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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  
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 
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  
Status 
Not Applicable 
 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drshilpi1980@gmail.com].

  6. 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.

  7. 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.

 
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