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临床试验/CTRI/2025/06/088423
CTRI/2025/06/088423尚未招募4 期

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

D Y Patil University School of Medicine and Hospital Nerul Navi Mumbai1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2025年6月20日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
18
试验地点
1
主要终点
Time taken to intubate with video laryngoscope versus conventional laryngoscope

研究概览

简要总结

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

  1. 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

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
0.00 Day(s) 至 7.00 Year(s)(—)
性别
All

入选标准

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

排除标准

  • Congenital facial deformity Difficult Airway Cases taken up as emergency.

结局指标

主要结局

Time taken to intubate with video laryngoscope versus conventional laryngoscope

时间窗: Baseline | 1 minutes | 3 minutes | 5 minutes

次要结局

  • Number of attempts(Hemodynamic response)

研究者

发起方
D Y Patil University School of Medicine and Hospital Nerul Navi Mumbai
申办方类型
Private medical college

研究点 (1)

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