| CTRI Number |
CTRI/2026/02/103131 [Registered on: 05/02/2026] Trial Registered Prospectively |
| Last Modified On: |
20/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Two Techniques of Airway Tube Placement in Patients undergoing Thoracic Surgery |
|
Scientific Title of Study
|
Direct Laryngoscopy Versus Video Laryngoscopy for Ease of Double Lumen Tube Insertion in Thoracic Surgery: A Randomized Controlled Trial |
| Trial Acronym |
DL-VL DLT Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amita Jansari |
| Designation |
Assistant Professor |
| Affiliation |
Gujarat Cancer and Research Institute |
| Address |
Department of Anesthesia, Fifth floor, C wing, GCRI, Civil hospital, Asarwa, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
07922688283 |
| Fax |
|
| Email |
amita.jansari@gcriindia.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amita Jansari |
| Designation |
Assistant Professor |
| Affiliation |
Gujarat Cancer and Research Institute |
| Address |
Department of Anesthesia, Fifth floor, C wing, GCRI, Civil hospital, Asarwa, Ahmedabad
GUJARAT
380016
India |
| Phone |
07922688283 |
| Fax |
|
| Email |
amita.jansari@gcriindia.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amita Jansari |
| Designation |
Assistant Professor |
| Affiliation |
Gujarat Cancer and Research Institute |
| Address |
Department of Anesthesia, Fifth floor, C wing, GCRI, Civil hospital, Asarwa, Ahmedabad
GUJARAT
380016
India |
| Phone |
07922688283 |
| Fax |
|
| Email |
amita.jansari@gcriindia.org |
|
|
Source of Monetary or Material Support
|
| Tertiary Care Centre named Gujarat Cancer And Research Institute, Ahmedabad |
|
|
Primary Sponsor
|
| Name |
GCRI |
| Address |
Gujarat Cancer And Research Institute, Civil Hospital campus, Asarwa, Ahmedabad |
| Type of Sponsor |
Government medical college |
|
|
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 Amita Jansari |
Gujarat Cancer and Research Institute |
Dept. of Anesthesiology and Oncosurgery, 5th Floor, GCRI,Civil Hospital Campus, Asarwa, Ahmedabad.
Ahmadabad
GUJARAT |
9879778701
amita.jansari@gcriindia.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GCRI/GCS ETHICS COMMITTEE-BHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Direct laryngoscopy guided double lumen tube insertion |
Double lumen endotracheal tube insertion performed using conventional direct laryngoscopy after induction of general anaesthesia |
| Intervention |
Video Laryngoscope guided double lumen tube insertion |
Double lumen endotracheal tube insertion performed using a video laryngoscope after induction of general anaethesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) ASA physical status I-III
2) Mallampatti class I-II
3) Elective thoracic surgery requiring double lumen tube
4) written informed consent |
|
| ExclusionCriteria |
| Details |
1) Anticipated difficult airway
2) BMI more than 30
3) Emergency surgery
4) Patient refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time required for double lumen tube insertion |
time(in seconds) measured from insertion of laryngoscope blade between the incisors until confirmation of successful double lumen tube placement by capnography |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Time taken for successful intubation (seconds)
2) First attempt success rate
3) Cormack- Lehane glottic view
4) Requirement of external laryngeal manipulation
5) Airway trauma & coplications |
intubation time-period from insertion of scope to etco2 confirmation |
|
Target Sample Size
Modification(s)
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
16/02/2026 |
| 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)
Modification(s)
|
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
Modification(s)
|
This is prospective, randomized, comparative study to study esae of double lumen tube insertion with conventional direct laryngoscopy versus video laryngoscopy in adult patients undergoing elective thoracic surgery. Primary objective of the study is to compare the ease of double lumen tube insertion between conventional laryngoscopy and video laryngoscope. secondary objectives of the study are to compare the time taken for successful intubation, to compare the first attempt success rate, to assess glottic visualization (Cormack-Lehane grade), External laryngeal manipulation, to evaluate airway trauma or complications (sore throat, hoarseness, bleeding) |