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CTRI Number  CTRI/2024/09/074026 [Registered on: 19/09/2024] Trial Registered Prospectively
Last Modified On: 18/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A trial to compare the effect of conventional and individualized peak end expiratory pressure on kinetics of inflammatory biomarkers in obese patients undergoing laparoscopic surgeries 
Scientific Title of Study   A randomized control trial to compare the effect of conventional and individualized peak end expiratory pressure on kinetics of inflammatory biomarkers in obese patients undergoing laparoscopic surgeries 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Garima Agrawal 
Designation  Professor 
Affiliation  Lady Hardinge Medical College 
Address  Department of Anaesthesia, Lady Hardinge Medical College, shahid Bhagat Singh Marg, Delhi

Central
DELHI
110001
India 
Phone  8826640501  
Fax    
Email  garima2396@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shubhangi Sudan 
Designation  Post graduate student 
Affiliation  Lady Hardinge Medical College 
Address  Department of Anaesthesia, Lady Hardinge Medical College, shahid Bhagat Singh Marg, Delhi

Central
DELHI
110001
India 
Phone  9149449862  
Fax    
Email  shubhangisudan12@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shubhangi Sudan 
Designation  Post graduate student 
Affiliation  Lady Hardinge Medical College 
Address  Department of Anaesthesia, Lady Hardinge Medical College, shahid Bhagat Singh Marg, Delhi

Central
DELHI
110001
India 
Phone  9149449862  
Fax    
Email  shubhangisudan12@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia, Lady Hardinge Medical College, shahid Bhagat Singh Marg, central Delhi 110001 
 
Primary Sponsor  
Name  Lady Hardinge Medical College 
Address  Lady Hardinge Medical College New Delhi 110001 
Type of Sponsor  Government 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 Shubhangi Sudan  Lady hardinge medical college  Department of anaesthesia, lady hardinge medical college and associated hospital
Central
DELHI 		 9149449862

shubhangisudan12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Lady Hardinge Medical College and associated hospitals New Delhi  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 
Comparator Agent  Conventional PEEP  Setting conventional PEEP as per ARDS net protocol 
Intervention  Individualised PEEP  Setting up individualised PEEP just after induction of anaesthesia and at 5 minutes of creating pneumoperitonium 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Body Mass Index (BMI)≥30kg/m2 and American Society of Anesthesiologists (ASA) Physical Status I–III, undergoing laparoscopic general surgery of 2-4 hours duration. 
 
ExclusionCriteria 
Details  1. Patients with history of any lung disease.
2. Recent infections, recent ventilatory support.
3. Use of immunosuppressive medication.
4. History of smoking in the past 8 weeks.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean/median of change in level of interleukin 6 and surfactant protein D from baseline to post operative day 1 in conventional PEEP vs individualised PEEP in obese patients undergoing laparoscopic surgery  Post operative day 1 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of patients developing post op pulmonary complications in the two groups
Correlation between the kinetics of inflammatory bio markers and occurrence of post operative pulmonary complications  		 Before the surgery
On post operative day one of surgery  
 
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)   15/10/2024 
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="2"
Days="1" 
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  
Globally there is an increase in the incidence of obesity and according to WHO, more than 650 million people were obese in 2016 leading to a proportionate rise in number of obese patients undergoing surgical procedures. Under general anaesthesia and paralysis there is a decrease in lung compliance and  functional residual capacity (FRC) with loss of diaphragmatic tone leading to decrease in oxygen reserve and ventilation-perfusion mismatch. Pneumoperitoneum created for laparoscopic surgery causes a cephalic shift of diaphragm and elevates pleural pressure which increases lung atelectasis and the risk of post operative pulmonary complications(PPCs). The incidence of PPCs in obese patients (18-23%) is almost twice that of normal population. It is widely known that PPCs cause a significant increase in  the length of Intensive care unit (ICU) and hospital stay.
The plasma kinetics of inflammation and lung injury biomarkers such as IL-6, SP-D,TNF-α,  IL-8, sRAGE,  CC-16, and KL6 help in identifying patients at risk of developing PPCs  but the change in the level depends upon various factors such as preoperative lung condition and  intra-operative ventilatory settings. Various lung protective stratergies have been suggested to decrease postoperative pulmonary atelectasis such as low tidal volumes (VT), individualized positive end-expiratory pressure (PEEP), recruitment manoeuvre (RM).
PEEP is the alveolar pressure above atmospheric pressure that exists at the end of expiration. Various advantages of PEEP are increase in lung compliance, prevention of alveolar collapse, improvement of oxygen diffusion thereby improving pulmonary dynamics  and gas exchange. However, PEEP has certain adverse effects such as overdistention of alveoli (barotrauma), decrease in the cardiac output, unintended respiratory alkalosis. Many approaches to titrate PEEP have been proposed such as using PEEP tables (high or low), measuring compliance (static or dynamic), plateau pressure, pressure-volume curve and inflection points and esophageal balloons to measure transpulmonary pressure. 
PPCs can be considered as a composite outcome measure which includes respiratory infection, respiratory failure, plueral effusion, atelectasis, etc as per European Perioperative Clinical Outcome(EPCO). Post operative pulmonary atelectasis is best identified using various imaging modalities such as CT, ultrasound or electric impedance tomography but may not be always feasible for every patient.


 
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