| CTRI Number |
CTRI/2025/03/083445 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical trial to compare three different laryngoscopes for intubation in patients with difficult airway |
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Scientific Title of Study
|
Comparison Of Mcgrath Mac Video Laryngoscope, Channeled King Vision Video Laryngoscope And Macintosh Direct Laryngoscope For Orotracheal Intubation In Patients With Anticipated Difficult Airway- A Randomized Clinical Trial
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| Trial Acronym |
NIL |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SARA BATOOL |
| Designation |
RESIDENT, MD ANAESTHESIA |
| Affiliation |
Hamdard Institute Of Medical Sciences And Research, New Delhi |
| Address |
Department of Anesthesiology, Operation Theatre, Block B, New Hospital Building, Hamdard Institute of Medical Sciences and Research, Hamdard Nagar, New Delhi
New Delhi
DELHI
110062
India |
| Phone |
7985372791 |
| Fax |
|
| Email |
saarabatool6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ABRAQ ASMA RIYAZ |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Hamdard Institute of Medical Sciences And Reseach, New Delhi |
| Address |
Department of Anesthesiology, Operation Theatre, Block B, New Hospital Building, Hamdard Institute of Medical Sciences and Research, Hamdard Nagar, New Delhi
New Delhi
DELHI
110062
India |
| Phone |
9149646151 |
| Fax |
|
| Email |
abraq11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ABRAQ ASMA RIYAZ |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Hamdard Institute of Medical Sciences and Research, New Delhi |
| Address |
Department of Anesthesiology, Operation Theatre, Block B, New Hospital Building, Hamdard Institute of Medical Sciences and Research, Hamdard Nagar, New Delhi
New Delhi
DELHI
110062
India |
| Phone |
9149646151 |
| Fax |
|
| Email |
abraq11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, Operation Theatre, Block B, New Hospital Building, Hamdard Institute of Medical Sciences and Research, Hamdard Nagar, New Delhi |
|
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Primary Sponsor
|
| Name |
Hamdard Institute of Medical Sciences and Research |
| Address |
Hamdard Institute of Medical Sciences and Research, Hamdard Nagar, New Delhi, 110062 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SARA BATOOL |
Hamdard Institute of Medical Sciences and Research |
Department of Anesthesiology, Operation Theatre, Block B, New Hospital Building, Hamdard Institute of Medical Sciences and Research, Hamdard Nagar, New Delhi
New Delhi
DELHI |
7985372791
saarabatool6@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC HIMSR |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Channeled King vision videolaryngoscope |
a type of medical device used to visualize the airway during intubation, where the blade has an integrated channel built-in to guide the endotracheal tube directly into the trachea, making it easier to insert the tube, especially in difficult airway situation |
| Intervention |
MacGrath Mac videolaryngoscope |
MacGrath Mac is a battery operated, portable videolaryngoscope with different size of blades used to indirectly visualise the glottis on the screen of the device which aids intubation with desired endotracheal tube |
| Comparator Agent |
Macintosh direct laryngoscope |
The Macintosh laryngoscope has a curved blade which allows exposure of the larynx by positioning the tip in the vallecula, anterior to the epiglottis, lifting it out of view and hence facilitating endotracheal intubation |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with American society of anaesthesiology physical status 1 and 2, planned for Elective surgery under general anaesthesia, requiring orotracheal intubation with Anticipated difficult airway and TAS more than 6 |
|
| ExclusionCriteria |
| Details |
Less than 3 finger breadth mouth opening, Pregnancy, Vocal Cord Pathology, laryngeal or pharyngeal friable mass, Refusal to participate
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
To Compare First Pass Intubation Success Rate using McGrath VL , King Vision VL And Macintosh DL in surgical patients with anticipated difficult airway and to compare the time to intubate in the three groups.
|
1 day |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the ease of intubation in three groups by using Intubation Difficulty Scoring and to compare the hemodynamic changes associated with laryngoscopy in each group and to study complications related to laryngoscopy like trauma to lips, teeth, tongue, oropharyngeal bleeding, Fogging, desaturation, post operative hoarseness and sore throat in each group |
1 day |
|
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Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
21/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
21/04/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [saarabatool6@gmail.com].
- For how long will this data be available start date provided 01-11-2026 and end date provided 31-12-2070?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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Brief Summary
|
The study titled -Comparison of McGrath MAC Video Laryngoscope, Channeled King Vision Video Laryngoscope, and Macintosh Direct Laryngoscope for Orotracheal Intubation in Patients with Anticipated Difficult Airway: A Randomized Clinical Trial aims to evaluate the effectiveness of different laryngoscopic techniques in patients with anticipated difficult airways.
Background:
Effective airway management is critical in anesthesia practice. The Macintosh direct laryngoscope (DL) is traditionally the first choice, but video laryngoscopes (VL), such as the McGrath MAC and King Vision, are gaining popularity due to improved glottic visualization and ease of intubation. However, their comparative efficacy in anticipated difficult airways remains unclear.
Objectives:
Primary: Compare first-pass intubation success rates and intubation time among the three devices.
Secondary: Assess ease of intubation using the Intubation Difficulty Score (IDS), hemodynamic changes, and complications such as trauma, desaturation, and post-operative sore throat.
Methods:
A single-blind, randomized controlled trial with three parallel arms.
135 adult patients (45 per group) undergoing elective surgery under general anesthesia with an anticipated difficult airway (Total Airway Score >6) will be enrolled.
Patients will be randomly assigned to one of three groups: Group MM: McGrath MAC VL
Group KV: Channeled King Vision VL
Group DL: Macintosh DL
Standardized anesthesia induction and intubation procedures will be followed.
Data on intubation success, time to intubation, and complications will be recorded.
Expected Outcomes:
The study hypothesizes that the McGrath MAC VL will have a higher first-pass success rate and shorter intubation time compared to the King Vision VL and Macintosh DL. Findings could influence the choice of laryngoscopy devices in difficult airway management.
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