| 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
|
|
|
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
|
|
|
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. |