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CTRI Number  CTRI/2024/11/077178 [Registered on: 21/11/2024] Trial Registered Prospectively
Last Modified On: 20/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   The amount of pressure applied inorder to keep alveoli during inflation of abdomen with carbondioxide inorder to improve oxygenation 
Scientific Title of Study   Optimal individual positive end expiratory pressure during mechanical ventilation in patients undergoing laparoscopic surgery: A clinical 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  SK ANJALI 
Designation  POST GRADUATE 
Affiliation  K. S. HEGDE MEDICAL ACADEMY 
Address  DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, JUSTICE KS HEGDE MEDICAL ACADEMY, DERALAKATTE MANGALORE

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8861437900  
Fax    
Email  skanjalikarthi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  SRIPADA G MEHANDALE 
Designation  HOD AND PROFESSOR DEPARTMENT OF ANAESTHESIOLOGY 
Affiliation  K. S. HEGDE MEDICAL ACADEMY 
Address  DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, JUSTICE KS HEGDE MEDICAL ACADEMY, DERALAKATTE MANGALORE

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9448384310  
Fax    
Email  hod.anae.kshema@nitte.edu.in  
 
Details of Contact Person
Public Query
 
Name  SRIPADA G MEHANDALE 
Designation  HOD AND PROFESSOR DEPARTMENT OF ANAESTHESIOLOGY 
Affiliation  K. S. HEGDE MEDICAL ACADEMY 
Address  DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, JUSTICE KS HEGDE MEDICAL ACADEMY, DERALAKATTE MANGALORE

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9448384310  
Fax    
Email  hod.anae.kshema@nitte.edu.in  
 
Source of Monetary or Material Support  
JUSTICE K. S. HEGDE MEDICAL ACADEMY, DERALAKATTE MANGALURU 
 
Primary Sponsor  
Name  S K ANJALI 
Address  JUSTICE K. S. HEGDE MEDICAL ACADEMY DERALAKATTE, MANAGALURU 
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 
S K ANJALI  K. S . HEGDE MEDICAL ACADEMY  DEPARTMENT OF ANAESTHESIOLOGY, JUSTICE K.S. HEGDE MEDICAL ACADEMY DERALAKATTE MANGALURU
Dakshina Kannada
KARNATAKA 
08861437900

skanjalikarthi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, K. S. HEGDE MEDICAL ACADEMY   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K928||Other specified diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Adult patient, aged 18-60 years
2. ASA-PS grade:I TO III
3. Patients undergoing laparoscopic surgeries
4. Patients undergoing endotracheal general anaesthesia with mwchanical ventilation 
 
ExclusionCriteria 
Details  1. Contraindication to the application of PEEP: untreated pneumothorax, tension pneumothorax, bronchopleural fistula, high intracranial pressure, shock etc
2. Severe chronic obstructive pulmonary disease (COPD, GOLD classification III-IV)
3. History of severe or uncontrolled bronchial asthma
4. Preoperative hemodynamic instability
5. Suspected intolerance to PEEP titration 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To find out optimal PEEP in patients undergoing laparoscopic sugery under general anaesthesia using static compliance method  RM1- 5 minutes after inytubation
RM2- 5 minutes after establishmnet of pneumopoeritoneum
RM3- after deflation of pneumoperitoneum before extubation 
 
Secondary Outcome  
Outcome  TimePoints 
1.To find out if there are any hemodynamic changes after applying PEEP
2. To find out any changes in optimal PEEP at different stages of surgeries 
RM1- 5 minutes after inytubation
RM2- 5 minutes after establishmnet of pneumopoeritoneum
RM3- after deflation of pneumoperitoneum before extubation 
 
