NCT03067246

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Guy's and St Thomas' NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Airway Management

Interventions

Type	Name	Description
DEVICE	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.
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.

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-06-05
• Completion: 2019-06-05
• First posted: 2017-03-01
• Last updated: 2019-07-31

Locations

1 site across 1 country: United Kingdom