| CTRI Number |
CTRI/2025/09/094777 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
14/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of the difference in carbon dioxide level in arterial blood to exhaled carbon dioxide in patients who undergo key hole kidney surgery under general anaesthesia in two different modes of ventilator. |
|
Scientific Title of Study
|
Comparison of PaCO2 to ETCO2 gradient in volume vs pressure control ventilation in patients undergoing laparoscopic renal surgeries in the lateral decubitus position. |
| 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 Sindhu Balakrishnan |
| Designation |
Professor |
| Affiliation |
Amrita Institute of Medicsl Science,Kochi |
| Address |
Department of Anesthesiology,
Amrita Institute of Medical Science,
Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9895148416 |
| Fax |
|
| Email |
sindhuskumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sindhu Balakrishnan |
| Designation |
Professor |
| Affiliation |
Amrita Institute of Medicsl Science,Kochi |
| Address |
Department of Anesthesiology,
Amrita Institute of Medical Science,
Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9895148416 |
| Fax |
|
| Email |
sindhuskumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Joseph |
| Designation |
Junior Resident |
| Affiliation |
Amrita Institute of Medical Science ,Kochi |
| Address |
Department of Anaesthesiology,
Amrita Institute of Medical Science,Kochi
Ernakulam
KERALA
682041
India |
| Phone |
8138852085 |
| Fax |
|
| Email |
pichirox11@gmail.com |
|
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Source of Monetary or Material Support
|
| Amrita Institute of medical Science,
Kochi,Kerala,India,682041 |
|
|
Primary Sponsor
|
| Name |
Amrita Institute of Medical Sciences |
| Address |
AIMS,Ponnekkara P.O,Kochi
682041,Kerala |
| Type of Sponsor |
Private medical college |
|
|
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 Sindhu Balakrishnan |
Amrita Institute of Medical Science,Kochi |
Operation Theatre,Department of Anesthesiology
Ernakulam
KERALA |
9895148416
sindhuskumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Amrita School of Medicine |
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: N288||Other specified disorders of kidney and ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Compares the arterial and end tidal carbon dioxide gradient between two modes of ventilation. |
General anesthesia will be induced using standard induction drugs for laparoscopic nephrectomy surgeries.Postinduction an arterial cannula will be placed for BP monitoring and ABG analysis.Patients will be randomised using computer generated random number into two groups.One group will be under volume control and the other group will be under pressure control mode of ventilation under GA.Ventilator settings will be according to the predicted body weight.The ABG to analyse PaCO2 and EtCO2 will be monitored at 8 different time points i.e before,during and after pneumoperitoneum and various parameters are compared at these time points.The effect of two different ventilatory modes ie pressure control and volume control is noted on the following parameters.These parameters include arterial and end tidal carbon di oxide gradient,peak airway pressure and dynamic compliance,alevolar arterial oxygen gradient,hemodynamic changes and Paco2 Etco2 gradient based on different surgical techniques like intraperitoneal and retroperitoneal. |
| Intervention |
Using either of the two modes of ventilation under GA for laparoscopic nephrectomy surgeries and arterial sample will be sent at various time points to note the effect of ventilation on the gradient. |
This study compares the PaCO2 EtCO2 gradient between volume vs pressure control ventilation for laparoscopic nephrectomy surgeries done in lateral decubitus position.Post induction an arterial will placed for BP monitoring and ABG analysis.Patients will be randomised into 2 modes of ventilation i.e either pressure control or volume control.Ventilator settings will be adjusted according to predicted body weight.The EtCO2 will be noted 15 seconds before collecting arterial sample.Arterial sample is sent at 8 different time points ie before during and after pneumoperitoneum to compare the effect of the two modes of ventilation on different parameters.These time points include
stage 1 before pneumoperitoneum
T1a-10 minutes after induction when patient is hemodynamically stable
T1b-10 minutes after placing patient in lateral decubitus position and prior to CO2 insufflation
stage 2 during pneumoperitoneum
T2a-30 minutes after CO2 insufflation
T2b-60 minutes after CO2 insufflation
T2c-90 minutes after CO2 insufflation
T2d-120 minutes after CO2 insufflation
stage 3 after release on pneumoperitoneum
T3a-10 minutes after release of CO2
T3b-10 minutes after patient is made supine at end of procedure. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA I,II,III
|
|
| ExclusionCriteria |
| Details |
Obesity with BMI more than 30
Active Smoking
Moderate to Severe COPD
Emergency Nephrectomy
Conversion to open surgery |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of two different ventilatory modes i.e pressure control ventilation and volume control ventilation on the PaCO2 to EtCO2 gradient during laparoscopic nephrectomy in lateral decubitus position at T2c time point. |
T2c time point is 90 minutes after creation of pneumoperitoneum intraop. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Peak airway pressure & dynamic compliance between two modes of ventilation. |
At 8 different time points.
