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CTRI Number  CTRI/2014/11/005198 [Registered on: 12/11/2014] Trial Registered Retrospectively
Last Modified On: 19/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia
Diagnostic 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison between clinical assessment methods (hearing breath sounds with stethoscope) and lung ultrasonography to confirm position of double lumen tube (a device used to provide one lung ventilation) in elective thoracic surgeries at Tata Memorial Hospital. 
Scientific Title of Study   A prospective randomised controlled study to compare between clinical assessment methods and lung ultrasonography to confirm position of double lumen tube in elective thoracic surgeries involving one lung ventilation, at Tata Memorial Hospital. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Project no. 1351 version 1.0  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kailash Sharma 
Designation  Professor, Dept. of Anesthesia, Critical Care and Pain 
Affiliation  Tata memorial hospital 
Address  Dept. of Anesthesia, Critical Care and Pain Dr E Borges Marg, Parel, Mumbai, Maharashtra

Mumbai
MAHARASHTRA
400012
India 
Phone  9821161087  
Fax    
Email  rashmikailashsharma@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Swapnil Y Parab 
Designation  Assistant Professor 
Affiliation  tata memorial hospital 
Address  E Borges Road Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  9819319866  
Fax    
Email  swapnil.parab@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Swapnil Y Parab 
Designation  Assistant Professor 
Affiliation  tata memorial hospital 
Address  E Borges Road Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  9819319866  
Fax    
Email  swapnil.parab@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital 
 
Primary Sponsor  
Name  Tata Memorial Hospital Mumbai 
Address  Tata Memorial Hospital Dr E Borges Marg, Parel, Mumbai, Maharashtra 400012 
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 Kailash Sharma  Major Operation Theatre, Main Building,Tata memorial Hospital  Borges road, Parel ,Mumbai
Mumbai
MAHARASHTRA 
9821161087

rashmikailashsharma@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  100 adult patients undergoing elective thoracic surgeries, requiring one lung ventilation with use of DLT,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Clinical Assessment Group  • Observation of chest expansion and auscultation will be done by experienced OT anesthesiologist to confirm Bi Lung Ventilation or One Lung Ventilation 
Intervention  Lung Ultrasonography Group  Lung ultrasonography will be performed to confirm Bi Lung Ventilation or One Lung Ventilation with intercostal approach between 2nd and 4th ribs in the supramammary area in the midclavicular line and between 5th and 6th intercostal space in inframammary area in the anterior axillary line. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  100 adult patients undergoing elective thoracic surgeries, requiring one lung ventilation with use of DLT 
 
ExclusionCriteria 
Details  1.Patients with diagnosed pneumothorax or pleural effusion.
2.Patients with pleurodesis done in past.
3.Patients below the age of 18 years.
4.Patients with tracheostomy tube in situ.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
efficacy of the two methods i.e. clinical assessment and lung sonography respectively, to confirm lung isolation and position of DLT in elective thoracic surgeries involving one lung ventilation.
 
efficacy of the two methods i.e. clinical assessment and lung sonography respectively, to confirm lung isolation and position of DLT in elective thoracic surgeries involving one lung ventilation.
 
 
Secondary Outcome  
Outcome  TimePoints 
1.sensitivity, specificity, positive predictive value, negative predictive value and accuracy for each of the two methods i.e. clinical assessment and lung sonography respectively.
2.sensitivity and specificity of Lung pulse sign to detect lung atelectasis in elective thoracic surgeries involving one lung ventilation.
3.efficacy of lung ultrasonography to detect lobar atelectasis
 
1 year 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="70" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/11/2014 
Date of Study Completion (India) 20/04/2016 
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)
Modification(s)  
Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
A prospective randomized controlled double-blind study comparing auscultation and lung ultrasonography in the assessment of double lumen tube position in elective thoracic surgeries involving one lung ventilation at a tertiary care cancer institute. Parab SY, Kumar P, Divatia JV, Sharma K. Korean J Anesthesiol. 2019 Feb;72(1):24-31. doi: 10.4097/kja.d.17.00081. Epub 2018 Sep 12. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Lung-isolation techniques are primarily designed to facilitate one lung ventilation (OLV) in patients undergoing cardiac, thoracic, mediastinal, vascular, esophageal, or orthopedic procedures involving the chest cavity.  Lung isolation can be achieved by three different methods: double lumen tubes (DLT), bronchial blockers, or single-lumen endobronchial tubes. The most commonly used method is Double Lumen Tube. Nevertheless, malpositioning of the DLT is one of the most common problems and fiberoptic bronchoscopy has been recommended as a reliable method to avoid this complication. However, fiberoptic bronchoscopy is not always available. Fibreoptic bronchoscopy is an invasive method and carries risk of infection and airway trauma. Also, it demands expertise and knowledge of bronchial anatomy. Ultrasound has been proposed recently as a new method for detection of proper positioning of the endotracheal tube in critical care settings. Thoracic sonography can detect movement at visceral-parietal pleural interface (lung sliding) with normal ventilation while absence of such movement indicates lung collapse. Absence of lung sliding sign with demonstration of lung pulse (movement of pleura with cardiac activity) indicates complete atelectasis. These signs can be appreciated to confirm lung isolation in procedures involving OLV. This is a non-invasive, short, simple, bed side technique to confirm lung isolation following DLT placement and thus can confirm position of DLT. 

 
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