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NCT Number: NCT03067246

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

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

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Key information

Conditions

Airway Management

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guy's and St Thomas NHS Foundation Trust

London, SE1 9RT, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Time in seconds required for placement of supraglottic device

    Time frame: Through study completion, an average of 30 minutes

    Time from device first enters mouth and appearance of end-tidal CO2

Secondary outcomes

  1. Seal pressure measured in cmH2O

    Time frame: Through study completion, an average of 30 minutes

    Peak seal pressure when manual ventilation is commenced

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 1, 2017
Registry last updated
Jul 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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