| CTRI Number |
CTRI/2026/03/105446 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study comparing two methods of inserting a double lumen tube for one lung ventilation |
|
Scientific Title of Study
|
Comparative study of standard versus magills curve modified technique of double lumen tube insertion required for one lung ventilation |
| 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 Nivya M |
| Designation |
Post graduate |
| Affiliation |
Madurai medical college |
| Address |
No 121,Institute of Anaesthesiology,Anaesthesia division,Government Rajaji hospital and Madurai medical college,Madurai
Madurai
TAMIL NADU
625020
India |
| Phone |
7708527044 |
| Fax |
|
| Email |
nivyashan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shanmuga Sundaram MD |
| Designation |
Professor Institute of Anaesthesiology Madurai medical college |
| Affiliation |
Madurai medical college |
| Address |
No 121,Institute of Anaesthesiology,Anaesthesia division,Government Rajaji hospital and Madurai medical college,Madurai
Madurai
TAMIL NADU
625020
India |
| Phone |
9842106367 |
| Fax |
|
| Email |
sundarmsvs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nivya M |
| Designation |
Post graduate |
| Affiliation |
Madurai medical college |
| Address |
No 121,Institute of Anaesthesiology,Anaesthesia division,Government Rajaji hospital and Madurai medical college,Madurai
Madurai
TAMIL NADU
625020
India |
| Phone |
7708527044 |
| Fax |
|
| Email |
nivyashan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Institute of Anaesthesiology,Government Rajaji Hospital and Madurai medical college |
| Address |
203/2 PNK Colony, Anna nagar,Maharaja nagar post,Tirunelveli 627011 |
| Type of Sponsor |
Other [Self] |
|
|
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 Nivya M |
Government Rajaji hospital and Madurai medical college |
JICA Complex,4th floor,CTVS OT, Government Rajaji hospital
Madurai
TAMIL NADU |
7708527044
nivyashan@gmail.com |
|
|
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 |
(1) ICD-10 Condition: J984||Other disorders of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Magills curve modified double lumen tube insertion technique |
The double lumen tube will be modified as the preformed magills curve using a stylet and inserted for one lung ventilation |
| Comparator Agent |
Standard double lumen tube insertion technique |
The double lumen will be inserted using coventional standard technique without modification of the tube |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA 1 and 2
2.Elective surgeries requiring one lung ventilation |
|
| ExclusionCriteria |
| Details |
1.ASA 3 and 4
2.Age less than 18 years and more than 65 years
3.Difficult airway
4.Edentolous
5.Patients with oropharyngeal carcinomas and post oral surgery
6.Patient received radiotherapy or those with cervical spine injury |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To elicit the time taken for intubation and number of attempts required
To find out the need of optimal external laryngeal manipulations and number of attempts required |
At the time of Intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the hemodynamic response while intubation
To analyse any complications during intubation
To compare the variables collected with respect to age,group,gender and neck circumference |
At the time of intubation |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
16/03/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
A double lumen tube (DLT) is a specialized endotracheal tube designed with two separate lumens to allow independent ventilation of each lung which is commonly used in cardiothoracic surgeries. This study compares the standard technique and the preformed magill’s curve modified technique for Double lumen tube insertion required for one lung ventilation
Comparison is based on the: 1.Time taken for intubation and number of attempts required 2.Need of external laryngeal manipulations 3.Hemodynamic response while intubation 4.Complications during intubation 5.The variables collected with respect to age,gender,group and neck circumference |