I-Gel Versus Disposable Laryngeal Mask (LMA) for General Anesthesia (GA) With Controlled Ventilation

Northern Health and Social Care Trust200 enrolled

Overview

Randomized controlled trial comparing performance of the I-gel and disposable Laryngeal Mask Airways under controlled ventilation. 200 patients, 100 in each arm. Measurement of peak airway and sealing pressures. Postoperative questionnaires at 1 and 24hrs. Hypothesis There is no difference between the performance\* of the I-gel and disposable laryngeal mask airways for controlled ventilation under general anesthesia. \*as defined by peak airway pressure and sealing pressures.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

200

Conditions

Healthy

Interventions

Insertion of laryngeal mask airway (AuraOnce mask)DEVICE

Insertion of laryngeal mask airway under anaesthesia: Fentanyl 1-2mcg/kg; Propofol 1-3mg/kg; Atracurium 0.5mg/kg; AuraOnce disposable laryngeal mask

Insertion of I-gel airwayDEVICE

Insertion of I-gel airway under anaesthesia; Fentanyl 1-2mcg/kg; Propofol 1-3mg/kg; Atracurium 0.5mg/kg

Measurement of airway pressuresOTHER

Measurement of peak airway pressure under steady state; measurement of device seal pressure

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Males and females. * Age 18-89 inclusive. * ASA grade 1-2. * Elective surgery Exclusion Criteria: * Emergency surgery. * Surgery within the peritoneum. * Surgery requiring prone or steep head-down positioning. * Patients at increased risk of aspiration

Outcomes

Primary Outcomes

Sealing pressure and peak airway pressure.

Time frame: Under anaesthesia.

Secondary Outcomes

Postoperative patient symptoms

Time frame: 1hr and 24hrs postoperatively

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.