| 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
|
|
|
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
|
|
|
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. |