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CTRI Number  CTRI/2024/05/067981 [Registered on: 28/05/2024] Trial Registered Prospectively
Last Modified On: 23/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Changes in blood flow of brain after surgery 
Scientific Title of Study   Cerebrodynamic Changes Following Cranioplasty Using a Point-of-care Ultrasound: 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  Kiran Jangra 
Designation  Additional Professor 
Affiliation  Postgraduate Institute Of Medical Education And Research 
Address  Dept of Anaesthesia and Intensive Care
4th Floor Nehru Hospital
Chandigarh
CHANDIGARH
160012
India 
Phone  9914844330  
Fax    
Email  drkiransharma0117@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nivedita RK 
Designation  Senior Resident 
Affiliation  Postgraduate Institute Of Medical Education And Research 
Address  Dept of Anaesthesia and Intensive Care
4th Floor Nehru Hospital
Chandigarh
CHANDIGARH
160012
India 
Phone  7708355354  
Fax    
Email  rknivy26@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kiran Jangra 
Designation  Additional Professor 
Affiliation  Postgraduate Institute Of Medical Education And Research 
Address  Dept of Anaesthesia and Intensive Care
4th Floor Nehru Hospital
Chandigarh
CHANDIGARH
160012
India 
Phone  9914844330  
Fax    
Email  drkiransharma0117@gmail.com  
 
Source of Monetary or Material Support  
Postgraduate Institute of Medcal Education and Research, Sector 12, Chandigarh, India. PIN: 160012 
 
Primary Sponsor  
Name  Postgraduate Institute of Medical Education and Reseach 
Address  department of Anaesthesia, 4th floor, B Block, Nehru Hospital, Chandigarh, 160012 
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 
Kiran Jangra  PGIMER Chandigarh  Dept of Anaesthesia and Intensive Care 4th Floor Nehru Hospital PGIMER
Chandigarh
CHANDIGARH 
9914844330

drkiransharma0117@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G938||Other specified disorders 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  1. The patients with craniectomy defects
2. Posted for cranioplasty in the age group between
18-65 years will be enrolled in the study. 
 
ExclusionCriteria 
Details  Patient refusal
• Lumbar drain / CSF drainage before during study period
• Sepsis
12
• Known cardiac illness
• Poor window
• Known case of arteritis and major cerebral vasculature stenosis
• Patients with the history of ischemic stroke or transient ischemic attacks 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the changes in ICP of ipsilateral Middle cerebral artery using Pulsatility
index (PI) before and one hour post cranioplasty 
one-hour post cranioplasty. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the changes in anterior, middle, and posterior cerebral artery flow
velocities before and after cranioplasty. 
one-hour post cranioplasty. 
To compare the pulsatility index (PI) on both sides before and after cranioplasty.  one-hour post cranioplasty. 
To evaluate the neurological outcome post cranioplasty using Modified Rankin scale at
discharge and GOS-E at 3 months. 
3 months. 
To observe the changes in the preoperative symptoms after cranioplasty.  At discharge 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   10/06/2024 
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="0"
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 - NO
Brief Summary  

Decompressive craniectomy (DC) is the third most common neurosurgical procedure for treating TBI in India. Cranioplasty is one of the common neurosurgical procedures usually performed post decompressive craniectomy, to protect the underlying cerebral structures. The purpose of cranioplasty is not only to improve cosmesis but also to prevent neurological deterioration. Post-DC patients with large cranial defects are prone to develop the “syndrome of Trephined” also known as the “Sinking skin flap syndrome” which is manifested as dizziness, headache, seizures, motor deficits and language disturbances. The aim of this prospective, observational study is to compare the changes in ICP (derived

by Pulsatility Index of ipsilateral MCA) before and after cranioplasty using transcranial ultrasound.

TCCD examinations will be performed before induction using a phased array 1-5 MHz probe (GE LOGIQ machine) through the transtemporal window. The transducer probe will be placed over the temporal area just above the zygomatic arch in front of the tragus of the ear with the pointer facing medially. Before the examination, TCD will be performed under the same physiological conditions including the heart rate, blood pressure, temperature, and hematocrit pre- (before induction) and post-cranioplasty (1 hour after surgery). The Doppler spectrum of all the cerebral arteries will be obtained by 0 0-degree angle of insonation.

 
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