| CTRI Number |
CTRI/2025/02/081074 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study comparing Kingvision video laryngoscope, Airtraq video laryngoscope and Macintosh laryngoscope for orotracheal intubation in adult patients posted for elective surgeries under general anesthesia to observe the ease of intubation based IDS score |
|
Scientific Title of Study
|
A COMPARATIVE RANDOMIZED CONTROLLED STUDY OF KINGVISION VIDEO LARYNGOSCOPE, AIRTRAQ VIDEO LARYNGOSCOPE AND MACINTOSH LARYNGOSCOPE |
| Trial Acronym |
NIl |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kethireddy koushik |
| Designation |
postgraduate |
| Affiliation |
Government Medical College, Kadapa |
| Address |
Room no: 200,
Department of Anaesthesiology,
Government medical college,
putlampalli, kadapa
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
09676122878 |
| Fax |
|
| Email |
kousikmbbs489@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
S.Raghavendra prasad |
| Designation |
Associate professor |
| Affiliation |
Government Medical College, Kadapa |
| Address |
Room no: 200,
Department of Anaesthesiology,
Government medical college,
putlampalli, kadapa
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
09676122878 |
| Fax |
|
| Email |
saya_knl@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Kethireddy koushik |
| Designation |
postgraduate |
| Affiliation |
Government Medical College, Kadapa |
| Address |
Room no: 200,
Department of Anaesthesiology,
Government medical college,
putlampalli, kadapa
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
09676122878 |
| Fax |
|
| Email |
kousikmbbs489@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,
Government medical college,
putlampalli, kadapa - 516002 |
|
|
Primary Sponsor
|
| Name |
K Koushik |
| Address |
Postgraduate
Department of Anaesthesiology
GMC, kadapa |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Kethireddy Koushik |
Government Medical College |
Room no: 200,
Department of Anaesthesiology,
Government medical college,
putlampalli, kadapa
Cuddapah
ANDHRA PRADESH |
09676122878
kousikmbbs489@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics comittee, government medical college, kadapa |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: X||New Technology, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Airtraq video laryngoscope |
Ease of orotracheal intubation observed using IDS score |
| Comparator Agent |
Kingvision video laryngoscope |
Ease of orotracheal intubation observed using IDS score |
| Comparator Agent |
Macintosh laryngoscope |
Ease of orotracheal intubation observed using IDS score |
| Intervention |
Orotracheal intubation |
In adult patients scheduled for elective surgeries under general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I and II
MPG Grade I and II
BMI less than 25 kg/sq.m
Patients posted for elective surgeries under GA |
|
| ExclusionCriteria |
| Details |
Patients with cervical spine injury
Patients with anticipated difficult intubation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ease of Intubation using IDS score |
From insertion of laryngoscope beyond incisor teeth until successful intubation confirmed on capnography |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of Intubation |
From insertion of Laryngoscope beyond incisor teeth until successful intubation confirmed on capnography |
| POGO score |
During Intubation |
| Hemodynamics |
1 3 & 5 minutes after Intubation |
| Airway trauma |
During Intubation |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
03/03/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
A
study titled "A comparative randomized controlled study of Kingvision
video laryngoscope, Airtraq video laryngoscope and Macintosh laryngoscope for
orotracheal intubation in adult patients scheduled for elective surgeries under
general anaesthesia" was carried out in GGH, KADAPA during the period
from January 2023 to December 2023.
Parameters
such as ease of intubation based on Intubation difficulty score (IDS), duration
of intubation, POGO score, changes in heart rate, mean arterial pressure, O2
saturation and incidence of airway trauma during laryngoscopy were noted.
In
our study, MCLG and POGO score were better with Kingvision video laryngoscope
and Airtraq video laryngoscope compared to Macintosh laryngoscope which was
statistically significant. Number of attempts for intubation was comparable and was
statistically insignificant. Alternative techniques for intubation like bougie
insertion was needed for intubation in some patients with Macintosh
laryngoscope. Lifting force was more and
laryngeal pressure was applied in some
patients intubated with Macintosh laryngoscope. IDS score was better with Kingvision video laryngoscope and
Airtraq video laryngoscope compared to Macintosh laryngoscope and was
statistically significant. Time taken for intubation was lesser with Macintosh
laryngoscope compared to Kingvision video laryngoscope and Airtraq video
laryngoscope. Hemodynamic variability was lesser with Kingvision video
laryngoscope and Airtraq video laryngoscope compared to Macintosh laryngoscope.
Airway trauma was observed in two
patients intubated with Macintosh laryngoscope. |