A Comparative study of two different type of airway tubes in infants, for short surgeries

Recruiting

Conditions: Lower abdominal surgery

Registration Number: CTRI/2013/02/003364

Lead Sponsor: Dept of Anaesthesiology Pain Perioperative Medicine

Brief Summary: The laryngeal mask airway and similar supraglottic devices use an inflatable cuff to wedge into the upper oesophagus and provide a perilaryngeal seal. Inflatable masks provide an airway seal but can have negative impact on how these devices are inserted, how they are positioned and how they can perform. Inflation using the recommended volumes increases mask rigidity and decreases conformity with perilaryngeal structures. Mechanically, inflation can cause movement of the device. Inflatable masks also have the potential to cause tissue distortion, venous compression and nerve injury. Depending upon their material they can absorb anaesthetic gases leading to increased mucosal pressures. Size 1 LMA which is used in children upto 5 kg is vulnerable to displacement with slight movement of head of the child or anaesthesia circuit or with cuff inflation.

Currently the classical supralaryngeal airway devices (SAD) have been modified and i-gelTM airway is one of the alternative SADs which has been recently introduced.

The i-gel airway (Intrasurgical Ltd, Wokingham, Berkshire, UK) is a novel, single patient use, disposable supraglottic device made up of a thermoplastic elastomer (SEBS, styrene ethylene butadiene styrene) with a soft durometer (hardness) and gel like feel. It is designed to achieve a mirrored impression of the pharyngeal and laryngeal structures and to provide perilaryngeal seal without cuff inflation. A supraglottic airway without a cuff has potential advantages including easier insertion and use, minimal risk of tissue compression, stability after insertion (i.e. no position change with cuff inflation)

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 40

Inclusion Criteria

ASA grade I/II 2.
Weight 2Kg to 5 Kg.

Exclusion Criteria

1.ASA physical status greater than II 2.Risk of pulmonary aspiration 3.Potential difficult airway 4.Children who require surgery in positions other than supine or lithotomy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Seal pressure achieved	From induction af anaesthesia to awakening from anaesthesia

Secondary Outcome Measures

Name	Time	Method
1.Ease of insertion	2.Stability of the device

Trial Locations

Locations (1): Sir Ganga Ram hospital
🇮🇳
Central, DELHI, India
Sir Ganga Ram hospital
🇮🇳Central, DELHI, India
Dr Archna Koul
Principal investigator
01142252513
archnakoul1@gmail.com