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CTRI Number  CTRI/2018/07/014954 [Registered on: 18/07/2018] Trial Registered Prospectively
Last Modified On: 09/08/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To find out effect of lung exansion method on lung collapse (A common problem i all the patient who undergo gall bladder sugery through laparoscopy) with the help of ultrasound in the patient who are undergoing gall bladder surgery through laparoscopic method.  
Scientific Title of Study   Point of care ultrasonography to evaluate the effect of pre-extubation lung recruitment maneuver on perioperative atelectasis in patients undergoing laparoscopic cholecystectomy  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DEVENDRA GUPTA 
Designation  Professor 
Affiliation  SGPGIMS, LUCKNOW (INDIA0 
Address  Department of Anaesthesiology, Lucknow.
Department of Anaesthesiology, Lucknow.
Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904596  
Fax  05222668017  
Email  drdevendragpt@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  DEVENDRA GUPTA 
Designation  Professor 
Affiliation  SGPGIMS, LUCKNOW (INDIA0 
Address  Department of Anaesthesiology, Lucknow.
Department of Anaesthesiology, Lucknow.
Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904596  
Fax  05222668017  
Email  drdevendragpt@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nitin Gupta 
Designation  MD student 
Affiliation  SGPGIMS, LUCKNOW (INDIA0 
Address  Department of Anaesthesiology, Lucknow.
Department of Anaesthesiology, Lucknow.
Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904609  
Fax  05222668017  
Email  drnitin1983@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, SGPGIMS, Lucknow 
 
Primary Sponsor  
Name  SANJAY GANDHI POSTGRADUATE INSTITUTE OF MEDICAL SCIENCES LUCKNOW 
Address  Department of Anaesthesiology, SGPGIMS, Lucknow 
Type of Sponsor  Research institution 
 
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 Devendra Gupta  Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow  Department of Anaesthesiology (BLOCK A) SGPGIMS
Lucknow
UTTAR PRADESH 
8004904596
05222668017
drdevendragpt@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, Patient undergoing laparoscopic cholecystectomy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Alveolar recruitment group 10 (group III):   PEEP of 10 cm of H2O will be applied 10 min before extuation and will be maintained till extubation. 
Intervention  Alveolar recruitment group 5 (group II):   PEEP of 5 cm of H2O will be applied 10 min before extuation and will be maintained till extubation 
Comparator Agent  Control  No application of PEEP or alveolar recruitment before extubation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of age of 18 to 60 years , of either sex, belonging to ASA physical status of I and II undergoing laparoscopic cholecystectomy surgery under General anesthesia.  
 
ExclusionCriteria 
Details  Patient with morbid obesity, history of smoking or chronic respiratory disease, bronchial asthma, cardiac, pulmonary, renal or neuromuscular disorders, contraindication of laparoscopic surgery and patient with history of previous abdominal surgery will be excluded from this study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
the effect of different lung recruitment maneuvers on modified lung ultrasound score.   Images will be obtained at 5 predefined time points: before GA induction (time point A), 5 minutes after GA induction (time point B), after pneumoperitoneum and before recruitment maneuver (time point C), 10 minutes after the arrival of patients in the recovery room (time point D), and 60 minutes after the arrival of patients in the recovery room or immediately before the discharge from the recovery room (time point E). 
 
Secondary Outcome  
Outcome  TimePoints 
Postoperative complications and pain score  Immediate postoperative period and at the time of discharge from postoperative ward 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   18/07/2018 
Date of Study Completion (India) 30/10/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   No publication of such study nor registered so far any clinical trial registry 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Objective:

Pneumoperitoneum resulted into alteration in gas exchange is due to intraoperative atelectasis resulting in collapse of alveoli and increase in resistance of airways which leads to intrapulmonary shunting, ventilation perfusion mismatch and ultimately arterial hypoxemia. In a recent pilot study on the model of laparoscopic surgery-induced atelectasis demonstrated the feasibility of lung ultrasonography during the perioperative period. Lung ultrasonography also allowed the tracking of perioperative atelectasis and facilitates the diagnosis of respiratory complications. Studies demonstrated that in patients undergoing laparoscopic cholecystectomy, the open lung approach was suitable for bedside PEEP setting, improved lung mechanics and gas exchange without significant adverse hemodynamic effects.

We therefore planned a study to evaluate effect of different lung maneuver on modified lung ultrasound score with the use of point of care lung ultrasound during laparoscopic cholecystectomy.

Methods

This prospective randomized double blind controlled study will be conducted in patients of age of 18 to 60 years , of either sex , belonging to ASA physical status of I and II undergoing laparoscopic cholecystectomy surgery under GA. Patient with morbid obesity, history of smoking or chronic respiratory disease, bronchial asthma, cardiac, pulmonary, renal or neuromuscular disorders, contraindication of laparoscopic surgery and patient with history of previous abdominal surgery will be excluded from this study

 

All patients will be given anesthesia as per departmental protocol. Tidal volume will be set at 8ml/kg of predicted body weight, FiO2 0.40, respiratory rate of 12 / minute adjusted to obtain an end tidal carbon dioxide 35+ 2, inspiratory to expiratory ratio of 1:2, and no positive end-expiratory pressure (PEEP). Pneumoperitoneum during laparoscopic cholecysytecomy will be maintained with co2 insufflated in abdomen to pressure of 15 mm of Hg.

 

Depending upon the computer generated random number patient has been assigned the any of the three groups. In control group (group I): No application of PEEP or alveolar recruitment before extubation. In Alveolar recruitment group 5 (group II): PEEP of 5 cm of H2O will be applied 10 min before extubation and will be maintained till extubation. Alveolar recruitment group 10 (group III): PEEP of 10 cm of H2O will be applied 10 min before extubation and will be maintained till extubation. For safety reason, working pressure of ventilator will be limited to 30cm of H2O. PEEP will be increased to desired level after obtaining the information of hemodynamic state of the individual patient. Lung ultrasonography will be performed by 2 trained echographists (DG and RV respectively, with 10 years and 3 years of experience in lung ultrasonography) using a convex array 2- to 5-MHz transducer. Aeration loss will be assessed by calculating the modified LUS score in each of the 12 quadrants. Images will be obtained at 5 predefined time points: before GA induction (time point A), 5 minutes after GA induction (time point B), after pneumoperitoneum and before recruitment maneuver (time point C), 10 minutes after the arrival of patients in the recovery room (time point D), and 60 minutes after the arrival of patients in the recovery room or immediately before the discharge from the recovery room  (time point E). Care will be taken to set the focal zone on the pleural line. No second harmonic imaging will be used. Thorax will be divided into 12 quadrants (Figure 1): anterior, lateral, and posterior zones (separated by the anterior and posterior axillary lines) each divided in upper and lower portions for the right and left lung. Intercostal spaces of each of these areas will be scanned and a cine-loop of the most pathologic area of each quadrant will be saved to digital format for offline analysis.

Primary outcome will be the effect of different lung recruitment maneuvers on modified lung ultrasound score. Secondary outcome will be postoperative complications and pain score. To test the effect of different lung recruitment maneuvers on modified LUS, sample size will be taken 30 patients in each of the three study groups with total of 90 patients.

 
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