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CTRI Number  CTRI/2026/02/104549 [Registered on: 23/02/2026] Trial Registered Prospectively
Last Modified On: 17/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Effect of Body Position on Breathing in Adults Undergoing Brain Surgery Using a Non-Invasive Lung Monitoring Method. 
Scientific Title of Study   Regional ventilation distribution in adult patients undergoing neurosurgical procedures in different positions - a prospective interventional study using electrical impedance tomography. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Soumi Sunabh Parulkar 
Designation  Senior Resident - Post Doctoral Fellowship in Neuroanaesthesia 
Affiliation  National Institute of Mental Health And Neuro Sciences 
Address  Department of Neuroanaesthesia & Neurocritical Care, 3rd Floor, Faculty Building, National Institute of Mental Health And Neuro Sciences,P.B.NO.2900, Hosur Road, Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  9158966677  
Fax    
Email  soumiparulkar2712@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Bharath S 
Designation  Additional Professor 
Affiliation  National Institute of Mental Health And Neuro Sciences,P.B.NO.2900, Hosur Road, Bengaluru 
Address  Department of Neuroanaesthesia and Neurocritical Care, 3rd Floor, Faculty building, National Institute of Mental Health And Neuro Sciences,P.B.NO.2900, Hosur Road, Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  9945965202  
Fax    
Email  bharathvinay@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Bharath S 
Designation  Additional Professor 
Affiliation  National Institute of Mental Health And Neuro Sciences,P.B.NO.2900, Hosur Road, Bengaluru 
Address  Department of Neuroanaesthesia and Neurocritical Care, 3rd Floor, Faculty building, National Institute of Mental Health And Neuro Sciences,P.B.NO.2900, Hosur Road, Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  9945965202  
Fax    
Email  bharathvinay@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Mental Health And Neuro Sciences,P.B.NO.2900, Hosur Road, Bengaluru, Karnataka, India, Pin code - 560029 
 
Primary Sponsor  
Name  National Institute of Mental Health And Neuro Sciences 
Address  National Institute of Mental Health And Neuro Sciences,P.B.NO.2900, Hosur Road, Bengaluru 560029 
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 Soumi Sunabh Parulkar  National Institute of Mental Health And Neuro Sciences  Department of Neuroanaesthesia and Neurocritical Care, 3rd Floor, Faculty building, National Institute of Mental Health And Neuro Sciences, Hosur Road, Bengaluru 560029
Bangalore
KARNATAKA 
9158966677

soumiparulkar2712@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  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 
Intervention  Pressure controlled ventilation   Zero and Five PEEP will be applied each for 5 minutes. 
Comparator Agent  Volume controlled ventilation mode  Zero and Five PEEP will be applied for 5 minutes each. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  PATIENTS UNDERGOING ELECTIVE NEUROSURGERY UNDER GENERAL ANAESTHESIA 
 
ExclusionCriteria 
Details  1. Refusal of consent
2. Patients with an endotracheal tube in situ prior to the planned surgical procedure
3. Pregnancy
4. Patients with cardiac failure, cardiac pacemakers, etc.
5. Obese patients (BMI more than 30)
6. At risk of aspiration – poor GCS, bulbar palsy
7. Patients with known respiratory disease – pleural effusion, pneumothorax, COPD, Asthma, pneumonia, emphysematous bulla.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• To determine the changes in EIT parameters - global inhomogeneity index (GII), Anterior/Posterior ratio (A/P ratio), and Respiratory ventilation delay (RVD) in adult neurosurgical patients undergoing surgery in supine, lateral and prone positions.
• To compare the EIT parameters - global inhomogeneity index (GII), Anterior/Posterior ratio (A/P ratio), and Respiratory ventilation delay (RVD) changes with volume and pressure-controlled ventilation.
 
At basline, after induction, after positioning, every 5 minutes for 1 hour. 
 
Secondary Outcome  
Outcome  TimePoints 
• To compare the EIT parameters - global inhomogeneity index (GII), Anterior/Posterior ratio (A/P ratio), and Respiratory ventilation delay (RVD) changes with PEEP zero and 5 cmH2O in both ventilation modes.
• To correlate the EIT paramters - global inhomogeneity index (GII), Anterior/Posterior ratio (A/P ratio), and Respiratory ventilation delay (RVD) changes with changes in driving pressure and lung compliance.
 
- At baseline before induction
- After Intubation in supine flat position – 5 Min
- In final position (5 min recording each)
o VCV0 – Volume controlled ventilation at PEEP of 0 cmH2O
o VCV5 – Volume controlled ventilation at PEEP of 5 cmH2O
o PCV0 – Pressure controlled ventilation at PEEP of 0 cmH2O
o PCV5 – Pressure controlled ventilation at PEEP of 5 cmH2O
 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   28/02/2026 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
Protecting the lungs during surgery is important because mechanical ventilation can sometimes cause lung injury, Newer approaches focus on adjusting ventilation to suit individual patients. Electrical impedance tomography is a safe, noninvasive method that allows real time monitoring of how air is distributed in different parts of the lungs without radiation.
Neurosurgical patients are especially vulnerable to changes in lung function during surgery due to long operating times, mechanical ventilation, fluid shifts and interactions between the brain and lungs. Neurosurgical procedures require patients to be placed in different positions such as supine, lateral or prone, which can significantly affect breathing and oxygen levels.
Previous studies show that body position influences how evenly air is distributed in the lungs. Prone positioning often improves ventilation in the posterior parts of the lungs and reduces lung collapse, but it may overstretch other lung areas. The effects of lateral positioning vary between patients. There is limited information on these position related changes specifically in neurosurgical patients.
There is also uncertainty about the best ventilation mode and pressure settings during neurosurgery. While moderate positive end pressure can improve lung expansion and reduce collapse, higher pressures may affect brain blood flow and pressure inside the skull. Studies using electrical impedance tomography suggest that moderate pressure improves ventilation distribution, but optimal settings differ between patients and positions.
This study aims to monitor and compare changes in lung ventilation in adult neurosurgical patients operated in different body positions using electrical impedance tomography. The findings may help guide personalised ventilation strategies and reduce the risk of lung injury during surgery.



 
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