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

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

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.

Official Title
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A Comparison of Two Supraglottic Devices, the VBM Intubating Laryngeal Tube and I-Gel

Conditions
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Airway Management

Intervention / Treatment
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* Device: VBM Intubating Laryngeal Tube
* Device: I-Gel


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: VBM Intubating Laryngeal Tube<br>Device: VBM Intubating Laryngeal Tube Intervention: VBM Intubating Laryngeal Tube insertion, seal pressure, endotracheal intubation | Device: VBM Intubating Laryngeal Tube<br>* 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.<br>|
| Active Comparator: I-Gel<br>Device: I-Gel Intervention: I-Gel insertion, seal pressure, endotracheal intubation | Device: I-Gel<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in seconds required for placement of supraglottic device | Time from device first enters mouth and appearance of end-tidal CO2 | Through study completion, an average of 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seal pressure measured in cmH2O | Peak seal pressure when manual ventilation is commenced | 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. | Through study completion, an average of 30minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Supraglottic device, Fibre optic scope, Endotracheal intubation