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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-06-05

Brief Summary

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

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Detailed Description

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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.

Conditions

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Airway Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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VBM Intubating Laryngeal Tube

Device: VBM Intubating Laryngeal Tube Intervention: VBM Intubating Laryngeal Tube insertion, seal pressure, endotracheal intubation

Group Type ACTIVE_COMPARATOR

VBM Intubating Laryngeal Tube

Intervention Type DEVICE

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-Gel

Device: I-Gel Intervention: I-Gel insertion, seal pressure, endotracheal intubation

Group Type ACTIVE_COMPARATOR

I-Gel

Intervention Type DEVICE

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.

Interventions

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VBM Intubating Laryngeal Tube

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.

Intervention Type DEVICE

I-Gel

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes