| CTRI Number |
CTRI/2021/01/030868 [Registered on: 29/01/2021] Trial Registered Prospectively |
| Last Modified On: |
17/09/2022 |
| 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
|
Comparison Of Intubating Conditions using King Vision Video Laryngoscope Versus I View Video Laryngoscope |
|
Scientific Title of Study
|
Comparison Of Intubating Conditions using King Vision Video Laryngoscope Versus I View Video Laryngoscope- A Randomised Comparative Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ruchi Kapoor |
| Designation |
Associate Professor |
| Affiliation |
UCMS and GTBH |
| Address |
Room no 731A 7th Floor OT Block Deptt of Anaesthesiology UCMS and GTB Hospital New Delhi
North East
DELHI
110095
India |
| Phone |
9560678023 |
| Fax |
|
| Email |
rudoc@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchi Kapoor |
| Designation |
Associate Professor |
| Affiliation |
UCMS and GTBH |
| Address |
Room no 731A 7th Floor OT Block Deptt of Anaesthesiology UCMS and GTB Hospital New Delhi
DELHI
110095
India |
| Phone |
9560678023 |
| Fax |
|
| Email |
rudoc@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Simran Sharma |
| Designation |
Post Graduate Resident 1st year |
| Affiliation |
University College of Medical Sciences |
| Address |
ICU 2nd floor Deptt of Anaesthesiology UCMS and GTB Hospital
New Delhi
North East
DELHI
110095
India |
| Phone |
9899023561 |
| Fax |
|
| Email |
simran.b137@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
UCMS and GTB Hospital |
| Address |
Deptt of Anaesthesiology, Dilshad Garden New Delhi 110095 |
| 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 Ruchi Kapoor |
UCMS and GTB Hospital |
Room no 731A 7th Floor OT Block Deptt of Anaesthesiology UCMS and GTB Hospital New Delhi 110095
North East
DELHI |
09560678023
rudoc@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Human Resources |
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 |
I-View Videolaryngoscope |
This device will be used for endotracheal intubation. |
| Comparator Agent |
Kingvision Videolaryngoscope |
This device will be used for endotracheal intubation. |
| Intervention |
One of the two airway devices will be used to perform endotracheal intubation. |
The time to successful endotracheal intubation and intubation characteristics of both the devices will be compared using the Intubation difficulty score |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Weight : 40-70 kilograms
Mallampatti grade I,II and III
ASA grade I and II
Patients scheduled for elective surgeries requiring general anaesthesia and tracheal intubation. |
|
| ExclusionCriteria |
| Details |
Patients with pre-existing cardiovascular,neurological and or psychological conditions
Obese patients(BMI>30)
Patients with risk of aspiration: pregnant females, patients of abdominal trauma, intestinal obstruction, hiatus hernia, GERD and patients with a known history of delayed gastric emptying.
Patients with visible swelling around the neck.
Mouth opening of less than 18mm.
Patients with restricted neck movements. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to successful endotracheal intubation |
Once after intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intubation difficulty score |
Once after intubation |
| POGO (Percentage of Glottic Opening) score |
Once after intubation |
| Fremantle score |
Once after intubation |
| Number of attempts required to intubate |
Once after intubation |
| Hemodynamic parameters |
Baseline: just before induction
T1: post induction
T2: pre intubation
T3: post intubation
T4: 3 minutes post intubation
T5: 5 minutes post intubation
T6: 10 minutes post intubation
T7: 15 minutes post intubation |
Trauma, if any
|
Once after intubation |
| Complications encountered during the procedure, if any. |
Once after intubation |
| Trauma occurring during the procedure, if any. |
Once after intubation. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/01/2021 |
| Date of Study Completion (India) |
20/07/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
RATIONALE : Although direct laryngoscopes
continue to be used as the standard intubating aid, various studies have shown
that video laryngoscopes offer advantages over direct laryngoscopes like a
better visualization of the vocal cords and lesser time taken to intubate
successfully using the latter. Studies have also been done to compare different
types of video laryngoscopes, but, by far, no study has been conducted to
compare King Vision video laryngoscope and I-View video laryngoscope in adult
patients. Therefore, the present randomized single blinded control study is
aimed at comparing the ease of intubation using the aforementioned
laryngoscopes. |