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

Airway Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03067246
• Other study ID #: 16LO1210
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: June 5, 2019

Study information

• Verified date: February 2018
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 5, 2019
• Est. primary completion date: June 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Management

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Guy's and St Thomas NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Miller DM. Third generation supraglottic airways: is a new classification needed? Br J Anaesth. 2015 Oct;115(4):634-5. doi: 10.1093/bja/aev310. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Seal pressure measured in cmH2O	Peak seal pressure when manual ventilation is commenced	Through study completion, an average of 30 minutes
Secondary	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

External Links

•   Link to correspondence relating to the article