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)   01/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/12/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
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  
Post operative pulmonary complications can cause huge burden on the cost of the treatment
especially after major abdominal surgeries, which includes pneumonia, pulmonary oedema,
pulmonary thromboembolism, atelectasis, and acute exacerbation of COPD.  Many of the
predisposing factors are either related to the patient condition or surgical procedure, hence
anaesthesiologist have very little role in modifying the same favorably. Of the five risk
factors identified as predisposing factors for post operative pneumonia, none were
modifiable. 
Of all strategies to minimize postoperative pulmonary complication, a combination of low
tidal volume ventilation, application of optimal PEEP and institution of recruitment
manoeuvre has been advocated. 
However, there is no agreement regarding the optimal peep during IPPV, therefore it is
required to be determined before initiation of mechanical ventilation in every instance. 6
This is cumbersome and time consuming, which may make it less practical for routine
implementation. Hence, the current study is undertaken to determine most common optimal
peep among surgical patient undergoing elective laparoscopy.

PROCEDURE
This cross-sectional observational study will be conducted after obtaining approval from the
Institutional Ethics Committee. A pre-anaesthetic evaluation with a detailed medical history,
systemic examination and airway examination will be done and reviewed on the previous day
and on the day of surgery. Informed and written consent will be obtained from the patient
and/or the patient’s guardian. Patient will be kept nil per oral for 6 hours and premedicated
according to standard institutional protocol.
Once the patient is shifted to the operation theatre, standard monitors like electrocardiogram,
pulse oximetry (SpO 2 ), non-invasive blood pressure, and end tidal capnography will be
initiated. Intravenous fluid will be started after securing a suitable intravenous cannula at a
rate of 100 ml/h. Patients will receive endotracheal general anaesthesia as per the institutional
protocol, which includes preoxygenation for three minutes, intravenous fentanyl 2 µg/kg,
propofol 2 mg/kg (or titrated to loss of verbal response, whichever is less), vecuronium 0.1
mg/kg for facilitating the endotracheal intubation and intermittent positive pressure
ventilation (IPPV) for three minutes or till TOF (train of four) count becomes zero. A suitable
sized endotracheal tube will be placed and its position will be confirmed. Anaesthesia will be
maintained with a mixture of air and oxygen (not less than 33%) with isoflurane to maintain
the required depth of anaesthesia. Dexmedetomidine (1µ/kg, intravenous, over not less than
10 min) may be used to obtund the sympathetic response to pneumoperitoneum during the
procedure. Patient’s lung will be ventilated on volume control mode (VCV) with positive end
expiratory pressure (PEEP) of 5 cmH 2 O, a respiratory rate of 12 to 15 breaths per minute
(BPM), a tidal volume of 7 ml/kg (TV), and I:E ratio of 1:1. The respiratory rate will be
adjusted to maintain the end tidal CO 2 between 30 and 35 mmHg. During the RM, the
maximum limit to the PAP will be kept at 50 cmH 2 O and maximum plateau pressure at 40
cmH 2 O.

The ideal PEEP will be determined using following procedure:
1. V t will be set to 7 ml/kg body weight, respiratory rate to 12 to 15 breaths/min.
2. The initial PEEP will be set to 5 cmH 2 O, then the PEEP will be increased at steps of
one cmH 2 O, and each PEEP level will be sustained for 3 min. While adjusting the
PEEP, Cstat will be calculated using formula (Cstat=V t /(Pplat-PEEP) until the
calculated Cstat shows a declining trend. The PEEP corresponding to the calculated
maximum Cstat will be set as the optimal iPEEP for this patient.
3. The upper limit of PEEP to be tried will be 20 cmH2O.
4. A maintenance infusion of IV fluid (Ringer’s lactate or normal saline) will be infused
at a rate of 100 ml/h. During RM, if any hypotension is noted (systolic blood pressure
less than 90 mmHg or MAP less than 70 mmHg), a bolus of 200 ml of maintenance
fluid will be infused. If hypotension persists, bolus of vasopressors like
mephentermine or phenylephrine will be given to maintain the BP.
The first recruitment manoeuvre (RM1) will be performed 5 min after intubation.
The second recruitment manoeuvre (RM2) will be performed five minutes after establishing
pneumoperitoneum.
The third recruitment manoeuvre (RM3) will be performed after deflation of
pneumoperitonium before extubation.
 
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