| CTRI Number |
CTRI/2024/07/069727 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the time taken for securing the airway through Channelled and Unchannelled Blades of King Vision Videolaryngoscope |
|
Scientific Title of Study
|
Comparison of the performance between channelled and unchannelled blades of king visionâ„¢ videolaryngoscope in simulated rapid sequence induction of anaesthesia- a randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yogesh Kumar |
| Designation |
Post Graduate |
| Affiliation |
University college of medical sciences and GTB Hospital Dilshad Garden Delhi |
| Address |
Room no 531 B second floor UCMS and GTB Hospital Dilshad Garden New Delhi
East
DELHI
110095
India |
| Phone |
7987570914 |
| Fax |
|
| Email |
kmryogesh54@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Yogesh Kumar |
| Designation |
Post Graduate |
| Affiliation |
University college of medical sciences and GTB Hospital Dilshad Garden Delhi |
| Address |
Room no 531 B second floor UCMS and GTB Hospital Dilshad Garden New Delhi
East
DELHI
110095
India |
| Phone |
7987570914 |
| Fax |
|
| Email |
kmryogesh54@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetanjali T Chilkoti |
| Designation |
Professor |
| Affiliation |
University college of medical sciences and GTB Hospital Dilshad Garden Delhi |
| Address |
Department of anaesthesiology and critical care, University college of medical sciences and GTB hospital Dilshad garden Delhi -110095
East
DELHI
110095
India |
| Phone |
9711210772 |
| Fax |
|
| Email |
geetanjalidr@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical Care, University College of Medical Sciences & GTB Hospital |
|
|
Primary Sponsor
|
| Name |
University college of medical sciences and GTB hospital |
| Address |
Department of anaesthesiology and critical care,University college of medical sciences and GTB hospital dilshad garden 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 Yogesh Kumar |
University College of Medical Sciences & GTB Hospital |
Department of Anaesthesiology and Critical Care, University College of Medical Sciences & GTB Hospital, Dilshad Garden, Delhi
East
DELHI |
7987570914
kmryogesh54@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Human Research (IEC-HR) University College Of Medical Sciences Delhi University Delhi |
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 |
King Vision Channelled blade Videolaryngoscope |
Videolaryngoscopy will be done by channelled blade of King Vision videolaryngoscope
Following parameters will be recorded
Time of intubation
Hemodynamic parameters that is
1 Systolic BP and Diastolic BP at Baseline and after induction and post intubation 1 min 3 min 5 min
2 Mean Arterial pressure at Baseline and after induction and post intubation 1 min 3 min 5 min
3 Heart rate at Baseline and after induction and post intubation 1 min 3 min 5 min
4 Saturation at Baseline and after induction and post intubation 1 min 3 min 5 min |
| Intervention |
King Vision Unchannelled blade Videolaryngoscope |
Videolaryngoscopy will be done using unchannelled blade of King Vision Videolaryngoscope
Following parameters will be recorded
Time of intubation
Hemodynamic parameters that is
1 Systolic BP and Diastolic BP at Baseline and after induction and post intubation 1 min 3 min 5 min
2 Mean Arterial pressure at Baseline and after induction and post intubation 1 min 3 min 5 min
3 Heart rate at Baseline and after induction and post intubation 1 min 3 min 5 min
4 Saturation at Baseline and after induction and post intubation 1 min 3 min 5 min |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and II with Modified Mallampati grade I and II with mouth opening more than 3cm with BMI less than 30 kg per m2 scheduled for elective surgeries under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1 Obstetric patients
2 Anticipated difficult airway example unanticipated difficult airway in the medical history for example Cormack and Lehane grade more than or equal to III or Airway Difficulty Score more than 8 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time taken for intubation through King Vision channelled blade Videolaryngoscope and King Vision Unchannelled blade Videolaryngoscope
|
Once,from inserting the Videolaryngoscope into the oral cavity till the confirmation of endotracheal intubation by using square wave form capnography in monitor |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 CL grade of laryngeal view
2 POGO Score
3 Time to vocal cord view
4 Number of intubation attempts
5 Hemodynamic parameters during laryngoscopy in both the groups
6 Intubation difficulty score
7 Ease of Intubation
8 Complications or any Technical problems
|
Hemodynamic parameters during laryngoscopy in both the groups will be recorded at Baseline and immediate after induction of anaesthesia and post intubation at 1min 3min and 5min |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
11/07/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Rapid sequence induction (RSI) is an anaesthetic technique indicated in patients who have an increased risk of gastric regurgitation and aspiration.The objective of this technique is to minimize the most critical period i.e. when aspiration of gastric content may occur. Videolaryngoscopy offers better glottic view as it does not require alignment of three axes i.e. oral, laryngeal and pharyngeal into one plane.On literature search, we observed that various VLs like CMAC, PENTAX, CVS, Airtraq and Channelled King Vision have been evaluated for facilitating intubation in RSI We hypothesize a higher performance of channelled VL when compared to unchannelled VL in terms of decreased time to intubation and better glottic view in RSI.On Literature search, we could not retrieve any study evaluating and comparing of the performance between channelled and unchannelled blades of King Vision videolaryngoscope in simulated rapid sequence induction of anaesthesia in patients scheduled for elective surgeries in Surgery and Gynaecology Operation theatre. Patients of either sex, aged 18-65yr, ASA grade I/II, with Modified Mallampati grade I/II, mouth opening >3cm, BMI<30 kg/m2 scheduled for elective surgeries under general anaesthesia and Exclusion criteria are Obstetric patients,Anticipated difficult airway [e.g. unanticipated difficult airway in the medical history (e.g.,Cormack and Lehane (C&L) ≥ III) or Airway Difficulty Score >8. Patient will be allocated into one of the two groups. Patients in group CB will undergo laryngoscopy using channelled blade of King Vision VL. Patients in Group UB will undergo laryngoscopy using unchannelled blade of King Vision VL. The primary outcome is to compare the Time taken for intubation between the two groups Secondary outcomes are Cormack-Lehane grade of laryngeal view,POGO Score (percentage of glottic opening),No. of intubation attempts,Hemodynamic parameters i.e. HR,SBP,DBP and MAP during laryngoscopy,Intubation difficulty score,Ease of Intubation,Complications i.e.desaturation,laryngospasm etc. |