| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- 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.
- 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. |