| CTRI Number |
CTRI/2025/12/098852 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study on the ease of inserting an airway tube using Millers blade and video assisted scope in adult patients under a simulated difficult airway. |
|
Scientific Title of Study
|
Comparative study of ease of endotracheal intubation using Millers blade by para glossal approach and C MAC video laryngoscope in adult patients with simulated difficult airway : a one year randomised clinical 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 |
Dr Sushma Tumati |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesilogy , Jawaharlal Nehru Medical college, Nehru nagar.
Belgaum.
Belgaum
KARNATAKA
590010
India |
| Phone |
9964140012 |
| Fax |
|
| Email |
sushmatumati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MANJUNATH C PATIL |
| Designation |
PROFESSOR |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical college.
Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9743110637 |
| Fax |
|
| Email |
mcpatil52@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MANJUNATH C PATIL |
| Designation |
PROFESSOR |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical college.
Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9743110637 |
| Fax |
|
| Email |
mcpatil52@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of anaesthesiology, Jawaharlal Nehru medical college ,Nehru nagar , Belgaum, Karnataka 590010 |
|
|
Primary Sponsor
|
| Name |
Dr.Sushma Tumati |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru medical college,
Nehru nagar, Belgaum
Karnataka
590010 |
| 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 Sushma Tumati |
KLEs DR PRABHAKAR KORE HOSPITAL AND MEDICAL RESEARCH CENTRE BELAGAVI |
Anaesthesia department, Nehru Nagar Belagavi, Karnataka 590010
Belgaum
KARNATAKA |
9964140012
sushmatumati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTEE JAWAHARLAL BEHRU MEDICAL COLLEGE |
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 |
| Intervention |
GROUP M is millers blade laryngoscope |
Laryngoscopy will be done using Millers blade of appropriate size via paraglossal approach. |
| Intervention |
GROUP V is video laryngoscope blade type is c mac |
Laryngoscopy will be done using C MAC video laryngoscope blade of appropriate size. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
1. Adult patients of either sex
2.Age 18 to 65 years
3.ASA physical status 1 and 2
4.No history of difficult airway but able to undergo simulated airway condition, Schedule for elective surgeries under general endotracheal Anaesthesia |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
1. History of difficult intubation
2.High aspiration risk
3. Anatomical abnormalities |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
assessing the ease of endotracheal intubation with
airway difficulty score
intubation difficulty score |
during laryngoscopy after administration of anaesthetic induction agent |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
First attempt intubation success rate
Time taken to intubation
Number of attempts needed |
during laryngoscopy after administration of anaesthetic induction agent |
|
|
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)
|
10/01/2026 |
| 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
|
Endotracheal intubation is the most common definitive airway during general anaesthesia. Airway management failure can cause serious harm making laryngoscopy essential for safe intubation. Video laryngoscope like c mac enhance glottic view while millers blade with paraglossal approach also improves visualization in difficult airway. This study compares both techniques to determine which provides easier intubation in simulated difficult airway conditions. |