| CTRI Number |
CTRI/2026/04/108349 [Registered on: 13/04/2026] Trial Registered Prospectively |
| Last Modified On: |
06/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study in Adult Patients Undergoing General Anaesthesia to Compare Two Video Laryngoscopes for Successful Placement of a Breathing Tube |
|
Scientific Title of Study
|
Comparison of BPL video laryngoscope vs TAS-scope video laryngoscope (indigenously assembled for intubation in adult): A prospective, randomized, comparative, clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tanuj H Sankhala |
| Designation |
FIRST YEAR RESIDENT DOCTOR |
| Affiliation |
Shantabaa Medical College And Genral Hospital, Amreli |
| Address |
DEPARTMENT OF ANAESTHESIA,
Shantabaa Medical College And Genral Hospital,
Amreli,
GUJARAT
Amreli
GUJARAT
365601
India |
| Phone |
9427115611 |
| Fax |
|
| Email |
drtanujhsankhala1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. RAVIKUMAR M PARMAR |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT |
| Affiliation |
Shantabaa Medical College And General Hospital, Amreli |
| Address |
DEPARTMENT OF ANAESTHESIA,
Shantabaa Medical College And Genral Hospital,
Amreli,
GUJARAT
Amreli
GUJARAT
365601
India |
| Phone |
9099097807 |
| Fax |
|
| Email |
ravirajparmar1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR. RAVIKUMAR M PARMAR |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT |
| Affiliation |
Shantabaa Medical College And Genral Hospital, Amreli |
| Address |
DEPARTMENT OF ANAESTHESIA,
Shantabaa Medical College And Genral Hospital,
Amreli,
GUJARAT
Amreli
GUJARAT
365601
India |
| Phone |
9099097807 |
| Fax |
|
| Email |
ravirajparmar1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shantabaa medical college and general hospital, amreli |
|
|
Primary Sponsor
|
| Name |
Shantabaa Medical College |
| Address |
Shantabaa Medical College And General Hospital, Amreli |
| Type of Sponsor |
Private 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 Ravikumar M Parmar |
Shantabaa medical college and general hospital |
Operation theatre, at new and old building
Amreli
GUJARAT |
9099097807
ravirajparmar1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SHANTABAA MEDICAL COLLEGE & GENERAL HOSPITAL, AMRELI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bpl videolaryngoscope |
Type: Video laryngoscope
Use: Endotracheal intubation
Feature: Camera-based blade with screen
Advantage: Better glottic view, less neck movement
Indication: Difficult airway |
| Comparator Agent |
TAS Scope videolaryngoscope |
The TAS Scope videolaryngoscope is an indigenously assembled video assisted airway device designed to facilitate endotracheal intubation by providing an indirect, camera based view of the glottis on a display screen. It consists of a laryngoscope blade fitted with a video camera and light source, allowing improved visualization of airway structures with minimal lifting force. The device is used in patients undergoing general anaesthesia to assist in safe and effective placement of the endotracheal tube under controlled operating room conditions. |
| Intervention |
videolaryngoscope |
This study evaluates the use of a videolaryngoscope for placing a breathing tube in adult patients undergoing surgery under general anaesthesia. The videolaryngoscope is a device that provides a clear view of the airway using a camera, which may improve the ease and safety of intubation. The study compares two types of videolaryngoscopes in patients scheduled for elective and non emergency procedures. Participants will be randomly assigned to one of the two devices. The study will measure the time taken to insert the breathing tube number of attempts required changes in heart rate and blood pressure and any airway related complications. The findings aim to help doctors choose safe and effective airway devices for routine surgical care. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
66.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2.
Mallampati grade 1 and 2.
Mouth opening more than 2 finger breath on preanaesthetic assessment.
Elective and non emergency surgery requiring GA. |
|
| ExclusionCriteria |
| Details |
Refusal.
Morbid obesity (BMI more than 35 kg/meter square).
Coagulopathy or history of anticoagulant use.
Pathology of neck, airway or alimentary tract.
Pregnant Patients.
Patient posted for emergency surgery. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare effectiveness of TAS scope videolaryngoscope and BPL videolaryngoscope in terms of:-
1) Glottic exposure time. (T1)
2) Tube insertion time. (T2)
3) Total duration of intubation. (T1+T2)
4) Number of attempts. (maximum 3)
5) External laryngeal manipulation |
(T1)- Measured during the laryngoscopy phase, before introduction of the endotracheal tube
(T2)- Tube Insertion Time (T2)
(T1 + T2)- Measured from start of laryngoscopy to confirmation of successful tube placement
Number of Attempts (Maximum 3)- Recorded per intubation episode until successful intubation or completion of a maximum of three attempts
External Laryngeal Manipulation (ELM)- Assessed during the glottic exposure phase (T1) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess hemodynamic response in terms of heart rate, mean arterial blood
pressure(MAP) & SpO2 during periprocedure time.
To assess complications in terms of Airway trauma (lips, tooth, tongue) |
Baseline
Just after Intubation
3min post intubation
5min post intubation |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
27/04/2026 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drtanujhsankhala1@gmail.com].
- For how long will this data be available start date provided 16-02-2026 and end date provided 29-02-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a prospective randomized comparative clinical trial designed to compare the effectiveness of BPL Video Laryngoscope and TAS Video Laryngoscope for endotracheal intubation in adult patients undergoing elective and non emergency surgeries under general anaesthesia. One hundred patients aged sixteen to sixty years with ASA physical status one and two will be randomly allocated into two equal groups. Primary outcomes include glottic exposure time tube insertion time total intubation time number of attempts and need for external laryngeal manipulation. Secondary outcomes include hemodynamic changes and airway related complications. The study aims to evaluate the safety and clinical utility of an indigenously assembled video laryngoscope compared to a commercially available device. |