| 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
|
|
|
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
|
|
|
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
|
|
|
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. |