| CTRI Number |
CTRI/2025/02/081341 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate the effect of removing the skull bone on brain oxygenation in head injury patients. |
|
Scientific Title of Study
|
To evaluate the effect of decompressive craniectomy on cerebral venous oxygen saturation (SjVO2) in traumatic brain injury patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Karma Ongmu Bhutia |
| Designation |
D.M. Senior Resident Neuroanaesthesiology and Critical Care |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Neuroanaesthesiology and Critical Care
6th Floor
Neurosciences Centre
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9894354443 |
| Fax |
|
| Email |
KarmaOngmu1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navdeep Sokhal |
| Designation |
Professor Neuroanaesthesiology and Critical Care |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Neuroanaesthesiology and Critical Care
6th Floor
Neurosciences Centre
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9953279619 |
| Fax |
|
| Email |
drnavdeepsokhal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Navdeep Sokhal |
| Designation |
Professor Neuroanaesthesiology and Critical Care |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Neuroanaesthesiology and Critical Care
6th Floor
Neurosciences Centre
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9953279619 |
| Fax |
|
| Email |
drnavdeepsokhal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS, New Delhi |
| Address |
Department of Neuroanaesthesiology and Critical Care
6th Floor
Neurosciences Centre
AIIMS New Delhi |
| 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 |
| Dr Karma Ongmu Bhutia |
AIIMS , New Delhi |
Department of Neuroanaesthesiology and Criitical Care, New Delhi
South
DELHI |
9894354443
KarmaOngmu1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S062||Diffuse traumatic brain injury, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18-65 yrs
2.Either sex
3.ASA Physical status I/II/III
4.Patient admitted within 48hrs of TBI
5.Moderate to severe TBI (GCS ≤ 12 after resuscitation)Â
6.Patients undergoing invasive ICP monitoring with a sustained rise in ICP refractory to medical management.
|
|
| ExclusionCriteria |
| Details |
1.ASA physical status IV/ V
2.Any brain mass lesion requiring immediate 3.decompression
4.Patients with dilated unreactive pupils
5.Non-traumatic intracranial mass lesion
6.Past H/o any intracranial surgery
7.Coagulation abnormality
8.Unstable cervical spine injury
9.Pregnant and lactating patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare jugular venous oximetry values before and after decompressive craniectomy (DC) |
multiple readings will be taken at multiple timepoints starting before DC to 24 hours after DC. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To correlate the lowest values of SjVO2 with the outcome (GOSE) at discharge and at 3 months
To correlate changes in values of SjVO2 with outcome (GOSE) at discharge and at 3 months
To correlate values of SjVO2 and ICP (pre- and post-decompressive craniectomy)
To correlate changes in AVDO2, AVDG and VADL values with the outcome (Pre-operative, Intra-operative just after the dural opening, and post-operative at 1, 6 & 24 h)
|
Multiple readings will be taken at multiple timepoints starting before DC to 24hrs after DC |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
10/03/2025 |
| 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="6"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Traumatic brain injury (TBI) is one of the leading causes of morbidity and mortality worldwide. After the primary insult, secondary insult plays a major role in the pathophysiology of TBI. Factors leading to secondary insult include, hypotension, hypoxia, hypercarbia, decreased cerebral blood flow (CBF), decreased cerebral perfusion pressure (CPP), increased intracranial pressure (ICP), etc. Many protocols are followed by neuro-intensivists to minimize secondary insult and to maintain adequate CBF by decreasing ICP to <22 mm Hg and maintaining an optimum CPP between 60 to 70 mm Hg for adults (as per Brain Trauma Foundation (BTF) guidelines 2016). Increased ICP is a common occurrence after TBI and decompressive craniectomy is required to reduce ICP and improve CPP if medical measures fail. However, CPP may not always improve despite a decrease in ICP in TBI patients and thus may lead to cerebral ischemia and infarction. The DECRA (Decompressive Craniectomy in Diffuse Traumatic Brain Injury) trial, in patients with severe TBI and refractory intracranial hypertension, showed that an early bifronto-temporo-parietal decompressive craniectomy led to a decrease in ICP and length of ICU stay but did not result into a better outcome. Cerebral ischemia and cerebral oxygenation are important factors for clinical outcome in TBI patients. Cerebral jugular venous oximetry (SjVO2) is a marker of global cerebral blood flow and brain metabolism that indicates the delivery and utilization of oxygen by brain cells. Along with SjVO2, cerebral arteriovenous oxygen difference (AVDO2), arterial-venous differences of glucose (AVDG), and venous-arterial difference of lactate (VADL) have also been used as surrogate markers of cerebral perfusion and metabolism. Decompressive craniectomy has an established role in decreasing ICP but has never been evaluated for its effect on jugular venous oximetry. Thus, there is no concrete evidence to state whether the decrease in ICP after decompressive craniectomy leads to improvement in cerebral blood flow and/or cerebral oxygenation which may result in improved clinical outcome. Considering these factors, this study is planned to determine whether decompressive craniectomy offers any advantage in terms of improved CBF and improved oxygen delivery to brain in moderate to severe TBI patients |