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CTRI Number  CTRI/2024/03/064685 [Registered on: 22/03/2024] Trial Registered Prospectively
Last Modified On: 15/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia
Process of Care Changes 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparison between non channeled blade with channeled blade of videolaryngoscope for securing the airway  
Scientific Title of Study   A randomized controlled, comparative study of intubation success rate between channeled Vs non channeled blade of Hugmed videolaryngoscope for orotracheal intubation. 
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 Priti Devalkar  
Designation  Associate professor  
Affiliation  Seth G S medical College Parel Mumbai  
Address  Department of Anesthesiology,1st floor,old building,Kem hospital, Acharya Donde Marg,parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9769934980  
Fax    
Email  devalkarpriti@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Priti Devalkar  
Designation  Associate professor  
Affiliation  Seth G S medical College Parel Mumbai  
Address  Department of Anesthesiology,1st floor,old building,Kem hospital, Acharya Donde Marg,parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9769934980  
Fax    
Email  devalkarpriti@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shivani Patil  
Designation  Junior Resident  
Affiliation  Seth G S medical College Parel Mumbai  
Address  Room no 20001,20th floor,ugpg girls wing hostel Kem hospital, Acharya Donde Marg,parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9082183341  
Fax    
Email  patilashivani1995@gmail.com  
 
Source of Monetary or Material Support  
1st floor, Department of Anaesthesiology, Seth GS Medical College and KEM Hospital, Parel, Mumbai. 
 
Primary Sponsor  
Name  Seth GSMC and KEMH 
Address  Acharya Donde Marg,Parel,Mumbai 400012 Maharashtra, India  
Type of Sponsor  Research institution and hospital 
 
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 Priti Devalkar   KEM Hospital Parel Mumbai   First floor, Department of Anaesthesiology,Seth Gs college and KEM Hospital,Acharya Donde Marg Parel Mumbai,
Mumbai
MAHARASHTRA 
9769934980

devalkarpriti@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC(III) RELATING TO BIOMEDICAL AND HEALTH RESEARCH SETH GS MEDICAL COLLEGE AND KEM HOSPITAL MUMBAI  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, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  A randomized controlled, comparative study of intubation success rate between between channeled Vs non channeled blade of Hugmed videolaryngoscope for orotracheal intubation   Comparison between the channeled and non channeled blade of Hugmed videolaryngoscope with respect to rate of successful intubation in elective surgery under General Anaesthesia This study to be done in time period within 15 months 
Comparator Agent  A randomized controlled, comparative study of intubation success rate between channeled Vs non channeled blade of Hugmed videolaryngoscope for orotracheal intubation.   The comparative agents are channeled and non channeled blade of Hugmed videolaryngoscope with respect to rate of successful intubation in elective surgery under General Anaesthesia. Duration of study is 15 month 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient of either sex of age group 18-60yr
2.Undergoing elective surgery under General anaesthesia with endotracheal intubation
3. ASA I and II 
 
ExclusionCriteria 
Details  1. Patient with difficult airway- mouth opening less than 2, restricted neck extension, neck swelling.
2. Emergency surgery
3.Increase risk of gastric content, regurgitation or aspiration. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison between the channeled and non-channeled blade of
Hugmed video laryngoscopes with respect to rate of successful
intubation in first attempt.
 
