A Comparison of the VBM Intubating Laryngeal Tube and the I-Gel

Guy's and St Thomas' NHS Foundation Trust40 enrolled

Overview

A study comparing two second generation supraglottic Airway devices, the VBM intubating laryngeal tube and the I-Gel.

This is a study comparing the use of a newer generation laryngeal mask to the 2nd generation widely used at present. The company responsible for the manufacture of this product is VBM Medizintechnik GmBH, Germany. The recent difficult airway society guidelines recommend the use of these newer generation devices and this has been the incentive to conduct this project. These newer generation supraglottic devices have an additional feature which is an extension of the mask with a balloon that sits in the oesophagus. The trial is investigating ease of placement of these devices, ventilatory pressures, leak pressure and ease of intubation through the VBM device compared to I-Gel. The position of the supraglottic device on insertion and the position of the endotracheal tube will be confirmed with a fibrescope. A follow up will take place on the same day and after 24 hours for symptoms of a sore throat postoperatively.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Airway Management

Interventions

VBM Intubating Laryngeal TubeDEVICE

The position of the VBM Intubating Laryngeal Tube will be assessed using a fibreoptic scope following balloon inflation of the cuff. Seal pressure will be assessed with the presence of the inflated cuff. Endotracheal intubation through the intubating laryngeal tube with a size 7 VBM reinforced tube will be assessed using a fiberoptic scope.

I-GelDEVICE

The position of the I-Gel will be assessed using a fibreoptic scope. The seal pressure will be assessed with the specified design of the I-Gel in the absence of a cuff. Endotracheal intubation through the I-Gel with a size 7 reinforced endotracheal tube will be assessed using a fiberoptic scope.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Any patient between the age of 18 - 70 2. Any patient having the capacity to consent 3. Any patient requiring general anaesthesia but not endotracheal intubation immediately after induction of anaesthesia. Exclusion Criteria: 1. Patient refusal 2. Patients involved in another research project 3. Patients who require endotracheal intubation immediately after induction of anaesthesia 4. Patients who are systemically unwell/unstable 5. Patients at risk of aspiration

Locations (1)

Guy's and St Thomas NHS Foundation Trust

London, United Kingdom

Outcomes

Primary Outcomes

Time in seconds required for placement of supraglottic device

Time from device first enters mouth and appearance of end-tidal CO2

Time frame: Through study completion, an average of 30 minutes

Secondary Outcomes

Seal pressure measured in cmH2O

Peak seal pressure when manual ventilation is commenced

Time frame: Through study completion, an average of 30 minutes

Successful endotracheal intubation through the supraglottic airway, end tidal carbon dioxide monitoring in kilopascals

This is performed with the endotracheal tube mounted onto the fibreoptic scope and placed through the supraglottic device. The patients will be extubated immediately following the end of the surgical procedure which may take an average of approximately 2 hours.

Time frame: Through study completion, an average of 30minutes

Data from ClinicalTrials.gov

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