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

Not Applicable

Completed

• Conditions: Airway Management
• Interventions: Device: VBM Intubating Laryngeal Tube; Device: I-Gel

• Registration Number: NCT03067246
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2016-12-16
• Study Start: 2017-01
• Study First Submitted QC: 2017-02-24
• Study First Posted: 2017-03-01
• Status Verified: 2018-02
• Primary Completion: 2019-06-05
• Study Completion: 2019-06-05
• Last Update Submitted: 2019-07-30
• Last Update Posted: 2019-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VBM Intubating Laryngeal Tube	VBM Intubating Laryngeal Tube	Device: VBM Intubating Laryngeal Tube Intervention: VBM Intubating Laryngeal Tube insertion, seal pressure, endotracheal intubation
I-Gel	I-Gel	Device: I-Gel Intervention: I-Gel insertion, seal pressure, endotracheal intubation

Primary Outcome Measures

Name	Time	Method
Time in seconds required for placement of supraglottic device	Through study completion, an average of 30 minutes	Time from device first enters mouth and appearance of end-tidal CO2

Secondary Outcome Measures

Name	Time	Method
Seal pressure measured in cmH2O	Through study completion, an average of 30 minutes	Peak seal pressure when manual ventilation is commenced
Successful endotracheal intubation through the supraglottic airway, end tidal carbon dioxide monitoring in kilopascals	Through study completion, an average of 30minutes	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.

Trial Locations

Locations (1)

Guy's and St Thomas NHS Foundation Trust; 🇬🇧 London, United Kingdom