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

Phase 4

Not yet recruiting

Conditions: Peadiatric age group 0 to 7 years

Registration Number: CTRI/2025/06/088423

Lead Sponsor: D Y Patil University School of Medicine and Hospital Nerul Navi Mumbai

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

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 18

Inclusion Criteria

Patient belonging to age group 0 to 7 years Patient posted for surgery under general anaesthesia Children belonging to ASA l and ll.

Exclusion Criteria

Congenital facial deformity Difficult Airway Cases taken up as emergency.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time taken to intubate with video laryngoscope versus conventional laryngoscope	Baseline \| 1 minutes \| 3 minutes \| 5 minutes

Secondary Outcome Measures

Name	Time	Method
Number of attempts	Hemodynamic response

Trial Locations

Locations (1): D.Y Patil University School Of Medicine and Hospital
🇮🇳
Thane, MAHARASHTRA, India
D.Y Patil University School Of Medicine and Hospital
🇮🇳Thane, MAHARASHTRA, India
DrGauri Tarachand Jain
Principal investigator
8208256463
jaingauri22@gmail.com