| CTRI Number |
CTRI/2021/12/038787 [Registered on: 21/12/2021] Trial Registered Prospectively |
| Last Modified On: |
23/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between two laryngoscopes in term neonates and babies upto 6 months of age |
|
Scientific Title of Study
|
Comparison of besdata video laryngoscope with direct laryngoscope in term neonates and infants upto 6 months of age- A randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vedha Venkatesh |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Department of Anesthesiology and Critical care
JIPMER
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8940183742 |
| Fax |
|
| Email |
sundarvedhavenkatesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gnanasekaran Srinivasan |
| Designation |
Assistant Professor |
| Affiliation |
JIPMER |
| Address |
Department of Anesthesiology and Critical care
JIPMER
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9487188275 |
| Fax |
|
| Email |
gnansdr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vedha Venkatesh |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Department of Anesthesiology and Critical care
JIPMER
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8940183742 |
| Fax |
|
| Email |
sundarvedhavenkatesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| JIPMER Hospital Puducherry |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
JIPMER Hospital
Gorimedu
Puducherry
|
| 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 Vedha Venkatesh |
JIPMER |
Room no: 2/Division of Anaesthesiology
Department of Anaesthesiology and Critical care
Pondicherry
PONDICHERRY |
8940183742
sundarvedhavenkatesh@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional ethics committee JIPMER Puducherry |
Approved |
| Institutional ethics committee JIPMER Puducherry |
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 |
| Intervention |
Intubation by video laryngoscope |
Intubation with besdata video laryngoscope using miller zero size will be done and time taken for successful intubation,glottic visualization time and percentage of glottic opening will be noted.
Frequency of usage - 2
Duration - 30 to 50 seconds |
| Comparator Agent |
Intubation with direct laryngoscope |
Intubation with direct laryngoscope using miller zero size blade will be done and time taken for successful intubation, glottic visualization time and percentage of glottic opening will be noted.
Frequency of usage -2
Duration - 30 to 60 seconds |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
6.00 Month(s) |
| Gender |
Both |
| Details |
Full term Neonates and infants upto 6 months with ASA class I and II requiring general anaesthesia with orotracheal intubation for any surgical procedure |
|
| ExclusionCriteria |
| Details |
1)Patients with increased risk of gastric regurgitation and aspiration (which includes patients with anomalies like congenital diaphragmatic hernia and intestinal obstruction)
2) Patients with congenital airway anomalies
3) Patients with anticipated difficult airway (which includes patients with hydrocephalus and syndromes with features like micrognathia and retrognathia)
4) Active upper respiratory tract infection
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the time taken for successful tracheal intubation with Besdata video laryngoscope and Miller direct laryngoscope in term neonates and infants up to 6 months of age |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time for best glottic visualization |
Baseline |
| To compare first attempt intubation success rate |
NA |
| To compare POGO Score (Percentage of Glottic opening) between the two groups |
NA |
| To assess for development of complications such as airway mucosal trauma, bradycardia, esophageal intubation. |
NA |
|
|
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)
|
31/12/2021 |
| Date of Study Completion (India) |
23/05/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
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
Modification(s)
|
The anatomy of airway in infants is significantly different than of adults. Multiple anatomic differences like large tongue, floppy epiglottis, more anterior situated larynx, large occiput, smaller diameter of the airway make direct laryngoscopy and intubation difficult. Also the anesthetised neonates and infants are prone for hypoxia even with minor delay in airway management.The conventional direct laryngoscopy though commonly used and successful is limited by the requirement of alignment of line of sight of anesthetist with axis of laryngoscopic inlet. Video laryngoscope whereas uses video camera for focused view over the laryngeal inlet thereby obviating the need of alignment of laryngeal axis. Due to better glottic visualization video laryngoscopy can reduce number of intubation attempts and first attempt intubation success rate.
Therefore in this study we compare direct laryngoscope using age appropriate size miller blade with besdata video laryngoscope using zero size miller blade in term neonates and infants upto 6 months of age. With this comparison if video laryngoscope is equivalent to direct laryngoscope,then based on the results of the study video laryngoscope can be used as an alternative to direct laryngoscope in emergency and elective pediatric intubation. |