To compare two types of airway devices proseal LMA and i-gel in children undergoing elective surgical procedures

Phase 3

Not yet recruiting

Conditions: Children of 1 -10 years undergoing elective surgeries less than 2 hrs

Registration Number: CTRI/2023/07/055505

Lead Sponsor: Anisha Pauline L

Brief Summary: The Laryngeal mask airways are supraglottic airway devices that has gained popularity over years in managing difficult airway,nonoperating room anaesthesia,day care surgeries,ophthalmologic surgeries, etc.These devices have been designed to provide and maintain seal around laryngeal inlet and are considered effective alternatives to endotracheal tube. The relatively newer second generation such as LMAs such as proseal LMA and i-gel are used widely in children. The objective of this study is to compare the efficacy and safety of their use in paediatric population undergoing elective surgeries in terms of successful airway placement,oropharyngeal leak pressure, gastric tube insertion, ease of insertion and complications anticipated during spontaneous ventilation and postoperatively

All children aged between 1 to 10years scheduled for elective surgeries with duration less than 2hr,BMI<30 and with ASA physical status of I and II meeting the inclusion criteria will be included. After informed consent, eligible patients will be advised fasting orders for solids and liquids and will be randomly allocated on the day of surgery by opaque envelope concealment method. After securing a good intravenous access after inhalational induction and connecting ASA standard monitors, the child will be deepened for LMA insertion with intravenous agents like fentanyl (1-2 mcg/kg)and propofol (1-2 mg/kg).The successful placement of LMA will be assessed on ease of insertion of LMA ,acquiring adequate tidal volumes, oropharyngeal leak pressure, ease of gastric tube insertion, any laryngospasm during induction and maintenance will be observed and after extubation staining of LMA with blood and sore throat ,hoarse cry,discomfort in throat will be observed in postanaesthesia care unit.

There are very few studies comparing proseal LMA and i-gel in paediatric population under spontaneous ventilation.Proseal LMA is considered as standard of care and from this study if i-gel proves to be noninferior to Proseal LMA,it may be used alternatively in future elective surgical day to day practices.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 54

Inclusion Criteria

1. ASA grade I and II.
1. Children of either sex aged 1-10 years 3) BMI<30 4) Mouth opening of more than 2.5cm.
1. Elective lower abdominal, minor urological and minororthopaedic surgeries of duration less than 120minutes, such as circumcision, orchidopexy, herniotomy, urethroplasty,implant exit in upper limb and lower limb.

Exclusion Criteria

1)Parent/Guardian refusal 2)Patients with active upper/lower respiratory tract infections.
1. Patients at risk of aspiration.
1. Patients with known systemic or syndromic comorbidities.
1. Patients with airway abnormalities, loose teeth.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
bilateral equal chest rise	Within 10 minutes of jntubation
Oropharyngeal leak pressure & successful placement meeting all 5 criteria of	Within 10 minutes of jntubation
EtCO2 waveform of 30 to 35 mmHg	Within 10 minutes of jntubation
no peak pressure elevation more than 30 cm H2O	Within 10 minutes of jntubation
with no audible leak	Within 10 minutes of jntubation
tidal volumes more than 6 ml per kg	Within 10 minutes of jntubation

Secondary Outcome Measures

Name	Time	Method
Ease of insertion	Ease of gastric tube placement

Trial Locations

Locations (1): Christian Medical college
🇮🇳
Vellore, TAMIL NADU, India
Christian Medical college
🇮🇳Vellore, TAMIL NADU, India
Anisha Pauline L
Principal investigator
9445652668
anishalionel11@gmail.com