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

NCT03067246 | Completed DMC

• 1 other identifier: 16LO1210
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Airway Management

Keywords

Supraglottic device; Fibre optic scope; Endotracheal intubation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Seal pressure measured in cmH2O

  Through study completion, an average of 30 minutes

• Successful endotracheal intubation through the supraglottic airway, end tidal carbon dioxide monitoring in kilopascals

  Through study completion, an average of 30minutes

Study Arms (2)

VBM Intubating Laryngeal Tube

ACTIVE COMPARATOR

Device: VBM Intubating Laryngeal Tube Intervention: VBM Intubating Laryngeal Tube insertion, seal pressure, endotracheal intubation

Device: VBM Intubating Laryngeal Tube

I-Gel

ACTIVE COMPARATOR

Device: I-Gel Intervention: I-Gel insertion, seal pressure, endotracheal intubation

Device: I-Gel

Interventions

VBM Intubating Laryngeal Tube DEVICE

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.

VBM Intubating Laryngeal Tube

I-Gel DEVICE

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.

I-Gel

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guy's and St Thomas NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

Related 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. No abstract available.

  PMID: 26385673 RESULT

Related Links

• Link to correspondence relating to the article

Study Officials

• Imran Ahmad, MBBS

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: March 1, 2017
• Study Start: January 1, 2017
• Primary Completion: June 5, 2019
• Study Completion: June 5, 2019
• Last Updated: July 31, 2019

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)