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CTRI Number  CTRI/2024/09/073736 [Registered on: 10/09/2024] Trial Registered Prospectively
Last Modified On: 23/02/2026
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   To study how easy it is to insert a breathing tube (Endotracheal tube) and how well we can see the breathing tract using two different tools 
Scientific Title of Study   Comparison of Macintosh blade vs Miller blade for glottic view and ease of intubation in adults.  
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 Prerana Nirav Shah 
Designation  Professor 
Affiliation  Seth Gordhandas Sunderdas Medical College King Edward Memorial Hospital  
Address  Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  9869117027  
Fax    
Email  pps@kem.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vishwanath Patil 
Designation  Resident 
Affiliation  Seth Gordhandas Sunderdas Medical College King Edward Memorial Hospital  
Address  Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  7026305618  
Fax    
Email  patilvishwanath43@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vishwanath Patil 
Designation  Resident 
Affiliation  Seth Gordhandas Sunderdas Medical College King Edward Memorial Hospital  
Address  Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  7026305618  
Fax    
Email  patilvishwanath43@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India  
 
Primary Sponsor  
Name  Seth Gordhandas Sunderdas Medical College King Edward Memorial Hospital  
Address  Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vishwanath Patil  Seth Gordhandas Sunderdas Medical College King Edward Memorial Hospital   Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India
Mumbai
MAHARASHTRA 
7026305618

patilvishwanath43@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe (IEC)-III) Relating to Biomedical and Health Research (BHR)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Macintosh Blade  Modified Cormack-Lehane grading, POGO Score, Intubation difficulty scale All shall be noted once during laryngoscopy 
Intervention  Miller Blade  Modified Cormack-Lehane grading, POGO Score, Intubation difficulty scale All shall be noted once during laryngoscopy 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age 18-65 yrs.
ASA I, II & III patients.
Mallampati class I,II and III
Elective surgical procedures requiring general anaesthesia with endotracheal intubation
 
 
ExclusionCriteria 
Details  Patients who refuse to participate in the study.
BMI more than 35 Kg/m²
Mouth opening less than 4cms
Pregnant patients
Patients who are already intubated.
Patients needing rapid sequence intubation.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess and compare the glottic view using modified Cormack-Lehane grading and POGO (Percentage Of Glottic Opening) score.   preoperative 
 
Secondary Outcome  
Outcome  TimePoints 
To grade the ease of intubation using intubation difficulty scale.
To assess haemodynamic response, duration needed for intubation.
Satisfaction of the anaesthesiologist. 
Baseline, at the time of laryngoscopy and post intubation- at 1 min, 5 min and 10 min. 
 
Target Sample Size   Total Sample Size="118"
Sample Size from India="118" 
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)   13/09/2024 
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  

Tracheal intubation is the gold standard for airway management because it secures a definitive airway, protects against gastric aspiration, and allows for high-pressure positive ventilation. The most common technique for tracheal intubation is direct laryngoscopy, which involves visualising glottis with a laryngoscope and inserting the endotracheal tube into the trachea.

Various direct laryngoscopes have been developed, but the Macintosh and Miller blades remain the most widely used. Macintosh blade is used to displace the epiglottis out of the line of sight by placement of the distal tip in the vallecula and tensing of the glossoepiglottic ligament. The Miller blade reveals the glottis by compressing the epiglottis against the base of the tongue.The Miller blade minimizes displacement of oral structures and reduces the risk of soft tissue trauma, whereas the Macintosh blade is easier to operate. The choice between these blades is influenced by factors such as the laryngoscopist’s preference and experience.

There exists a certain group of patients with flaccid epiglottis which cannot be predicted with routine bedside examinations. Elevation of such epiglottis with a  Macintosh laryngoscope does not provide a better view of the glottis.

This study is planned to compare the glottic view, effectiveness and ease of intubation with Macintosh blade and Miller blade during laryngoscopy. The study will be designed as a randomised controlled trial with 118 patients as subjects. 59 of these patients will be intubated using Macintosh Blade and 59 will be intubated with Miller’s Blade.

The glottic view will be graded by Cormack-Lehane grading and percentage of glottic opening score and the ease of intubation will be assessed with the help of intubation difficulty score. Additionally the haemodynamic response, duration needed for intubation and the satisfaction of the anaesthesiologist will be studied.

 
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