Comparison between the channeled and non-channeled blade of
Hugmed video laryngoscopes with respect to rate of successful
intubation in first attempt.
 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome includes:
1. Time-for-visualization of glottis
2. Time for intubation
3. Numbers of attempts
4. Percentage of Glottis Opening(POGO) score.
5. Ease of use of the video laryngoscopes.
7. Complications during intubation.
8. Difficulties during intubation.
9.Use of adjuncts .manipulation 
3 times will be measure in this study during orotracheal intubation:
1.Time from oral insertion of the videolaryngoscope until clear recognition of the glottis opening
on the videolaryngoscope.
2.Time from recognition of glottis vision to black line of endotracheal tube beyond vocal cord(T2).
3.Time from black line
of endotracheal tube beyond vocal cord till confirmation of intubation by auscultation and capnography(T3). 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/04/2024 
Date of Study Completion (India) 10/07/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
Laryngoscopy and endotracheal intubation play an important role in airway management for anaesthesiologists. Video laryngoscope may provide indirect glottis view without the need of alignment of oropharyngeal-laryngeal axis. It may reduce the number of failed intubations, particularly in patients with difficult airway. 
 This randomized comparative study was conducted in the general surgery operating theatre of a tertiary care center. Following approval from the institutional ethics committee and after obtaining written informed consent, a total of 80 patients scheduled for elective general surgical procedures requiring endotracheal intubation under general anaesthesia were enrolled. Participants fulfilling inclusion criteria were randomly assigned into two groups-patient intubated with channeled blade and patient intubated with non channeled of hugmed video laryngoscope—using computer-generated table. 
The primary objective of the study was comparison between the channeled and non-channeled blade of Hugmed video laryngoscopes with respect to rate of successful intubation in first attempt. Parameters assessed included time-for-visualization of glottis(T1), time till black line of ET tube beyond cord (T2), time till confirmation by capnography(T3), numbers of attempts for orotracheal intubation, POGO Score (percentage of glottis opening score), impingement and manipulation of ETT, Use of other adjuncts – bougie and complications due to intubation. 
 Demographics and airway characteristics were well matched for chnneled and non channeled group, with no statistically significant differences in age, gender, height, weight, ASA grade, mouth opening, neck movement, or Modified Mallampati Classification (all p > 0.05). This comparability between groups ensured that observed outcomes were not confounded by demographic or anatomical differences. 
The number of attempts required for successful intubation in all patients (100%) in the channeled group were successfully intubated on the first attempt, while 97.5% of the non channeled group were intubated on the first attempt, with only one patient (2.5%) requiring a second attempt. The difference between the groups was not statistically significant (p = 1.000), indicating that both techniques were comparably effective in achieving first-attempt intubation success. 
 The time to glottis visualization (T1) between the channeled group had a significantly longer mean T1 of 13.82 seconds, compared to 8.18 seconds in the non-channeled group. The difference was statistically significant (p < 0.0001), suggesting that glottis visualization was achieved more rapidly using the non-channeled technique. This implies better manoeuvrability or visualization efficiency with the non-channeled video laryngoscope blade. The time taken for the endotracheal tube (ETT) to pass beyond the vocal cords (T2) is the channeled group showed a significantly shorter mean time of 7.18 seconds, while the non channeled group required a substantially longer mean time of 16.80 seconds. This difference is highly statistically significant (p < 0.0001). These results indicate that the channeled video laryngoscope facilitated quicker advancement of the ETT beyond the vocal cords compared to the non-channeled blade. 
 The time for capnography confirmation (T3) showed channeled group demonstrated a significantly shorter mean time of 9.57 seconds, while the non-channeled group required a mean time of 11.65 seconds. The observed difference is highly statistically significant (p < 0.0001). This indicates that channeled blades allowed for faster confirmation of successful intubation via capnography, likely due to easier navigation and tube placement. 
 The POGO score for channeled group is 100.00%, indicating full visualization of the glottic opening in all cases. In contrast, the non-channeled group had a slightly lower mean POGO score of 96.88%, Although the difference approaches statistical significance (p = 0.0541), it 77 does not meet the conventional threshold of 0.05, suggesting a trend toward better glottic visualization with the channeled blade, but not conclusively so. 
In our study, intubation with the channeled blade required significantly fewer manipulations overall, with adjustments needed in 55% of cases compared to 12.5% in the non-channeled group (p = 0.00015) indicating smoother intubation with the channeled blade. Impingement over the epiglottis was more frequent with the non-channeled blade (20.0%) and absent in the channeled group (p = 0.0053). Withdrawal and redirection of the tube toward the midline occurred more often with the non-channeled blade (17.5% vs. 0%, p = 0.0647), while anticlockwise tube rotation was occasionally required in the channeled group (10%), without a significant difference between groups. The BURP manoeuvre was rarely needed in either group, with no significant difference. Overall, the channeled blade demonstrated smoother intubation with fewer corrective manoeuvres. 

 Bougie was used in 7.5% of non-channeled cases and in none of the channeled cases. The difference was not statistically significant (p = 0.239), indicating that adjunct usage was slightly higher in the non-channeled group, but the variation may be due to chance. Notably, sore throat occurred exclusively in 15% of non-channeled cases due to impingement of endotracheal tube, while lip bleeding was observed only in 10% of channeled cases due to bulky blade of channeled blade. The difference in overall complication rates was statistically significant (p = 0.0065), suggesting a meaningful variation in complication profiles between the two groups, potentially influenced by blade type. 
 Both the channeled and non-channeled video laryngoscope blades achieved a high first-attempt intubation success rate. The channeled video laryngoscope required less time for advancement of the endotracheal tube (EET) beyond the vocal cords, fewer optimization maneuvers, and was associated with a lower incidence of complications, highlighting its practical advantages in routine airway management. The non-channeled blade offered faster glottic visualization, had a smaller blade size, and aligned with certain operator preferences. 78 However, its limitations included a longer time for the endotracheal tube to pass beyond the cords, and a greater need for additional manoeuvres to achieve successful intubation and complication during intubation.
 
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