T1a-10 minutes after induction when patient is hemodynamically stable
T1b-10 minutes after placing the patient in lateral position & prior to CO2 insufflation.
T2a-30 minutes during period of pneumoperitoneum
T2b-60 minutes during period of pneumoperitoneum
T2c-90 minutes during period of pneumoperitoneum
T2d-120 minutes during period of pneumoperitoneum
T3a-10 minutes after release of pneumoperitoneum
T3b -10 minutes after patient is made supine at end of procedure |
| Difference in alveolar arterial oxygen gradient between two modes. |
At 8 different time points
T1a-10 minutes after induction when patient is hemodynamically stable
T1b-10 minutes after placing patient in lateral position & prior to CO2 insufflation
T2a-30 minutes during period of pneumoperitoneum
T2b-60 minutes during period of pneumoperitoneum
T2c-90 minutes during period of pneumoperitoneum
T2d-120 minutes during period of pneumoperitoneum
T3a-10 minutes after release of pneumoperitoneum
T3b-10 minutes after patient is made supine at end of procedure |
| To compare hemodynamic changes in the two groups. |
At 8 different time points
T1a-10 minutes after induction when patient is hemodynamically stable
T1b-10 minutes after placing the patient in lateral position & prior to CO2 insufflation
T2a-30 minutes during period of pneumoperitoneum
T2b-60 minutes during period of pneumoperitoneum
T2c-90 minutes during period of pneumoperitoneum
T2d-120 minutes during period of pneumoperitoneum
T3a-10 minutes after release of pneumoperitoneum
T3b-10 minutes after patient is made supine at end of procedure. |
| To study the PaCO2 to EtCO2 gradient in different surgical techniques i.e intraperitoneal & retroperitoneal approach. |
At 8 different time points
T1a-10 minutes after induction when patient is hemodynamically stable
T1b-10 minutes after placing the patient in lateral position & prior to CO2 insufflation
T2a-30 minutes during period of pneumoperitoneum
T2b-60 minutes during period of pneumoperitoneum
T2c-90 minutes during period of pneumoperitoneum
T2d-120 minutes during period of pneumoperitoneum
T3a-10 minutes after release of pneumoperitoneum
T3b-10 minutes after patient is made supine at end of procedure. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/09/2025 |
| 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
|
This is a prospective randomised control study that compares the PaCO2 to EtCO2 gradient in volume vs pressure control ventilation in patients undergoing laparoscopic renal surgeries in lateral decubitus position 90 minutes after creation of pneumoperitoneum. Secondary objective includes comparing airway pressure and dynamic compliance ,Arterial alveolar oxygen gradient, hemodynamic changes and PaCO2 to EtCO2 gradient in different surgical techniques that is intraperitoneal and retroperitoneal approach at 8 different time points. This study includes patients ASA I to III aged between 18-80 years but excludes patients with BMI more than 30, emergency nephrectomy, moderate to severe COPD and active smokers. In healthy individuals this gradient is less than 5 mm of Hg. Variations can be seen depending on patients underlying condition, position adopted for surgery and surgery itself. ABG will be analysed using arterial blood and EtCO2 value should be obtained 15 seconds prior to this. Samples are collected at 8 different time points that is before during and after pneumoperitoneum. It was seen in most studies Pressure control mode of ventilation was assosciated with lower airway pressure, higher mean pressure and improved dynamic compliance compared to Volume control. Pressure Control Ventilation improves oxygenation without any side effects and generates higher instantaneous flow peak allowing better alveolar recruitment. |