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
|
|
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
|
|
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
|
|
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. |