| 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
|
|
|
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
|
|
|
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. |