| 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
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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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. |
|
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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
|
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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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