| CTRI Number |
CTRI/2024/06/068823 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
09/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare two types of laryngoscope to see voice box for securing airway - video assisted laryngoscope and direct laryngoscope in children undergoing elective surgeries under General Anaesthesia. |
|
Scientific Title of Study
|
Comparison of VL3 video laryngoscopy with macintosh direct laryngoscopy for endotracheal intubation in paediatric patients. |
| 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 Deepu U |
| Designation |
PG Resident |
| Affiliation |
MS Ramaiah Medical college |
| Address |
Department of Anaesthesiology, MS Ramaiah Medical College,
MSRIT Post,Banglore
Bangalore
KARNATAKA
560054
India |
| Phone |
7795686066 |
| Fax |
|
| Email |
deepu948211423@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geetha C R |
| Designation |
Professor and Head |
| Affiliation |
MS Ramaiah Medical college |
| Address |
Department of Anaesthesiology, MS Ramaiah Medical College,
MSRIT Post, Bangalor
Bangalore
KARNATAKA
560054
India |
| Phone |
9900482828 |
| Fax |
|
| Email |
jageedha@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetha C R |
| Designation |
Professor and Head |
| Affiliation |
MS Ramaiah Medical college |
| Address |
Department of Anaesthesiology, MS Ramaiah Medical College,
MSRIT Post, Bangalor
Bangalore
KARNATAKA
560054
India |
| Phone |
9900482828 |
| Fax |
|
| Email |
jageedha@yahoo.com |
|
|
Source of Monetary or Material Support
|
| MS Ramaiah Medical college, MSRIT Post Bangalore Karnataka
560054 India |
|
|
Primary Sponsor
|
| Name |
MS Ramaiah Medical College |
| Address |
New BEL Road, MSRIT Post, Bangolore, 560054 |
| Type of Sponsor |
Private 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 Geetha CR |
MS Ramaiah Medical College and Hospital |
Department of
Anesthesiology,
Second floor, MS
Ramaiah Medical
College, New BEL
Road, Bangalore
560054
Bangalore
KARNATAKA |
9900482828
jageedha@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MS Ramaiah Medical College Ethics Committee |
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 |
Macintosh Direct laryngoscope |
Direct laryngoscope is the most common tool used in securing airway which needs alignment of the oral, pharyngeal and laryngeal axis along the blade to obtain a view for the glottic opening.
time - 25 -30 second |
| Intervention |
VL3 video laryngoscope |
The VL3 video laryngoscope (HugeMed) is a new portable device for performing endotracheal intubation, weights 350g and has a 3.5 inch display with a 2.0 megapixel camera near tip of the blade and available in neonatal, pediatric and adult sizes in both reusable and disposable version.
Time - 30 second |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Age 02.00 to 08.00 years.
Pediatric patients undergoing elective surgeries requiring endotracheal intubation under general anesthesia.
American Society of Anesthesiologists physical status (ASA) 1 and 2.
|
|
| ExclusionCriteria |
| Details |
Parents/ Guardian refusal.
Children with anticipated difficult airway or previously documented difficult airway.
Presence of any pathology in the head or neck region.
Patient at the risk of aspiration.
Emergency endotracheal intubation or emergency surgery.
Children with any congenital syndrome.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the time to successful intubation between Macintosh direct laryngoscopy with the VL3 video laryngoscope |
Time to intubation time from insertion of laryngoscope blade passing the oral cavity until lung inflation and end tidal carbon dioxide waveform confirmation through endotracheal tube at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare
The Modified Cormack- Lehan grading.
The Percentage of glottic opening .
Time to achieve best glottic view.
Need for external manipulation.
Number of attempts required for intubation.
Ease of intubation.
Tube repositioning.
|
Time to achieve best glottic view time from blade passing oral cavity until the intubating resident s verbal announcement of that best glottic view for endotracheal intubation was achieved.
Best glottic view will be based on the modified CL grading.
Total time to successful tracheal intubation the sum of the individual intubation times determined the total time to successful tracheal intubation TTSI, if more than 1 attempt.
Tube repositioning done will be noted.
|
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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="10"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - CLINICAL STUDY WILL BE AVAILABLE AS ORIGINAL ARTICLE AS PUBLICATION IN A JOURNAL
- For how long will this data be available start date provided 01-10-2027 and end date provided 01-10-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Endotracheal intubation in children is the most vital and challenging step in securing airway for anaesthesiologists consequent to anatomical and physiological differences from adult airway. Proportionally larger head and tongue, angled vocal cards, long and floppy epiglottis, shorter trachea and neck all contribute to difficulty. Increased Oxygen consumption and reduced functional residual capacity in children contributes to reduced tolerance of apnoea time. Direct laryngoscope is the most common tool used in securing airway which needs alignment of the oral, pharyngeal and laryngeal axis along the blade to obtain a view for the glottic opening. Any misalignment in the axis results in unexpected poor glottic view requiring manipulation or at times failed intubation. Video laryngoscope (VLS) is the newest and updated technologies which uses a camera attached to the tip of the blade providing better glottic view without need for axis alignment. VLS has a place in the algorithm of difficult airway management of paediatric patients as an alternative approach to intubation in case of failed attempt by direct laryngoscope.4 Various video laryngoscope available with unique characteristic and advantages, each should be evaluated individually to establish effectiveness. The VL3 video laryngoscope (HugeMed) is a new portable device for performing endotracheal intubation, weights 350g and has a 3.5 inch display with a 2.0 megapixel camera near tip of the blade and available in neonatal, paediatric and adult sizes in both reusable and disposable version. Hence this study was designed to compare the VL3 video laryngoscope and Macintosh direct laryngoscopy in children between ages 2-8 years in terms of time of intubation. We hypothesized that the intubation time with VL3 video laryngoscope will be similar to direct laryngoscope but with better glottic view in paediatric patients. |