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CTRI Number  CTRI/2018/01/011516 [Registered on: 23/01/2018] Trial Registered Retrospectively
Last Modified On: 20/01/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Single Arm Study 
Public Title of Study   Chest Ultrasonography for assessing degree of lung collapse during Robotic lower abdominal Surgeries. 
Scientific Title of Study   Lung Ultrasound Imaging for assessing degree of atelectasis during Robotic Pelvic Suegeries. 
Trial Acronym  LUS  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anita Kulkarni 
Designation  Senior Consultant Anaesthesia 
Affiliation  Rajiv Gandhi Cancer Institiute and Research Centre 
Address  Depatrment of Anesthesiology OT Block III rd Floor Old Building sector V Rohini Delhi

North
DELHI
110085
India 
Phone  9891064785  
Fax    
Email  anitackulkarni@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anita Kulkarni 
Designation  Senior Consultant Anaesthesia 
Affiliation  Rajiv Gandhi Cancer Institiute and Research Centre 
Address  Department of Anesthesiology OT Block III rd Floor Old buiding Sector V Rohini Delhi

North
DELHI
110085
India 
Phone  9891064785  
Fax    
Email  anitackulkarni@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anita Kulkarni 
Designation  Senior Consultant Anaesthesia 
Affiliation  Rajiv Gandhi Cancer Institiute and Research Centre 
Address  Department of Anesthesiology OT Block IIIrd Floor Old Building Sector V Rohini Delhi

North
DELHI
110085
India 
Phone  9891064785  
Fax    
Email  anitackulkarni@gmail.com  
 
Source of Monetary or Material Support  
Rajiv Gandhi Cancer Institiute and Research Centre Sector V Rohini New Delhi India 110085 
 
Primary Sponsor  
Name  Rajiv Gandhi Cancer Institiute and Research Centre 
Address  Department of Anesthesiology OT Block III FLOOR OLD Building Sector V Rohini New Delhi 110085  
Type of Sponsor  Research institution and hospital 
 
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 Anita Kulkarni MD  Rajiv Gandhi Cancer Institute and Research Centre.   Department of Anesthesiology OT Block IIIrd Floor Old Buiding Sector V Rohini
North
DELHI 		 09891064785

anitackulkarni@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rajiv Gandhi Cancer Institute and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients posted for robotic pelvic surgeries (ASA I,II,III) with duration of surgery more than 2 hours , requiring pneumoperitoneum and steep trendelenburg position.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients scheduled for robotic pelvic surgeries under general anesthesia requiring pneumoperitoneum and steep trendelenberg position . 
 
ExclusionCriteria 
Details  Preoperative lung consolidation, severe COPD, previous thoracic procedure, BMI>28, cardiomyopathy with decreased systolic ejection fraction. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To estimate degree of lung atelectasis using aeration score by ultrasound imaging .  T1 - Baseline Lung US Imaging in 6 basal zones and aeration score (3 in each lung )5 minutes after induction of anaesthesia and before docking of robotic instruments.
T2 - Lung US Imaging in 6 basal zones and aeration score (3 in each lung ) 5 minutes after the end of robotic surgery and dedocking of robotic instruments. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess impact of robotic surgery on gas exchange by measuring arterial blood gases.  Ta - ABG 5 minutes after induction of anaesthesia and before docking of robotic intruments.
Tb - ABG 5 minutes after the end of robotic surgery and dedocking of robotic instruments. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/12/2015 
Date of Study Completion (India) 28/12/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Cecilia M .Acosta ,Gustavo A.Maidana ,Daniel Jacovitti ,Agustin Belanunzaran ,SilvanaCereceda :Accuracy of Transthoracic Lung Ultrasound for Diagnosing Anesthesia-Induced Atelectasis in Children , Anesthesiology 2014;120 : 1370-9 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary             Introduction  - General anaesthesia results in developement  of  atelectasis in dependent areas of the  lungs exposing patients to an increased risk of hypoxaemia.During  pelvic robotic surgeries pneumoperitoneum and steep trendelenburgh  position further  increases atelectasis. Lung Ultrasound imaging is a promising , noninvasive , non-radiant, portable tool to study intraoperative lung atelectasis.
Type of Study : This study is prospective, interventional,observational single centre study.
  Aims and Objectives ( i ) To study the degree of anaesthesia induced atelectasis with Lung Ultrasound Imaging  in patients undergoing pelvic robotic surgery. (ii) To demonstrate a link between a four point lung aeration score and Pao2 /Fio2  Ratio  . Procedure -In OT Standard monitoring will be attached ,under LA  radial artery cannulation will be performed  , Conventional  general anesthesia with oral cuffed ETT and IPPV wil be provided to all patients.
T1 -Baseline Lung Ultrasound Imaging  using 4 point Lung aeration score ( 0= Normal lung , 1= moderate aeration loss, 2=severe  aeration loss ,3=complete aeration loss and consolidation. will be noted in 3 basal zones in both lungs 5 minutes after induction of anaesthesia  and before docking robotic instruments. T2 Lung Ultrasound Imaging and aeration score noted at the end of robotic surgery 5 minutes after dedocking robotic instruments in 3 basal zones in both lungs.Ta Arterial blood gas 5 minutes after induction of anesthesia and before docking robotic instruments.Tb -Arterial blood gas 5 minutes after the end of  robotic surgery and dedocking robotic instruments.All patients will recieve PEEP 5 cms H2O intraoperatively . Any decrease in Oxygen saturation and intervention required will be noted.  Expected  primary outcome To diagnose  degree of lung atelectasis in robotic pelvic surgeries with lung aeration score more than 1 in basal areas .Secondary outcome decrease in PaO2 / Fio2 ration at the end of pelvic robotic surgery compared to baseline values.
 
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