| CTRI Number |
CTRI/2024/08/071773 [Registered on: 01/08/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Continuous Assessment of Cerebral oxygen Saturation using an Instrument such as Near Infrared Spectroscopy (NIRS) and Transcranial Doppler (TCD) in Subarachnoid Haemorrhage patients after Neuroendovascular coiling. |
|
Scientific Title of Study
|
Continuous assessment of Cerebral oxygenation using Near Infrared Spectroscopy (NIRS) and Transcranial Doppler (TCD) in patients of subarachnoid haemorrhage after Neuroendovascular coiling: 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 |
Dr Shilpi Misra |
| Designation |
Associate Professor |
| Affiliation |
Dr. Ram Manohar Lohia Institute of Medical Sciences |
| Address |
Department of Anesthesiology and Critical Care Medicine, Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomtinagar, Lucknow
Lucknow UTTAR PRADESH 226010 India |
| Phone |
9839932239 |
| Fax |
|
| Email |
drshilpi1980@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shilpi Misra |
| Designation |
Associate Professor |
| Affiliation |
Dr. Ram Manohar Lohia Institute of Medical Sciences |
| Address |
Department of Anesthesiology and Critical Care Medicine, Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomtinagar, Lucknow
Lucknow UTTAR PRADESH 226010 India |
| Phone |
9839932239 |
| Fax |
|
| Email |
drshilpi1980@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mamtha Shri Natarajan |
| Designation |
Junior Resident |
| Affiliation |
Dr. Ram Manohar Lohia Institute of Medical Sciences |
| Address |
Department of Anesthesiology and Critical Care Medicine, Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomtinagar, Lucknow
Lucknow UTTAR PRADESH 226010 India |
| Phone |
8344434332 |
| Fax |
|
| Email |
mamthashrimbbs2014@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomtinagar, Lucknow, Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr. Ram Manohar Lohia Institute of Medical Sciences |
| Address |
Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, gomtinagar, Lucknow, Uttar Pradesh, 226010 |
| 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 |
| Dr Shilpi Misra |
Dr. Ram Manohar Lohia Institute of Medical Sciences |
OT 1,2 of Department of Neurosurgery, 2nd floor, Dr. RMLIMS
Lucknow Lucknow UTTAR PRADESH |
9839932239
drshilpi1980@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G978||Other intraoperative and postprocedural complications and disorders of nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Modified Hunt & Hess scale grade 1 and 2
Patient with ACOM Aneurysm |
|
| ExclusionCriteria |
| Details |
Obese Patients
Patients having Neurological trauma
Patients having space occupying lesion
Patients having any history of psychiatric illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Correlate Cerebral Oxygenation Saturation depicted by [NIRS] Near infrared spectroscopy with Transcranial Doppler[TCD] in subarachnoid haemorrhage patient undergoing coiling |
To Correlate Cerebral Oxygenation Saturation depicted by [NIRS] Near infrared spectroscopy with Transcranial Doppler[TCD] in subarachnoid haemorrhage patient undergoing coiling every 6 hours for 72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To correlate cerebral oxygenation saturation depicted by Near Infrared Spectroscopy (NIRS) with clinicoradiological findings such as
Glasgow Coma scale
Modified Hunt and Hess scale
CT Imaging [Fisher Grading] |
every 6 hours for 72 hours |
|
|
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)
|
03/10/2024 |
| 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="6" 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drshilpi1980@gmail.com].
- For how long will this data be available start date provided 03-10-2024 and end date provided 03-10-2048?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Aneurysmal subarachnoid hemorrhage
is a neurological emergency with high morbidity and fatality rates. The overall
prognosis depends on the volume of initial bleed, rebleeding and degree of
cerebral ischemia. Coiling is a minimally invasive procedure which seals the
aneurysm and prevents further bleeding. In patients of Subarachnoid hemorrhage, the assessment of cerebral autoregulation aids in the prognosis as
well as detection of vasospasm. Early post operative management of patients undergoing coiling includes maintaining hemodynamic stability, early detection
of cerebral hypoperfusion and management
of cardiopulmonary complications which
has influence on reducing cerebral vasospasm and thus cerebral ischemia. Monitoring of cerebral blood flow and cerebral oxygenation is a vital
component in multimodal intensive care in patients of Subarachnoid
Hemorrhage. Clinico radiological parameters,
Modified Hunt and Hess grading and Fisher grading have been used to grade Subarachnoid
Hemorrhage severity. Different Modalities have been used for bedside monitoring of cerebral perfusion. The importance of Transcranial Doppler
(TCD) in acute phase of a Subarachnoid Hemorrhage and its clinical impact on
occurrence of vasospasm and outcome has
been studied previously. But its use has the disadvantage of being
investigator dependent and impractical for long duration monitoring in
postoperative period. Continuous measurement of cerebral
oxygenation with Near Infrared Spectroscopy has come as a promising tool and has
been widely studied in numerous cardiac and surgical procedures. NIRS enables
continuous and noninvasive measurement of regional cerebral oxygenation
saturation via absorption of near infrared light that can provide a surrogate
marker of change in cerebral blood flow in the form of Tissue oxygenation Index. In contrast to TCD, NIRS sensors are
very easy to apply [since the probes attach to forehead with self adhesive
pads] hence suitable for long term monitoring. Use of NIRS in postoperative Neuroendovascular procedures (coiling) for continuous measurement of cerebral oxygenation for early
detection of hypoperfusion is yet to be
explored. The aim of our study is to assess
whether NIRS can be used for continuous measurement of cerebral oxygenation in
postoperative period in Subarachnoid Hemorrhage patients undergoing Coiling and
to correlate it with the clinicoradiological findings.
|