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CTRI Number  CTRI/2024/11/076960 [Registered on: 18/11/2024] Trial Registered Prospectively
Last Modified On: 01/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study comparing changes in hemodynamics and respiratory parameters in different modes of ventilation in patients undergoing spine surgeries in prone position. 
Scientific Title of Study   The comparative study of effects of volume controlled ventilation (VCV) and pressure controlled ventilation (PCV) on hemodynamics and respiratory mechanics in patients undergoing spine surgeries in prone position-prospective randomised controlled 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  DrAshwini H 
Designation  Professor MD.Anaesthesiology 
Affiliation  Rajarajeswari medical college and hospital 
Address  Rajarajeswari medical college and hospital kengeri satellite town kambipura

Bangalore
KARNATAKA
560074
India 
Phone  8971265579  
Fax    
Email  drashwinih29@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrAshwini H 
Designation  Professor MD.Anaesthesiology 
Affiliation  Rajarajeswari medical college and hospital 
Address  Rajarajeswari medical college and hospital kengeri satellite town kambipura

Bangalore
KARNATAKA
560074
India 
Phone  8971265579  
Fax    
Email  drashwinih29@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrAshwini H 
Designation  Professor MD.Anaesthesiology 
Affiliation  Rajarajeswari medical college and hospital 
Address  Rajarajeswari medical college and hospital kengeri satellite town kambipura

Bangalore
KARNATAKA
560074
India 
Phone  8971265579  
Fax    
Email  drashwinih29@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesiology, 2nd floor , rajarajeswari medical college and hospital , bangalore-560074 
 
Primary Sponsor  
Name  Jasni KB 
Address  Rajarajeswari medical college and hospital, mysore road, kambipura, bangalore, karnataka-560074 
Type of Sponsor  Other [Self] 
 
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 
DrJasni KB  Rajarajeswari medical college and hospital  Department of Anaesthesiology, Rajarajeswari medical college and hospital , mysore road, kambipura, bangalore, karnataka - 560074
Bangalore
KARNATAKA 
9538808087

jasnibasheer97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  PRESSURE CONTROLLED VENTILATION (PCV)  All patients will be ventilated with Anesthesia workstation (Drager Atlan A350)P peak in PCV will be adjusted to deliver Vt of 8 ml/kg ideal body weight and Respiratory Rate [RR] will be adjusted to keep end tidal carbon oxide (EtCO2) between 33–36 mm Hg. It will have standardised ventilatory settings with Fractional inspired oxygen concentration (FiO2) of 0.4, Positive End Expiratory Pressure (PEEP) of 5 cm H2O and Inspiratory: Expiratory time (I:E) of 1:2 ratio. Duration as per surgical requirements 
Comparator Agent  VOLUME CONTROL VENTILATION (VCV)  All patients will be ventilated with Anesthesia workstation ,tidal volume (Vt) in VCV will be adjusted to deliver Vt of 8 ml/kg ideal body weight and Respiratory Rate [RR] will be adjusted to keep end tidal carbon oxide (EtCO2) between 33–36 mm Hg. It will have standardised ventilatory settings with Fractional inspired oxygen concentration (FiO2) of 0.4, Positive End Expiratory Pressure (PEEP) of 5 cm H2O and Inspiratory: Expiratory time (I:E) of 1:2 ratio. Duration as per surgical requirements 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA-1 and ASA-2 patients aged 20-60 years scheduled for elective spine surgeries in prone position under general anaesthesia will be enrolled for the study. 
 
ExclusionCriteria 
Details  Body mass index (BMI) >30
Documented autonomic neuropathy
Obstructive or restrictive lung diseases
Repeat spine surgeries
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effect of PCV with VCV on lung mechanics, oxygenation, ventilation and intra-operative bleeding.  To compare the effects of respiratory mechanics after intubation under supine position, after proning, then at 20 minutes , 30 minutes, 60 minutes, 90 minutes, 120 mins , 150 minutes, 180 minutes, till the end of procedure 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the effect of these two modes of ventilation on hemodynamics.  To study the hemodynamic changes
I.e baseline & every 30 minutes. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   03/01/2025 
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="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  

Volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV) are two traditional ventilation modes in operating room, with different respiratory mechanics.  The two ventilation modes have different influences on intrathoracic pressure and consequently venous  return.During general anaesthesia, changing from supine to prone position may have adverse effects on oxygenation, ventilation and circulation.

         Prone position interferes with lung mechanics by decreasing the pulmonary       compliance and increasing the airway pressure1-3. High airway pressure may in turn impair venous return to heart, decrease cardiac output and increase the systemic venous pressure. Different modes of mechanical ventilation are used to balance respiratory mechanics, gas exchange and hemodynamics.

 

        Volume-controlled ventilation (VCV) has been widely used as a positive-pressure ventilation (PPV) method during anesthesia, but this method does increase airway pressure when chest compliance is decreased as occurs in during prone position surgeries. This increased airway pressure will be reflected as increased epidural venous pressure leading to increased surgical bleeding. On the other hand, pressure-controlled ventilation (PCV) limits the peak airway pressure (Ppeak) and reduces intrathoracic pressure thereby improving venous return and cardiac output.4

 

    However, advantage of PCV over VCV in improvement of oxygenation and ventilation has shown inconsistent results. To surgeons, the major problems encountered performing spine surgery are those of exposure and bleeding. To anaesthesiologists, the major problems noted in those patients are difficulties with ventilation and with cardiac dysfunction if the abdomen and chest are restricted.5

The present study aims to compare the effects of PCV with VCV on lung mechanics, oxygenation, ventilation and hemodynamics. 

 
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