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CTRI Number  CTRI/2025/07/091714 [Registered on: 25/07/2025] Trial Registered Prospectively
Last Modified On: 25/07/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Impact of Prone Positioning on Respiratory Mechanics in Anaesthetized Patients with and without Bolsters 
Scientific Title of Study   The effect of prone position on the respiratory mechanics, with and without bolsters in patients under general anaesthesia : A cross sectional 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  Dr Mahesh Chandra 
Designation  Associate Professor 
Affiliation  Rajarajeswari Medical College And Hospital Bangalore 
Address  No 202, 2nd Floor, Department of Anaesthesiology, RajaRajeswari Medical College and Hospital, Kambipura, Mysore Road, Bangalore - 560074, Karnataka, India.

Bangalore
KARNATAKA
560074
India 
Phone  9483251081  
Fax    
Email  Mahesh324@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr G K ANKUSH 
Designation  Post Graduate 
Affiliation  Rajarajeswari Medical College And Hospital Bangalore 
Address  No 202, 2nd Floor, Department of Anaesthesiology, RajaRajeswari Medical College and Hospital, Kambipura, Mysore Road, Bangalore - 560074, Karnataka, India.

Bangalore
KARNATAKA
560074
India 
Phone  7338120305  
Fax    
Email  28121998gkankush@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr G K ANKUSH 
Designation  Post Graduate 
Affiliation  Rajarajeswari Medical College And Hospital Bangalore 
Address  No 202, 2nd Floor, Department of Anaesthesiology, RajaRajeswari Medical College and Hospital, Kambipura, Mysore Road, Bangalore - 560074, Karnataka, India.

Bangalore
KARNATAKA
560074
India 
Phone  7338120305  
Fax    
Email  28121998gkankush@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Rajarajeswari Medical College And Hospital , Bangalore 
Address  No 202, 2nd Floor, Department of Anaesthesiology, RajaRajeswari Medical College and Hospital, Kambipura, Mysore Road, Bangalore - 560074, Karnataka, India. 
Type of Sponsor  Private medical college 
 
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 Mahesh Chandra  RajaRajeswari Medical College And Hospital , Bangalore  Department of Anaesthesiology,2nd Floor, RajaRajeswari Medical College and Hospital, Kambipura, Mysore Road, Bangalore - 560074, Karnataka, India.
Bangalore
KARNATAKA 
9483251081

Mahesh324@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RRMCH Institutional Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M519||Unspecified thoracic, thoracolumbar and lumbosacral intervertebral disc disorder, (2) ICD-10 Condition: N200||Calculus of kidney,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patients of age group 20 to 60 years, undergoing elective surgeries under general anaesthesia in the prone position.
2) Patients classified under American Society of Anaesthesiologists (ASA) 1 and 2 after thorough Pre-Anaesthetic evaluation.
 
 
ExclusionCriteria 
Details  1)Patient refusal.
2)Pregnant women.
3)Patients with BMI of 30kg/m2 and more.
4)Patients undergoing emergency surgeries.
5)Patients with significant spinal deformities, scoliosis, lardosis, kyphosis, ankylosing spondylitis.
6)Post intubation Bronchospasm.
7)Patients with compromised Respiratory conditions.
8)Patients with Oropharyngeal or Facial Pathologies
9)Patients who are active smokers. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Dynamic compliance of the respiratory system  5 minutes after intubation, Prone, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, After making supine 
 
Secondary Outcome  
Outcome  TimePoints 
Peak airway pressure (P peak), mean airway pressure (P mean), end tidal CO2(EtCO2), heart rate (HR), mean arterial pressure (MAP) and oxygen saturation (SpO2)   5 minutes after intubation, Prone, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, After making supine 
 
Target Sample Size   Total Sample Size="106"
Sample Size from India="106" 
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)   08/08/2025 
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  

When a patient is positioned in the prone posture under general anaesthesia, abdominal pressure exerts force on the internal organs, causing the diaphragm to shift towards the cephalad direction. Additionally, the weight of the trunk compresses the thoracic cavity, reducing the anterior-posterior  chest diameter. These alterations in body mechanics lead to a 20-30 percent reduction in respiratory compliance and an increase in peak inspiratory pressure. Consequently, the observed rise in PIP during prone positioning is primarily attributed to the diminished respiratory compliance resulting from these mechanical factors.

In conditions of reduced pulmonary compliance, achieving adequate ventilation may necessitate the use of elevated airway pressures. These elevated pressures can compromise venous return to the heart, leading to a reduction in cardiac output and an elevation in systemic venous pressure. Increased venous pressure in the epidural venous plexus is a recognized contributor to excessive surgical bleeding. Furthermore, elevated spinal venous pressure can decrease spinal cord perfusion pressure, calculated as the difference between mean arterial pressure and spinal venous pressure, thereby increasing the risk of neurological complications.

To mitigate these variations, a bolster is traditionally placed beneath the chest and pelvis to reduce intra-abdominal pressure and its associated physiological alterations. Spine surgeons commonly employ these bolsters to achieve optimal patient positioning during spinal surgeries. However, in percutaneous nephrolithotomy procedures, urologists typically avoid the use of such supports, as they can obstruct surgical access to the targeted area

Thus, this study will compare the changes in Dynamic compliance of the respiratory system in the prone position with and without bolsters. In addition, changes in Peak airway pressure, mean airway pressure, EtCO2, heart rate, mean arterial pressure and Oxygen saturation will also be studied.

 
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