| CTRI Number |
CTRI/2018/05/014022 [Registered on: 21/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
15/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To find out the effect improving ICU monitoring and care on recovery of head injury patients |
|
Scientific Title of Study
|
EVALUATION OF OUTCOME IN SEVERE HEAD INJURY PATIENTS AFTER CEREBRAL HEMODYNAMIC MONITORING BY TRANS CRANIAL DOPPLER AND SJVO2 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neerja Bharti |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Department of Anaesthesia and Intensive Care, PGIMER
Department of Anaesthesia and Intensive Care, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9915575145 |
| Fax |
|
| Email |
bhartineerja@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neerja Bharti |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Department of Anaesthesia and Intensive Care, PGIMER
Department of Anaesthesia and Intensive Care, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9915575145 |
| Fax |
|
| Email |
bhartineerja@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Rayan Rohith |
| Designation |
Resident |
| Affiliation |
PGIMER |
| Address |
Department of Anaesthesia and Intensive Care, PGIMER
Department of Anaesthesia and Intensive Care, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8195928777 |
| Fax |
|
| Email |
rayanrohith@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia and Intensive care, PGIMER, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Medical Education and Research |
| Address |
Sector-12, Chadigarh |
| Type of Sponsor |
Research institution |
|
|
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 |
| Neerja Bharti |
Post Graduate Institute of Medical Education and Research |
Department of
anesthesia and
intensive care,level
4,Nehru hospital,PGIM
ER,sector-12,chandigar
h-160012
Chandigarh
CHANDIGARH
Chandigarh
CHANDIGARH |
9915575145
bhartineerja@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA GRADE 1 to 3 , |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients having severe head injury |
|
| ExclusionCriteria |
| Details |
Patients with multiple trauma,Patients with multi-organ failure,Patients who have severe haemodynamic instability and Patients with sepsis or coagulopathy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine CPP by TCD and cerebral oxygen extraction by SjVO2 and correlate these values with outcome in severe TBI patients. |
At 3 months after head injury |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate cerebral haemodynamic values obtained by TCD with ICP value measured by ultrasound guided ONSD. |
Daily for 7 days after ICU admission |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/10/2014 |
| Date of Study Completion (India) |
24/12/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="18" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this prospective observational study 30 patients of severe head injury were monitored in ICU with advanced cerebral noninvasive monitoring of intracranial pressure (ICP) and cerebral perfusion pressure (CPP) with TCD. We found that 21/30 patients had good outcome while 9/30 patients had bad outcome at 3 months. Patients having raised ICP and abnormal CPP had poor outcome. The noninvasive cerebral haemodynamic monitoring helped in prediction of outcome of these patients. |