A Comparative Evaluation of two devices for airway patency in Children undergoing Daycare Surgery

Phase 4

Completed

Conditions: Paediatric patients for day care surgeries

Registration Number: CTRI/2016/08/007202

Lead Sponsor: Sir Ganga Ram Hospital

Brief Summary: The second generation supraglottic airway devices(SAD) are widely used in paediatric population. The improved features of these devices providing better airway seal and their ability to remove gastric contents have revolutionized airway management in paediatric anaesthetic practice. ProSeal Laryngeal Mask Airway (PLMA), a SAD with a gastric drain tube, has been widely used in paediatric patients under controlled ventilation. The Ambu Aura Gain is another SAD (a modification of previous supraglottic device Ambu Aura Once) which is designed to facilitate guided tracheal intubation. It has integrated gastric access channel for managing gastric contents and provides higher oropharyngeal seal pressure (OSP). It has original anatomical curve ensuring rapid placement and intubating capacity using standard endotracheal tubes. It is MRI safe and is made up of phthalate free material. It is available in paediatric sizes also. The aim of this prospective randomized study is to evaluate and compare suitability of Ambu Aura Gain as an airway device with the PLMA in paediatric daycare surgery.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

1.ASA I to II children 2.Elective daycare procedure under general anaesthesia 3.
weight 5 to 30kg.

Exclusion Criteria

ASA III / IV 2.Parent / guardian refusal 3.Patient not fulfilling ASA fasting guideline 4.Head and neck surgery and difficult airway 5.Children with sore throat or upper respiratory infection ï‚· Position other than supine.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the oropharyngeal seal pressure (OSP)	To compare the oropharyngeal seal pressure (OSP)

Secondary Outcome Measures

Name	Time	Method
1. Ease of insertion	2.Insertion time

Trial Locations

Locations (1): Operating Room,Sir Ganga Ram Hospital
🇮🇳
Delhi, DELHI, India
Operating Room,Sir Ganga Ram Hospital
🇮🇳Delhi, DELHI, India
Dr Rachna Bhutani
Principal investigator
09811199484
rachnabhutani@ymail.com