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

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

Study Overview

• Status: Completed
• Conditions: Airway Management
• Intervention / Treatment: Device: VBM Intubating Laryngeal Tube; Device: 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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 9RT
    • Guy's and St Thomas NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Investigators: Principal Investigator: Imran Ahmad, MBBS, Guy's and St Thomas' NHS Foundation Trust

Publications and helpful links

General Publications

• 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. No abstract available.

Helpful Links

• Link to correspondence relating to the article

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): June 5, 2019
• Study Completion (Actual): June 5, 2019

Study Registration Dates

• First Submitted: December 16, 2016
• First Submitted That Met QC Criteria: February 24, 2017
• First Posted (Actual): March 1, 2017

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 30, 2019
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Endotracheal intubation; Supraglottic device; Fibre optic scope
• Other Study ID Numbers: 16LO1210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No individual participant data will be made available