outcome  TimePoints 
Hospital mortality
90 days mortality
Ventilator induced lung injury (VILI)
 
at any time during hospital stay
90 days
Ventilator induced lung injury (VILI)
 
 
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)   30/11/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

There are different conditions for admission to neuro-critical care (NCC). The most common reason is acute brain injury, which includes traumatic brain injury, subarachnoid hemorrhage, and intracranial hemorrhage. The altered level of sensorium of these individuals necessitates intubation and invasive mechanical ventilation to prevent aspiration and life-threatening consequences, such as hypoxia and hypercapnia. Moreover, patients are also at a high risk of respiratory complications and mortality during their stay in the NCC. However, invasive mechanical ventilation is also associated with ventilator induced lung injury(VILI). There is experimental evidence showing that VILI is influenced with every aspect of ventilator setting. Thus, we need to monitor a number of key parameters to ensure that mechanical ventilation do not lead to VILI such as low tidal volume, high positive end expiratory pressure (PEEP), limited plateau pressure and driving pressure. Mechanical power (MP) as calculated by combination of tidal volume, PEEP, plateau pressure, peak inspiratory pressure and respiratory rate is proposed to better capture the total energy delivered to lung parenchyma and risk of VILI. Therefore, it can be presumed that  MP may be better than any individual parameter in evaluating the prevalence of respiratory complications and mortality. However, there are only few investigations that have determined the connection between MP and outcome in neuro-critical patients.  This study is aimed to determine the predictive relevance of mechanical power in clinical outcomes of neuro-critical patients.

 
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