| CTRI Number |
CTRI/2026/02/104809 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Are airway devices sized for the western population suitable for Indians? |
|
Scientific Title of Study
|
Tracheobronchial tree dimensions in Indian adults in the context of lung isolation techniques: An observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANJU LETHA MOHAN |
| Designation |
DNB Trainee |
| Affiliation |
Medanta The Medicity |
| Address |
Anaesthesia and Critical care department
Medanta The Medicity
Gurgaon
HARYANA
122001
India |
| Phone |
8586934801 |
| Fax |
|
| Email |
anjulmohan999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Anand Sharma |
| Designation |
Director |
| Affiliation |
MEDANTA THE MEDICITY |
| Address |
Anaesthesia and Critical Care
Medanata The Medicity
HARYANA
122018
India |
| Phone |
9910267371 |
| Fax |
|
| Email |
seldonterm2@yahoo.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
Anju Letha Mohan |
| Designation |
DNB Trainee |
| Affiliation |
Medanta The Medicity |
| Address |
Anaesthesia and Critical care department
Medanta The Medicity
HARYANA
122018
India |
| Phone |
8586934801 |
| Fax |
|
| Email |
anjulmohan999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medanta the medicity
CH Baktawar Singh road,
Medicity
Islampur Colony
Sector 38
Gurugram
Haryana 122018 |
|
|
Primary Sponsor
|
| Name |
medanta the medicity |
| Address |
CH Baktawar Singh Rd, Medicity, Islampur Colony, Sector 38, Gurugram, Haryana 122018 |
| 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 |
| ANJU LETHA MOHAN |
MEDANTA THE MEDICITY |
Radiology Department
Gurgaon
HARYANA |
8586934801
anjulmohan999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MEDANTA INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Indian origin |
|
| ExclusionCriteria |
| Details |
1.Obvious Distortion in the morphology of the tracheobronchial tree
2.MDCT scans done outside of Medanta The medicity, Gurgaon. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Profiling of airway dimensions nof the tracheobronchial tree among the Indian population and determination of the best fitting double lumen tube. |
At 10 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Correlation of airway dimensions separately for male/female & height categories
2. Identification of the best fitting double lumen tube size with height in males/females |
At 10 months |
|
|
Target Sample Size
|
Total Sample Size="360"
Sample Size from India="360"
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
|
N/A |
|
Date of First Enrollment (India)
|
09/03/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Lung isolation and one lung ventilation are used to facilitate surgery on the lungs, thoracic, aorta, and thoracic spine, oesophagus, and during minimally invasive cardiac surgery. it is used to prevent contamination of the healthy lung by blood or infected material. Lung isolation is achieved with a double-lumen tracheal tube, a bronchial blocker, or, in an emergency, by advancing a single-lumen tracheal tube into the main bronchus. Appropriate dimensions of these devices are essential for adequate lung ventilation without complications. The conventional recommendation is to insert the largest possible dlt, taking into account the patient’s height and gender. However, the dimensions of currently available commercial devices are based on Western anatomy. Indians differ in stature from other ethnic groups. This often leads to problems in lung isolation with minimal trauma. We hope to fill the lacunae by using multiple-detector computed tomography of chest measurements in Indian adults to select the appropriate size of the currently available lung isolation devices. |