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CTRI Number  CTRI/2024/05/067808 [Registered on: 22/05/2024] Trial Registered Prospectively
Last Modified On: 10/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   To correlate the pressure inside the skull using direct measurement vs ultrasound in patients with high intracranial pressures. 
Scientific Title of Study   Correlation between Invasive and Non-Invasive techniques of ICP measurements in patients with Hydrocephalus: 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  Vaibhav Pandey 
Designation  Senior Resident  
Affiliation  PGIMER, Chandigarh 
Address  Division of Neuroanaesthesia, 4th floor, Department of Anesthesia and Intensive Care, Nehru Hospital, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9140253559  
Fax    
Email  drvaibhavpandey@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Ankur Luthra 
Designation  Associate Professor 
Affiliation  PGIMER, Chandigarh 
Address  Division of Neuroanaesthesia, 5th floor, Faculty offices, Department of Anesthesia and Intensive Care, Nehru Hospital, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9868057732  
Fax    
Email  zazzydude979@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vaibhav Pandey 
Designation  Senior Resident  
Affiliation  PGIMER, Chandigarh 
Address  Division of Neuroanaesthesia, 4th floor, Department of Anesthesia and Intensive Care, Nehru Hospital, PGIMER, Chandigarh


CHANDIGARH
160012
India 
Phone  9140253559  
Fax    
Email  drvaibhavpandey@hotmail.com  
 
Source of Monetary or Material Support  
Postgraduate Institute of Medical Education and Research, Sector 12 Chandigarh, India - 160012 
 
Primary Sponsor  
Name  Dr Ankur Luthra 
Address  Division of Neuroanaesthesia, 4th floor, Block -A, Nehru Hospital, PGIMER, Chandigarh, India - 160012 
Type of Sponsor  Other [Chief Guide] 
 
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 Vaibhav Pandey  Postgraduate Institute of Medical Education and Research  Department of Anaesthesia and Intensive Care, 5th floor, A-Block, Nehru Hospital, PGIMER, Chandigarh
Chandigarh
CHANDIGARH 		 9140253559

drvaibhavpandey@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Intramural), Postgraduate Institute of medical Education and Research, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G911||Obstructive hydrocephalus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients with proven hydrocephalus on CT Scan undergoing VP Shunt surgery 
 
ExclusionCriteria 
Details  Refusal to consent, orbital tumours, iridodialysis, glaucoma and orbital trauma 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To establish a correlation between combined values of PI, ONSD, NPi with Invasive ICP (Ventricular opening pressure) in hydrocephalus patients undergoing VP Shunt surgeries.  At 8 weeks post recruitment of all patients 
 
Secondary Outcome  
Outcome  TimePoints 
1. To establish the correlation between the following clusters – PI & ONSD vs Opening pressure, ONSD, NPi vs Opening pressure & NPi & PI vs Opening pressure.  At 8 weeks post recruitment of all the patients 
2. To define optimal ONSD, PI & NPi cutoff values for the prediction of intracranial Hypertension  At 8 weeks post recruitment of all the patients 
3. To compare the predictive values of these non-invasive techniques in isolation.  At 8 weeks, post recruitment of all the patients. 
4. To develop a regression equation between ICP, ONSD, PI & Npi for age specific groups to calculate ICP with non-invasive modalities.  At 8 weeks post recruitment of all the patients 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/06/2024 
Date of Study Completion (India) 25/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 25/05/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

  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 - For individual participant data meta-analysis.

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

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Hydrocephalus is an active distension of the ventricular system of the brain related to the inadequate passage of CSF from its point of production within the ventricular system to its point of absorption into the systemic circulation. ICP can be defined as the pressure inside the cranial vault and is the pressure exerted by fluids such as cerebrospinal fluid (CSF) inside the skull and on the brain tissue. ICP is measured in millimetres of mercury (mmHg) and at rest, is normally 7–15 mmHg for a supine adult. The gold standard method of ICP measurement is the Intraventricular catheter based system, but its use has been limited because of complications, cost limiting factors and the requirement of trained personnel to insert the catheter. Thus, non-invasive methods of ICP measurements come into focus which includes Optic Nerve Sheath Diameter measurement using an USG, various methods to estimate PI using TCD/TCCD and the calculation of Npi using a pupilometer. Individually these modalities have their fallacies and the correlation of their combined estimations have not been reliably assessed so far. In our designed study, we will be focusing on mainly ONSD, (PI)Pulsatility index measured by TCD and NPi- Neurological Pupillary index (measured by pupillometer) and their correlations among themselves and with ventricular opening pressure (Invasive intraventricular ICP measurement). We hypothesize that the Combined measurement of PI, ONSD and Npi will have the best correlation with Invasive ICP (Ventricular opening pressure), and it can be used to estimate ICP in hydrocephalus patients with reliable accuracy.

 
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