CTRI

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CTRI Number

CTRI/2025/06/088423 [Registered on: 09/06/2025] Trial Registered Prospectively

Last Modified On:

06/06/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Medical Device

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Safety and efficacy of video laryngoscpy versus conventional laryngoscopy for successful endotracheal intubation in pediatric patients between 0 to 7 years

Scientific Title of Study

Safety and efficacy of video laryngoscpy versus conventional laryngoscopy for successful endotracheal intubation in pediatric patients between 0 to 7 years : Prospective randomized study

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
Nil	Other

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Gauri Tarachand Jain
Designation	P G student
Affiliation	D Y PATIL SCHOOL OF MEDICINE
Address	A Block Department of Anesthesia D Y Patil School of Medicine Ayyappa Temple Rd Dr D Y Patil Vidyanagar Sector 5 Nerul Thane MAHARASHTRA 400706 India
Phone	8208256463
Fax
Email	jaingauri22@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Rochana Bakshi
Designation	Professor
Affiliation	D Y Patil School Of Medicine
Address	A Block Department of Anesthesia D Y Patil School of Medicine Ayyappa Temple Rd Dr D Y Patil Vidyanagar Sector 5 Nerul Navi Mumbai Thane MAHARASHTRA 400706 India
Phone	9323272151
Fax
Email	drrochana@yahoo.com

Details of Contact Person
Public Query

Name	Dr Rochana Bakshi
Designation	Professor
Affiliation	D Y Patil School Of Medicine
Address	A Block Department of Anesthesia D Y Patil School of Medicine Ayyappa Temple Rd Dr D Y Patil Vidyanagar Sector 5 Nerul Navi Mumbai Thane MAHARASHTRA 400706 India
Phone	9323272151
Fax
Email	drrochana@yahoo.com

Source of Monetary or Material Support

DY patil University school of medicine and hospital, Nerul Navi Mumbai, India, Department of Anaesthesiology, pin cade_400706

Primary Sponsor

Name	D Y Patil University School of Medicine and Hospital Nerul Navi Mumbai
Address	D Y Patil School Of Medicine A-Block Department of Anesthesia D Y Patil School of MedicineAyyappa Temple Rd Dr D Y Patil Vidyanagar Sector 5 Nerul Navi Mumbai
Type of Sponsor	Private medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
DrGauri Tarachand Jain	D.Y Patil University School Of Medicine and Hospital	D Y Patil School Of Medicine A-Block Department of Anesthesia D Y Patil School of MedicineAyyappa Temple Rd Dr D Y Patil Vidyanagar Sector 5 Nerul Navi Mumbai Thane MAHARASHTRA	8208256463 jaingauri22@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
The Institutional Ethics Committee for Biomedical and Health research of Dr D Y Patil Medical College and Hospital	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Peadiatric age group 0 to 7 years

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Safety and efficacy of conventional laryngoscopy	Safety and efficacy of conventional laryngoscopy for successful endotracheal intubation in pediatric Patient between 0 to 7 years
Intervention	Safety and efficacy of video laryngoscpy	Safety and efficacy of video laryngoscpy for successful endotracheal intubation in pediatric patients between 0 to 7 years

Inclusion Criteria

Age From	0.00 Day(s)
Age To	7.00 Year(s)
Gender	Both
Details	Patient belonging to age group 0 to 7 years Patient posted for surgery under general anaesthesia Children belonging to ASA l and ll

ExclusionCriteria

Details

Congenital facial deformity
Difficult Airway
Cases taken up as emergency

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Time taken to intubate with video laryngoscope versus conventional laryngoscope	Baseline 1 minutes 3 minutes 5 minutes

Secondary Outcome

Outcome	TimePoints
Number of attempts Hemodynamic response Complications	Baseline 1 minutes 3 minutes 5 minutes

Target Sample Size

Total Sample Size="18"
Sample Size from India="18"
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 4

Date of First Enrollment (India)

20/06/2025

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="2"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

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 - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
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 - Data are available indeﬁnitely at (Link to be included jaingauri22@gmail.com).

For how long will this data be available start date provided 20-06-2025 and end date provided 20-06-2028?
Response - Beginning 9 months and ending 36 months following article publication.

Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL

Brief Summary

INTRODUCTION

Securing an airway in children is a challenging task for an anaesthesiologist.

Pediatric and neonatal anatomy differs from adult anatomy in multiple significant ways.

Tracheal intubation is most usually facilitated by use of a conventional laryngoscope

Video laryngoscopy is gaining popularity for management of airways in children.

Attaching a camera to the blade’s tip may provide a better view of the glottis in both normal and troublesome pediatric airways.

AIM

Safety and efficacy of video laryngoscpy versus conventional laryngoscopy for successful endotracheal intubation in pediatric patients between day 0 to 7 years : Prospective randomized study

OBJECTIVE

Primary objective: Time taken to intubate with video laryngoscope versus conventional laryngoscope

The secondary objective :

1)Number of attempts

2)Hemodynamic response

3) complications

MATERIAL AND METHODOLOGY

· STUDY SITE = The present study will be conducted in the department of anaesthesiology of DY Patil medical college, Navi Mumbai.

· STUDY DESIGN = Prospective randomized comparative study .

· STUDY POPULATION = Patient aged between day 0 to 7 years undergoing general anaesthesia from DY Patil medical college, navi Mumbai.

· STUDY DURATION = from the date of ethics committee approval

· SAMPLE SIZE = 18 Patients

METHODOLOGY

All children posted for elective surgery will be screened on the basis of inclusion and Exclusion criteria.

Informed consent from parents or guardian will be taken.

Patient information sheet will be explained to parents or guardian.

Enrollment of the patient as per inclusion and exclusion criteria

On the day of surgery, Parental consent and Pre-operative fasting ( Six hours for meal that are solid, four hours for milk, and two hours for clear fluids and water) will be confirmed for every child.

Standard monitors will be attached :Non invasive blood pressure , Heart rate (HR) ,Oxygen saturation (SpO2), Electrocardiography (ECG).Baseline data will be recorded for all the patients.

22G intravenous cannula will be inserted on right or left hand if not already in place.

Patient will be randomised to either videolaryngoscopy (VL)group or conventional laryngoscopy (CS) group based on the flip coin method.

General Anaesthesia (GA) will be given as per standard protocol,IV Fentanyl 2mcg/kg, ketamine 1 mg/kg ,propofol 1mg/kg

adequacy of ventilation will be checked .

Atracurium 0.5mg/kg will be given for muscle relaxation. Appropriate size of endotracheal tube will be selected based on age and weight of the patient.

Procedure will be done by experienced anaesthetist that is associate professor or assistant professor.

In the conventional group, age appropriate Macintosh blade will be used to do the direct laryngoscopy, followed by intubation.

In the videolaryngoscopy group ,age appropriate BPL blade will be used and the glottis view would be seen on the camera screen and intubation will be done thereafter using the camera image as the guide.

Time taken from insertion of laryngoscope upto first appearance of EtCO2 will be noted by Principal Investigator

Number of attempts required to intubate will be noted.

Hemodynamic parameters will be noted as follows:

Baseline , 1min,3 min and 5 min after laryngoscopy .

Any complications such as trauma to oral structures, bradycardia etc will also be noted