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CTRI Number  CTRI/2022/02/040675 [Registered on: 28/02/2022] Trial Registered Prospectively
Last Modified On: 26/02/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Transcranial Doppler used to non invasively identify whether ability of brain to compensate for pressure changes improves after surgery in patients with different levels of sensorium prior to surgery and to find to if this can be useful to predict the prognosis of the patients . 
Scientific Title of Study   Evaluation of Transcranial Doppler Spectral(TCD) signatures and assessment of cerebral oxygenation using Near infrared spectroscopy (NIRS) in patients undergoing neurosurgical procedures as a novel marker for clinical outcome and prognostication -An observational study. 
Trial Acronym  SCTTCD 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  JEEVA GEORGE 
Designation  SENIOR RESIDENT 
Affiliation  SCTIMST 
Address  DIVISION OF NEUROANAETHESIA,SCTIMST,TRIVANDRUM
Upasana,poomattam,puthupally,Kottayam,kerala
Thiruvananthapuram
KERALA
695011
India 
Phone  9779886524  
Fax    
Email  jeevaupasana@gmai.com  
 
Details of Contact Person
Scientific Query  
Name  DR MANIKANDAN S  
Designation  PROFESSOR AND HOD  
Affiliation  SREE CHITRA TIRUNAL INSTITUTE FOR MEDICAL SCIENCES  
Address  DIVISION OF NEUROANAETHESIA, SREE CHITRA TIRUNAL INSTITUTE FOR MEDICAL SCIENCE AND TECHNOLOGY, TRIVANDRUM
DEPARTMENT OF ANAESTHESIA, SREE CHITRA TIRUNAL INSTITUTE FOR MEDICAL SCIENCE AND TECHNOLOGYT, TRIVANDRUM
Thiruvananthapuram
KERALA
695011
India 
Phone  9446334711  
Fax    
Email  kanmanis@sctimst.ac.in  
 
Details of Contact Person
Public Query  
Name  DR MANIKANDAN S 
Designation  PROFFESOR AND HOD  
Affiliation  SCTIMST 
Address  DIVISION OF NEUROANAETHESIA,SCTIMST,TRIVANDRUM
DEPARTMENT OF ANAESTHESIA ,SCTIMST,TRIVANDRUM
Thiruvananthapuram
KERALA
695011
India 
Phone  9779886524  
Fax    
Email  kanmanis@sctimst.ac.in  
 
Source of Monetary or Material Support  
SCTIMST 
 
Primary Sponsor  
Name  DIRECTOR  
Address  SCTIMST,TRIVANDRUM 
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 
DR MANIKANDAN  SCTIMST  DIVISION OF NEUROANAESTHESIA ,SCTIMST
Thiruvananthapuram
KERALA 		 9446334711

kanmanis@sctimst.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C718||Malignant neoplasm of overlappingsites of brain,  
 
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 posted for supratentorial craniotomy for brain tumour resection with tumour size more than 6 cm along with features of raised ICP, without hydrocephalus.
• Patients undergoing decompressive craniectomy for malignant stroke.
• Patients with aneurysmal SAH undergoing clipping.
• Age more than 18 years
 
 
ExclusionCriteria 
Details  • Refusal of consent for study.
• Age < 18 years, > 65 years
• Pregnant and lactating mothers
• patients with technical problems wherein TCD cannot be performed optimally such as thick skull leading to a poor window for insonation of the vessel.
• Patients with severe comorbidity like decompensated heart failure, coronary heart disease, Irregularity in the left ventricular ejection volume (due to, for example, fibrillation or atrial flutter, or frequent ventricular extrasystole); and cardiac frequencygreater than 140 beats/minute, advanced liver or renal disease, uncontrolled hypertension, diabetes mellitus, severe pulmonary disease.
Recurrent surgery.
Patients who are on hemodynamic support before surgery.
Patients with Aortic Regurgitation 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary objective is to assess the impact of different spectral TCD waveform in different preoperative GCS scores of patients and to correlate these spectral changes with the outcome of patients at the time of hospital discharge.  Primary objective is to assess the impact of different spectral TCD waveform in different preoperative GCS scores of patients and to correlate these spectral changes with the outcome of patients at the time of hospital discharge. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To correlate the different spectral TCD waveform as a marker of cerebral blood flow with NIRS values which is an indicator of cerebral oxygenation.
2. To correlate different spectral TCD, MCA peak and mean flow velocity with preoperative GCS scores and to compare changes in TCD spectral pattern, MCA flowvelocity, pupillary size, GCS, NIRS values between preoperative and postoperative values at 24 and 48 hours and at hospital discharge.
 		 at the time of hospital discharge 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/03/2022 
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="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

To correlate different spectral TCD, MCA peak and mean flow velocity with preoperative GCS scores and to compare changes in TCD velocity pattern, MCA flow velocity, pupillary size, GCS, NIRS values between preoperative and postoperative values at 24 and 48 hours and at hospital discharge.

 
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