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CTRI Number  CTRI/2024/11/077482 [Registered on: 29/11/2024] Trial Registered Prospectively
Last Modified On: 27/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   An observational research to look at how impaired cerebral autoregulation is linked to neurological outcomes in people who have had traumatic brain injury with help of Transcranial Doppler 
Scientific Title of Study   Assessment of impaired cerebral autoregulation in patients with traumatic brain injury and its correlation with neurological outcomes: 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  Sutapa Ray Chaudhuri 
Designation  Junior Resident 
Affiliation  PGIMER, Chandigarh 
Address  Department Of Anaesthesia and Intensive Care, Level 4 Nehru Hospital, Block A, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9903094261  
Fax    
Email  yourfrndsutapa@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Hemant Bhagat 
Designation  Professor 
Affiliation  PGIMER, Chandigarh 
Address  Department Of Anaesthesia and Intensive Care, Level 4 Nehru Hospital, Block A, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9216387387  
Fax    
Email  hembhagat@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Hemant Bhagat 
Designation  Professor 
Affiliation  PGIMER, Chandigarh 
Address  Department Of Anaesthesia and Intensive Care, Level 4 Nehru Hospital, Block A, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9216387387  
Fax    
Email  hembhagat@rediffmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Medical Education and Research, Chandigarh Madhya Marg, Sector 12, Chandigarh pin 160012 
 
Primary Sponsor  
Name  PGIMER, Chandigarh 
Address  Madhya Marg, Sector 12, Chandigarh 160012 
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 
Sutapa Ray Chaudhuri  Post Graduate Institute of Medical Education and Research, Chandigarh  Department of Anaesthesia and Intensive Care, level 4, C block, Nehru Hospital
Chandigarh
CHANDIGARH 
9903094261

yourfrndsutapa@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Intramural)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G988||Other disorders of nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with moderate to severe isolated Traumatic Brain Injury

 
 
ExclusionCriteria 
Details  Patients with mild head injury, carotid artery disease, history of ischemic stroke, inadequate TCD window, pregnancy, cervical spine fracture
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Effect of impaired cerebral autoregulation (ICA) on neurological outcome in patients with moderate to severe TBI via modified Rankin Scale  12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Detect the incidence of impaired cerebral autoregulation (ICA) in TBI patients   At Admission to Neuro-Trauma ICU and at 48 hours 
Effect of ICA on duration of ICU stay  At discharge from ICU 
Correlation of ICA on neurological outcome with Modified Rankin Scale   At discharge from ICU 
Correlation of ICA on neurological outcome at discharge with Glassgow Coma Outcome Scale Extended   At 4 weeks 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/12/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
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  

Cerebral autoregulation (CA) is an integral autoregulatory mechanism of our body by which blood flow to the brain is maintained in spite of fluctuations in blood pressure. Autoregulation can be assessed by observing changes in cerebral blood flow or its equivalents in response to differences in cerebral perfusion pressure or mean arterial pressure. TBI is one of the largest medical burdens worldwide. TBI survivors suffer from several post injury sequalae months or years after the event. Research indicates that post Traumatic Brain Injury (TBI) cerebral autoregulatory mechanisms are lost and this can result in secondary brain injury. TBI has been known to increase the incidence of several neurological dysfunctions like stroke, seizure disorder and incidence of all-cause mortality. There is a lacuna in available literature regarding the assessment of impaired cerebral autoregulation (ICA) in patients of TBI using TCD along with Transient Hyperaemic Response Test (THRT) and its correlation with neurological outcome. We hypothesize that impaired cerebral autoregulation during initial 48 hours following TBI can compromise cerebral perfusion which can lead to poorer neurological outcome.

Cerebral autoregulation monitoring in TBI is essential for guiding clinical decision-making and treatment protocols. On receiving patients in the Trauma and Neuro Intensive Care Unit, patients will be stabilised as per ICU protocol. Thereafter, patients will be screened for eligibility which includes bilateral carotid ultrasound to rule out carotid plaque or atheroma to avoid the disruption and dislodgement of the plaque during THRR test. Once the patients fulfil the eligibility criteria they will be enrolled for the study. Baseline demographics shall be recorded. TCD will be done at baseline, during Transient Hyperaemic Response Test and after THRT. Dynamic autoregulation will be assessed via THR. Mean flow velocity, peak flow velocity, diastolic flow velocity and pulsatality index (PI) will be noted.  THR test will be repeated at 48 hours. The outcomes, as mentioned above shall be assessed.

 

 

 
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