| 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
|
|
|
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
|
|
|
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. |