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CTRI Number  CTRI/2024/12/078127 [Registered on: 16/12/2024] Trial Registered Prospectively
Last Modified On: 12/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of 110 degree rotation with 90 degree rotation for left double lumen tube placement 
Scientific Title of Study   Comparison of 110 degree anticlockwise rotation and conventional 90 degree rotation for successful placement of left double-lumen tubes: A randomised controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Subodh Kumar 
Designation  ASSISTANT PROFESSOR 
Affiliation  AIIMS, New Delhi 
Address  Room No.- 434, Surgical Block, AIIMS,New Delhi

South
DELHI
110029
India 
Phone  09793184350  
Fax    
Email  subodh.08aiims@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Subodh Kumar 
Designation  ASSISTANT PROFESSOR 
Affiliation  AIIMS, New Delhi 
Address  Room No.- 434, Surgical Block, AIIMS,New Delhi

South
DELHI
110029
India 
Phone  09793184350  
Fax    
Email  subodh.08aiims@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Subodh Kumar 
Designation  ASSISTANT PROFESSOR 
Affiliation  AIIMS, New Delhi 
Address  Room No.- 434, Surgical Block, AIIMS,New Delhi

South
DELHI
110029
India 
Phone  09793184350  
Fax    
Email  subodh.08aiims@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Ansari Nagar, New Delhi - 110029 
 
Primary Sponsor  
Name  AIIMS 
Address  All India Institute of Medical Sciences Ansari Nagar, New Delhi - 110029 
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 SUBODH KUMAR  All India Institute of Medical Sciences  OPERATION THEATRE, Surgical Block, AIIMS,New Delhi
South
DELHI 
09793184350

subodh.08aiims@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE AIIMS NEW DELHI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J984||Other disorders of lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  110 degree rotation  110 anticlockwise rotation of left double lumen tube during left double lumen tube insertion. Approx time 1 min 
Comparator Agent  90 degree rotation  conventional 90 degree anticlockwise rotation of left double lumen tube 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients with age ≥ 18 years who are scheduled for thoracic surgery and requiring left sided DLT insertion for OLV. 
 
ExclusionCriteria 
Details  Anticipated difficult airway such as Malampati score ≥ 3
Previously tracheostomized patients
Previously operated case of cervical spine surgery
Presence of intratracheal or left intrabronchial mass
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the first success rate of left DLT placement into left main bronchus using 110 degree anticlockwise rotation with respect to conventional 90 degree rotation.  after DLT placement 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the true mean anatomic angle of left main bronchi with respect to trachea using three-dimensional CT scan (3D CT) in Indian population
To compare the incidence of carinal mucosal injury between the above two degree of rotation groups.
 
preoperative
after successfull placement of DLT 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   26/12/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Double lumen tubes (DLTs) appear to be a favourable method for the airway management during one lung ventilation (OLV) in thoracic surgery. Most commonly left sided DLT is used for OLV due to the anatomical advantage of left bronchus over right bronchus. Despite of the above fact it has been found that left sided DLT get misplaced to right main bronchus in about 4.2 % cases, especially in females and short stature patients.

Traditionally, it is thought that left and right bronchi divide in the same plane from trachea so left sided DLT to be rotated 90 degrees anticlockwise after bronchial tip of DLT has crossed the vocal cord to position bronchial lumen to left main bronchus. However, this conventional approach has been questioned by recent studies which suggest that left bronchus divide at an angle more than 90 degree with more posterior inclination. One study based on ct scan analysis of tracheobronchial tree had suggested that 110 degree anticlockwise rotation instead of conventional 90 degree anticlockwise rotation of DLT, whereas another study has advocated individualised rotation of DLT.[ Nevertheless, dimensions of  tracheobronchial tree vary in different races the findings of above studies  may not be reciprocated in Indian population. Hence,we plan this study  to determine the angle of anticlockwise rotation of left sided DLT for its optimal placement in indian population.

 
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