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CTRI Number  CTRI/2022/11/047084 [Registered on: 07/11/2022] Trial Registered Prospectively
Last Modified On: 06/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the use of ultrasound guided recruitment manoeuvre on lungs in patients undergoing laparoscopic abdominal surgery under general anaesthesia 
Scientific Title of Study   Evaluation of ultrasound guided lung recruitment manoeuvre on perioperative atelectasis in patients undergoing laparoscopic abdominal surgery under general anaesthesia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sajid K P 
Designation  Post graduate student 
Affiliation  Maulana Azad Medical College 
Address  Department of Aneasthesiology and Intensive care, Maulana Azad Medical College, Bahadur Shah Zafar marg New Delhi-02

New Delhi
DELHI
110002
India 
Phone  8903307573  
Fax    
Email  sajidkp.skp@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Munisha Agarwal 
Designation  Director professor 
Affiliation  Maulana Azad Medical College 
Address  Department of Aneasthesiology and Intensive care, Maulana Azad Medical College, Bahadur Shah Zafar marg New Delhi-02

New Delhi
DELHI
110002
India 
Phone  9968604216  
Fax    
Email  munisha.agarwal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sajid K P 
Designation  Post graduate student 
Affiliation  Maulana Azad Medical College 
Address  Department of Aneasthesiology and Intensive care, Maulana Azad Medical College, Bahadur Shah Zafar marg New Delhi-02

New Delhi
DELHI
110002
India 
Phone  8903307573  
Fax    
Email  sajidkp.skp@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology and Intesnsive care, Maulana Azad Medical College, Bahadur Shah Zafar marg, New Delhi-02 
 
Primary Sponsor  
Name  Maulana Azad Medical College 
Address  Maulana Azad Medical College Bahadur Shah Zafar marg New Delhi- 110002 
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 Sajid K P  Lok Nayak hospital  Department of Anaesthesia and Intensive care OT block Maulana Azad Medical College and associated Lok Nayak hospital Bahadur Shah Zafar marg New Delhi- 110002
New Delhi
DELHI 		 8903307573

sajidkp.skp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, MAMC  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  In the control group patients will receive PEEP of 5cmmH2O.  After intubation patients will be put on VCV mode of ventilation with PEEP of 5 cmmH2O throughout the surgery. 
Intervention  Lung recruitment manoeuvre  Ultrasound guided assessment of lung atelectasis is made and lung recruitment is done using incremental PEEP method. Lung recruitment will be carried out 5 minutes after creating pneumoperitoneum for the duration till aeration of areas of atelectasis or peak airway pressure of 40 cmH2O is achieved.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. ASA physical health status 1 and 2
2. Laparoscopic abdominal surgeries with expected duration of atleast one hour 
 
ExclusionCriteria 
Details  1. Patients with pre-existing lung disease, cardiovascular disease
2. patients with abnormal preoperative chest radiographs
3. patients with previous history of thoracic surgery
4. Surgeries requiring Trendelenburg position
5. Pregnancy
6. Morbid obesity (BMI more than 30 kg/m2)
7. Patients with increased intracranial pressure 
 
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 
Degree of lung atelectasis as assessed by lung ultrasound score at the end of surgery, with and without recruitment manoeuvre.  Time point T3 (at the end of surgery). 
 
Secondary Outcome  
Outcome  TimePoints 
1. Degree of lung atelectasis as assessed by lung ultrasound score at preoperative period, post-pneumoperitoneum and in post-anaesthesia care unit.
2. Incidence of intraoperative desaturation (SpO2 less than or equal to 94%)
3. Hemodynamic instability during recruitment manoeuvre 		 Time points - T1(preoperative period), T2(post-pneumoperitoneum), T4(in post-anaesthesia care unit) 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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)   07/11/2022 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   A study will be conducted on patients undergoing laparoscopic abdominal surgery under general anaesthesia, to evaluate the use of ultrasound guided lung recruitment manoeuvre on perioperative atelectasis. Using lung ultrasound score areas of atelectasis will be assessed and incremental increase of positive end-expiratory pressure will be applied as recruitment manoeuvre. Lung areation will be assessed at the end of surgery to evaluate the effect of recruitment manoeuvre. Data will be compared with another group who will be receiving a positive end-expiratory pressure of 5 cmH2O throughout the surgery. 
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