Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT03502590

IGEL Laryngeal Mask Airway Device Effectiveness in Irradiated Necks

Led by NHS Lothian · Updated on 2026-02-19

62

Participants Needed

1

Research Sites

478 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

It is known that patients with head and neck cancer who have had radiation therapy to the structures of the neck are at a greater risk of difficult mask ventilation and tracheal intubation than the majority of patients undergoing general anaesthesia. Failure to maintain oxygenation can lead to catastrophic consequences for any patient undergoing general anaesthesia, such as severe hypoxic brain injury and death. As such, the current guidelines from the Difficult Airway Society promote the use of a second generation laryngeal mask airway to maintain oxygenation in the event of failed mask ventilation or tracheal intubation, a rescue technique that has in most patient groups a very high chance of success. Unfortunately these guidelines are by necessity generic guidance and do not take into account the clinical performance of these devices in specific patient groups. While there is evidence of the effectiveness of the IGEL device as the primary method of airway maintenance in many studies there are none that describe its clinical performance in a group of patients in whom the rate of failed mask ventilation and tracheal intubation are significantly higher than the general population of patients. It is therefore of great interest to have an idea of the likelihood of success of rescue ventilation with this device in a group of high risk patients.

CONDITIONS

Official Title

IGEL Laryngeal Mask Airway Device Effectiveness in Irradiated Necks

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older
  • Scheduled for an elective procedure requiring general anesthesia
  • Previous radiotherapy to the neck
Not Eligible

You will not qualify if you...

  • General anesthesia is not the primary airway plan
  • Known history of difficult intubation
  • Patient refusal to participate

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

St Johns Hospital

Livingston, United Kingdom, EH56 6PP

Actively Recruiting

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Research Team

G

Grant C Price, MBChB

CONTACT

C

Claire Gillan, MBChB

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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