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CTRI Number  CTRI/2025/08/093164 [Registered on: 18/08/2025] Trial Registered Prospectively
Last Modified On: 15/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of mechanical power between Pressure Controlled ventilation versus Volume control ventilation in children undergoing laparoscopic surgery under general anesthesia A randomised controlled trial. 
Scientific Title of Study   Comparison of mechanical power between PCV vs VCV in children undergoing laparoscopic surgery under general anesthesia. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nishant Patel  
Designation  Associate Professor  
Affiliation  All India Institute of Medical Science  
Address  Department of Anaesthesiology,Pain medicine and Critical care,Room No.5007,Teaching block,AIIMS,Ansari Nagar South Delhi 110029 India

South
DELHI
11029
India 
Phone  8510955882  
Fax    
Email  Pateldrnishant@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nishant Patel  
Designation  Associate Professor  
Affiliation  All India Institute of Medical Science  
Address  Department of Anaesthesiology,Pain medicine and Critical care,Room No.5007,Teaching block,AIIMS,Ansari Nagar South Delhi 110029 India

South
DELHI
11029
India 
Phone  8510955882  
Fax    
Email  Pateldrnishant@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dadi Bote Nonang 
Designation  Junior Resident  
Affiliation  All India Institute of Medical Science  
Address  Department of Anaesthesiology,Pain medicine and ,Teaching block,AIIMS,Ansari Nagar South Delhi 110029 India

South
DELHI
110029
India 
Phone  7005667268  
Fax    
Email  dadbotnon@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology,Pain Medicine and Critical Care,AIIMS,New Delhi 
 
Primary Sponsor  
Name  AIIMS New Delhi  
Address  Department of Anaesthesiology,Pain Medicine and Critical Care,Ansari Nagar,New Delhi 110029 
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 Nishant patel  AIIMS, New Delhi  AB8,Department of Anaesthesiology, Pain Medicine and Critical care AIIMS, New Delhi
South
DELHI 
8510955882

pateldrnishant@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for Post Graduate Research   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   Positive End Expiratory Pressure,Tidal Volume,Inspiratory Pressure,Mechanical Power,Driving Pressure 
Comparator Agent  Volume controlled ventilation  Positive End Expiratory Pressure,Tidal Volume, Inspiratory Pressure,Mechanical Power, Driving Pressure 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1)age between 1 years and 12 years
2)ASA status I to III
3)elective laparoscopic surgery with a duration exceeding 1 hour 
 
ExclusionCriteria 
Details  1)Parental refusal to participate 2) History of severe cardiac and neurological diseases 3) History of severe lung disease (Pneumothorax, Pulmonary TB, Pleural effusion ) 4) children with known deformities of chest wall or thoracic spine 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
calculation of mechanical power on volume control mode in group V and pressure control mode in group P, derived by measuring the following Respiratory mechanics parameters: Following parameters will be measured
Driving pressure ,Peak airway pressure
Mean airway pressure, Plateau pressure
Static Lung compliance
 
after induction of anesthesia, before pneumoperitoneum,15 minutes after pneumoperitoneum,just after deflation of pneumoperitoneum  
 
Secondary Outcome  
Outcome  TimePoints 
1)Blood pressure- systolic blood pressure & Diastolic blood pressure
2)oxygen saturation (spo2) 
Every 15 minutes during the trial  
 
Target Sample Size   Total Sample Size="132"
Sample Size from India="132" 
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 
Date of First Enrollment (India)   28/08/2025 
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="3"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

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

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 01-02-2026 and end date provided 01-12-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

            Pressure-limited mode’s adaptability to compliance changes: PCV delivers breaths at a set pressure, adjusting the tidal volume based on the lung’s compliance. In laparoscopic surgeries where pneumoperitoneum affects compliance due to increased intra-abdominal pressure, PCV might result in lower mechanical power as it adapts to these compliance changes more dynamically than VCV.

             Tidal volume variability: VCV delivers a set tidal volume regardless of changes in lung compliance, potentially leading to higher delivered tidal volumes in situations with decreased lung compliance (as in laparoscopic surgeries with pneumoperitoneum). This could result in increased mechanical power in VCV due to higher tidal volumes against less compliant lungs.

       Peak airway pressures: In laparoscopic surgeries, increased intra-abdominal pressure from insufflation of carbon dioxide can increase peak airway pressures. PCV, by limiting pressure, might lead to lower peak airway pressures compared to VCV. Lower peak pressures might contribute to reduced lung injury risk and subsequently lower mechanical power in PCV.

          Intrinsic PEEP: VCV might generate higher intrinsic Positive End-Expiratory Pressure (PEEP) due to its fixed tidal volume delivery, especially in conditions like laparoscopic surgeries where dynamic changes in compliance occur. This increased PEEP can contribute to higher mechanical power compared to PCV, which may have lower or more adjustable PEEP levels.

                  Optimal distribution of ventilation: PCV may facilitate better distribution of ventilation in conditions like laparoscopic surgeries where there might be compromised lung compliance due to altered positioning, such as Trendelenburg or reverse Trendelenburg positions. Improved ventilation distribution might reduce the need for higher pressures, thus lowering mechanical power.

             Respiratory system mechanics and energy expenditure: By adapting to changes in lung compliance, PCV might be more efficient in reducing energy expenditure and mechanical work on the respiratory system compared to VCV, particularly in conditions of altered lung mechanics during laparoscopic surgery.

These rationales suggest that PCV might offer advantages in adapting to changing compliance, providing more stable pressures, and potentially reducing mechanical power compared to VCV in the context of laparoscopic surgeries in pediatric patients. However, empirical research through controlled trials or retrospective studies comparing these ventilation modes in this specific surgical setting is necessary to validate these hypotheses.

 
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