| CTRI Number |
CTRI/2026/01/100819 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
10/01/2026 |
| 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 clinical trial to study the effect of two video instruments for introducing a tube in the wind pipe of patients undergoing anaesthesia |
|
Scientific Title of Study
|
Comparative evaluation of Video laryngoscope and The Anaesthetist Society Scope (TAS scope) for intubation in patients with anticipated difficult airway: a prospective, randomised, controlled, double blind 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 |
Kishan Kumar |
| Designation |
Senior Consultant |
| Affiliation |
Manipal Hospital Whitefield |
| Address |
First floor, Department of Anaesthesia, Manipal Hospital Whitefield, ITPL main road, Krishnarajapura, Bangalore.
Bangalore
KARNATAKA
560067
India |
| Phone |
6361571292 |
| Fax |
|
| Email |
drkumarkishan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Muni Venkatesh |
| Designation |
DNB resident |
| Affiliation |
Manipal Hospital Whitefield |
| Address |
First floor, Department of Anaesthesia, Manipal Hospital Whitefield, ITPL main road, Krishnarajapura, Bangalore.
Bangalore
KARNATAKA
560067
India |
| Phone |
8121313424 |
| Fax |
|
| Email |
munivenkateshg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kishan Kumar |
| Designation |
Senior Consultant |
| Affiliation |
Manipal Hospital Whitefield |
| Address |
First floor, Department of Anaesthesia, Manipal Hospital Whitefield, ITPL main road, Krishnarajapura, Bangalore.
Bangalore
KARNATAKA
560067
India |
| Phone |
6361571292 |
| Fax |
|
| Email |
drkumarkishan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal Hospital Whitefield, ITPL main road, Krishnarajapura, Bangalore, India. Pincode - 560067.
|
|
|
Primary Sponsor
|
| Name |
Manipal Hospital Whitefield |
| Address |
Manipal Hospital 98, HAL old airport road, Kodihalli, Bangalore, India. Pinched - 560017. |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Kishan Kumar |
Manipal Hospital Whitefield |
First floor, Department of Anaesthesia, Manipal Hospital Whitefield, ITPL main road, Krishnarajapura, Bangalore, India. Pinched - 560067.
Bangalore
KARNATAKA |
6361571292
drkumarkishan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICAL COMMITTEE OF MANIPAL HOSPITALS |
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 |
The Anaesthesia Society scope (TAS scope) |
Following preoxygenation with 100% oxygen for 3 min, patients will be induced with injection propofol 1.5–2 mg/kg IV and after confirming bag and mask ventilation, injection rocuronium 1.2 mg/kg IV will be administered. After ventilation for 90 s, patients will be placed in sniffing position, and laryngoscopy will be performed using the TAS scope for a duration of maximum 2 minutes. |
| Intervention |
Video laryngoscope |
Following preoxygenation with 100% oxygen for 3 min, patients will be induced with injection propofol 1.5–2 mg/kg IV and after confirming bag and mask ventilation, injection rocuronium 1.2 mg/kg IV will be administered. After ventilation for 90 s, patients will be placed in sniffing position, and laryngoscopy will be performed using the Video laryngoscope for a duration of maximum 2 minutes. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to the American Society of Anaesthesiologists (ASA) physical status I, II and III
Patients having a Mallampati grade of III or IV or patients requiring cervical stabilization.
Patients undergoing elective surgery under general anesthesia with orotracheal intubation |
|
| ExclusionCriteria |
| Details |
Patient refusal for the study
Patients undergoing emergency surgery
Patients with full stomach
Pregnant patients
Patients with facio-maxillary trauma |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the laryngoscopic view obtained by TAS scope and video laryngoscope (VLS) using Cormack Lehane grade in patients categorized as Mallampati grade III or IV or patients requiring cervical stabilization. |
After laryngoscopy (3 minutes after induction) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the laryngoscopic view obtained by TAS scope and video laryngoscope (VLS) using percentage of glottic opening score (POGO score) in patients categorized as Mallampati grade III or IV or patients requiring cervical stabili |
After laryngoscopy (3 minutes after induction) |
| To compare the hemodynamic response to laryngoscopy with TAS scope and video laryngoscope (VLS) in patients categorized as Mallampati grade III or IV or patients requiring cervical stabilization. |
After laryngoscopy (3 minutes after induction) |
| To compare the time for laryngoscopy with TAS scope and video laryngoscope (VLS) in patients categorized as Mallampati grade III or IV or patients requiring cervical stabilization. |
After laryngoscopy (3 minutes after induction) |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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)
|
30/01/2026 |
| 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) |
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
|
The present study aims to compare Video laryngoscope group and TAS scope group regarding ease of intubation in patients with an anticipated difficult airway. The primary aim of our study is to compare Cormack Lehane score in all patients using Video laryngoscope and TAS scope. Secondary objectives include percentage of glottic opening score (POGO), hemodynamic changes during laryngoscopy and airway trauma. |